Cognitive Change, Cognitive Decline, Diet Modification
Conditions
Brief summary
This is a pilot randomized controlled clinical trial is designed to investigate whether the Multicultural Healthy Diet (MHD), an anti-Inflammatory diet tailored to a multi-cultural population, can improve cognitive functioning in a middle aged (40-65 yr) urban population in Bronx, New York compared to a usual diet.
Detailed description
The Multicultural Healthy Diet (MHD) is a pilot randomized controlled clinical trial designed to test the effects of an 18 month intervention on cognitive function among 290 middle-aged individuals (40-65 yr). MHD is an anti-inflammatory diet tailored to a multicultural population. The emphasis of the intervention is on plant-based foods and limited animal and high saturated fat foods with focus on anti-inflammatory foods/food components specific to the cultural context of the participants. The trial will employ a parallel group design comparing the effects of the dietary intervention (MHD) on cognitive status to those of the control diet or usual diet plus modules on self-care matters such as dealing with aches and pains of aging, obtaining a health care proxy ,etc. To show that MHD can be adapted to this population serum biomarkers indicative of the MHD diet pattern such as fatty acid profile as well as other key nutrition biomarkers will be evaluated. Other aims include testing whether the MHD intervention can benefit cognitive function using real-time ambulatory assessments. The investigators will also assess plasma and serum markers of inflammation. Components of the MHD diet that are associated with stable or improved measures of cognition will also be evaluated. The clinical site for the proposed study is at the Albert Einstein College of Medicine; the ambulatory cognitive assessment reading center is at Pennsylvania State University, State College; the statistical core is at the Kaiser Permanente Washington Health Research Institute and the laboratory for biospecimen analysis is at the University of Minnesota.
Interventions
OTHERMulticultural Healthy Diet
An anti-inflammatory dietary pattern consists of a dietary pattern that has high anti-inflammatory potential
OTHERUsual Diet plus Self-Care
Usual diet plus sessions that focus on self-care such as dealing with aches and pains of aging.
Sponsors
Penn State University
Kaiser Permanente
University of Minnesota
National Institute on Aging (NIA)
National Center for Advancing Translational Sciences (NCATS)
Albert Einstein College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
The research clinician who assesses cognitive status needs to be blinded to assignment.
Intervention model description
This is a pilot randomized clinical trial to the effects of an anti-inflammatory diet on cognition in a middle-aged cohort. The comparison arm will receive information on self-care matters such as aches and pains of aging.
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* living, working, attending school or visiting Co-op City, Bronx (e.g. for shopping, doctors' visits, etc.) or communities neighboring Co-op City and between 40-65 yr of age * willingness to accept assignment to intervention or comparison diet group * willingness to participate in a study where weight loss is not a primary goal
Exclusion criteria
* cognitively impaired * history of traumatic brain injury * psychiatric illness * history of diabetes and experiencing hypoglycemia * liver disease * uncontrolled hypertension as defined as blood pressure \> 140/90 mm Hg * history of cardiovascular disease that affects physical functioning * severe chronic illness * low literacy * history of alcohol or drug dependence * hematologic disease or malignancy not in remission for more than 5 years * visual, auditory, or motor impairment that precludes cognitive testing. * chronic kidney disease on dialysis or special diet
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean Global Composite Cognition Score From Baseline | Baseline (Burst 1) and 9 months (Burst 2) | Change in global composite cognition score (standardized unit) is computed as the average of the three domain-specific Z-scores of the participant's performance on three ambulatory cognitive assessments: visuospatial working memory (Dot Grid Memory), processing speed (Symbol Search), and short-term associative memory binding (Color Shapes Task) at 9 months post baseline (Burst 1). Z-scores are centered at a population mean of 0 (i.e., a Z-score of 0 signifies that the data point(s) is equal to the population mean at study baseline for all three tasks in the composite average; positive Z-score group values indicate the number of standard deviations the data point(s) is above the mean and negative Z-score group values indicate the number of standard deviations the data point(s) is below the mean). Mean change in global composite Z-score from baseline will be reported by study arm. Increase in composite Z-scores from baseline are associated with improved cognition. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Energy-Adjusted DII Score | Baseline (Burst 1) and 9 months (Burst 2) | Energy-adjusted DII score was determined by an algorithm that summarized the inflammatory potential of the diet. This score represents a weighted sum of self-reported quantities of 28 foods per 1000 kilocalories of consumption that were then translated into Z-scores using a global comparative database of data from 11 countries by subtracting from the individual's self-report value the mean of the global database, then dividing by the SD. Z-scores are centered at a population mean of 0 (i.e., a Z-score of 0 signifies that the data point is = to the population mean at study baseline for all 3 tasks in the composite average; positive and negative Z-score group values indicate the number of SD the data point is above or below the mean, respectively). For this study, possible scoring range for 28 food parameters was -8 to 8 based on ref: Hebert JR, et.al., Perspective: The Dietary Inflammatory Index (DII®): Adv Nutr. 2019;10:185-95. Higher values are indicative of a more inflammatory diet. |
| Total Serum Folate Levels | Baseline (Burst 1) and 9 months (Burst 2) | Blood sera specimens were collected and processed at Baseline and 9-months post-intervention and shipped to University of Minnesota Advanced Research & Diagnostic Laboratory (ARDL) for total folate analysis by a validated serum folate assay. Mean total folate levels are summarized by study arm and reported in nmol/L. The lower limit of detection (LLOD) for mean total folate is 4.54 nmol/L and the upper limit of detection (ULOD) 90.8 nmol/L. Increase in this biomarker from baseline for MHD participants indicates possible adherence to an MHD dietary pattern such as eating more green leafy vegetables. |
| α-Tocopherol Levels | Baseline (Burst 1) and 9 months (Burst 2) | Blood plasma specimens were collected and processed at Baseline and 9-months post-intervention and shipped to University of Minnesota ARDL for α-tocopherol analysis by an HPLC method. α-Tocopherols were measured with a diode array detector equipped HPLC system. Mean α-tocopherol levels are summarized by study arm and reported in mcg/mL. There are no reference ranges for this biomarker from this laboratory (other than non-negative values). Increase in this biomarker from baseline for MHD participants indicates possible adherence to an MHD dietary pattern. |
| α-Carotenoid Levels | Baseline (Burst 1) and 9 months (Burst 2) | Blood plasma specimens were collected and processed at Baseline and 9-months post-intervention from a sub-sample and shipped to University of Minnesota ARDL lab for α-carotenoid analysis by an HPLC method. α-Carotenoids were measured with a diode array detector equipped HPLC system. Mean α-carotenoid levels are summarized by study arm and reported in mcg/mL. There are no reference ranges for this biomarker (other than non-negative values). Increase in this biomarker from baseline for MHD participants indicates possible adherence to an MHD dietary pattern. |
| Vitamin B12 Levels | Baseline (Burst 1) and 9 months (Burst 2) | Blood sera specimens were collected and processed at Baseline and 9-months post-intervention and shipped to University of Minnesota ARDL laboratory for Vitamin B12 analysis by a validated Vitamin B12 assay. Mean Vitamin B12 levels are summarized by study arm and reported in pg/mL. Reference ranges for this biomarker are: 232-1245 pg/mL and LLOD is 100 pg/mL. Increase in this biomarker from baseline for MHD participants indicates possible adherence to an MHD dietary pattern. |
| Fatty Acid Profile | Baseline (Burst 1) and 9 months (Burst 2) | Blood plasma specimens were collected and processed at Baseline and 9-months follow-up for a sub-sample and shipped to University of Minnesota ARDL laboratory for total fatty acid analysis by a gas chromatography method. Fatty acids are expressed as a percent of total fatty acids. Fatty acids are compared with each sample rather than measured against a standard and the range of percentage values for each fatty acid is 0-100%. Mean percentage plasma levels of the following fatty acids will be summarized by study arm for Burst 2: Sum of monounsaturated fatty acids (n=6); Long chain saturated fatty acids (fatty acids with 20 or more carbons (n=3)); EPA (eicosapentaenoic acid); DHA (docosahexaenoic acid); n3 DPA (omega three docosapentaenoic acid). Monounsaturated fat is a composite of 6 fatty acids: 16:1n7 cis, 17:1n7T, 18:1n9 cis,18:1n7 cis, 20:1n9, and 24:1n9 Long chain saturated fat is a composite of 3 fatty acids: 22:0, 23:0, and 24:0 |
| Serum Sodium | Baseline (Burst 1) and 9 months (Burst 2) | Serum specimens were collected and processed at Baseline and 9-months follow-up and shipped to University of Minnesota ARDL laboratory for analysis on Roche Cobas 8000 Chemistry Analyzer. Mean serum sodium levels are summarized by study arm and reported in mmol/L. Reference range is 136-145 mmol/L and the lower LOD is 80 mmol/L. Decreased serum sodium levels from baseline may indicate dehydration. |
| Self-reported Diet Components and Food Groups: Total Moisture | Baseline (Burst 1) and 9 months (Burst 2) | Total Moisture obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Total moisture from diet was captured by the MOIS variable field within the ASA24. This field is quantified in grams (g) of water. Possible results values are limited to values \> 0 (i.e., positive values). Basic descriptive statistics were used to summarize data by arm.ASA-2018 and 2020 |
| Self-reported Diet Components and Food Groups: Energy | Baseline (Burst 1) and 9 months (Burst 2) | Energy obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Total energy from diet was captured by the KCAL variable field within the ASA24. This field represents kilocalories (kcal) of energy. Possible results values are to values \> 500kcal. Basic descriptive statistics were used to summarize data by arm. |
| Self-reported Diet Components and Food Groups: Protein | Baseline (Burst 1) and 9 months (Burst 2) | Protein obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Protein from the diet was captured by the PROT variable field within the ASA24. This field represents grams (g) of protein consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm. |
| Self-reported Diet Components and Food Groups: Total Intact Fruits + Fruit Juices | Baseline (Burst 1) and 9 months (Burst 2) | Total Intact fruits and fruit juices obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Total Intact fruit and fruit juice consumption from the diet was captured by the F\_TOTAL variable field within the ASA24. This field represents total fruit consumption in cup equivalents (cup eq). Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm. |
| Self-reported Diet Components and Food Groups: Dark Green Vegetables | Baseline (Burst 1) and 9 months (Burst 2) | Dark Green Vegetables obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Dark green vegetable consumption from the diet was captured by the V\_DRKGR variable field within the ASA24. This field represents dark green vegetable consumption in cup equivalents (cup eq). Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm. |
| Self-reported Diet Components and Food Groups: Total Fats | Baseline (Burst 1) and 9 months (Burst 2) | Total fats obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Total fats from the diet, which consisted of total saturated fatty acids, total monounsaturated fatty acids, and total polyunsaturated fatty acids, was captured by the TFAT variable field within the ASA24. This field represents grams (g) of total fats consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm. |
| Self-reported Diet Components and Food Groups: Solid Fats | Baseline (Burst 1) and 9 months (Burst 2) | Solid fats obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Solid fats from the diet was captured by the DISCFAT\_SOL variable field within the ASA24. This field represents grams (g) of solid fats consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm. |
| Self-reported Diet Components and Food Groups: Carbohydrates | Baseline (Burst 1) and 9 months (Burst 2) | Carbohydrates obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Carbohydrates from the diet was captured by the CARB variable field within the ASA24. This field represents grams (g) of carbohydrates consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm. |
| Self-reported Diet Components and Food Groups: Total Folate From Food | Baseline (Burst 1) and 9 months (Burst 2) | Total Folate from food obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Total Folate from food was captured by the FF variable field within the ASA24. This field represents micrograms (mcg) of total folate from food consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm. |
| Self-reported Diet Components and Food Groups: Non-food Folate | Baseline (Burst 1) and 9 months (Burst 2) | Non-food Folate obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Non-food Folate was captured by the FDFE variable field within the ASA24. This field represents micrograms (mcg) of Non-food Folate consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm. |
| Self-reported Diet Components and Food Groups: Vitamin B-12 | Baseline (Burst 1) and 9 months (Burst 2) | Vitamin B-12 obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Vitamin B-12 was captured by the VB12 variable field within the ASA24. This field represents micrograms (mcg) of Vitamin B-12 consumed (including supplemental sources). Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm. |
| Self-reported Diet Components and Food Groups: Alpha Carotene | Baseline (Burst 1) and 9 months (Burst 2) | Alpha Carotene obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Alpha Carotene from the diet was captured by the ACAR variable field within the ASA24. This field represents micrograms (mcg) of Alpha Carotene consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm. |
| Self-reported Diet Components and Food Groups: Beta Carotene | Baseline (Burst 1) and 9 months (Burst 2) | Beta Carotene obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Beta Carotene from the diet was captured by the BCAR variable field within the ASA24. This field represents micrograms (mcg) of Beta Carotene consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm. |
| Self-reported Diet Components and Food Groups: Retinol | Baseline (Burst 1) and 9 months (Burst 2) | Retinol obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Retinol from the diet was captured by the RET variable field within the ASA24. This field represents micrograms (mcg) of Retinol consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm. |
| Self-reported Diet Components and Food Groups: Beta Cryptoxanthin | Baseline (Burst 1) and 9 months (Burst 2) | Beta Cryptoxanthin obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Beta Cryptoxanthin from the diet was captured by the CRYP variable field within the ASA24. This field represents micrograms (mcg) of Beta Cryptoxanthin consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm. |
| Self-reported Diet Components and Food Groups: Lycopene | Baseline (Burst 1) and 9 months (Burst 2) | Lycopene obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Lycopene from the diet was captured by the LYCO variable field within the ASA24. This field represents micrograms (mcg) of Lycopene consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm. |
| Self-reported Diet Components and Food Groups: Lutein + Zeaxanthin | Baseline (Burst 1) and 9 months (Burst 2) | Lutein + Zeaxanthin obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Lutein + Zeaxanthin from the diet was captured by the LZ variable field within the ASA24. This field represents micrograms (mcg) of Lutein + Zeaxanthin consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm. |
| Self-reported Diet Components and Food Groups: Alpha Tocopherol (Vitamin E) | Baseline (Burst 1) and 9 months (Burst 2) | Alpha Tocopherol (Vitamin E) obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Alpha Tocopherol from the diet was captured by the ATOC variable field within the ASA24. This field represents micrograms (mg) of Alpha Tocopherol consumed (including from supplemental sources). Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm. |
| Self-reported Diet Components and Food Groups: Seafood High in n-3 Fatty Acids | Baseline (Burst 1) and 9 months (Burst 2) | Seafood high in n-3 fatty acids obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Seafood high in n-3 fatty acids from the diet was captured by the M\_FISH\_HI variable field within the ASA24. This field represents ounce equivalents (oz eq) of Seafood high in n-3 fatty acids consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm. |
| Self-reported Diet Components and Food Groups: EPA (P205) | Baseline (Burst 1) and 9 months (Burst 2) | EPA (P205) obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. EPA (P205) from the diet was captured by the P205 variable field within the ASA24. This field represents grams (g) of EPA (P205) consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm. |
| Self-reported Diet Components and Food Groups: DHA (P226) | Baseline (Burst 1) and 9 months (Burst 2) | DHA (P226) obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. DHA (P226) from the diet was captured by the P226 variable field within the ASA24. This field represents grams (g) of DHA (P226) consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm. |
| Self-reported Diet Components and Food Groups: DPA (P225) | Baseline (Burst 1) and 9 months (Burst 2) | DPA (P225) obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. DPA (P225) from the diet was captured by the P225 variable field within the ASA24. This field represents grams (g) of DPA (P225) consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm. |
| Self-reported Diet Components and Food Groups: Beans and Peas (Legumes) | Baseline (Burst 1) and 9 months (Burst 2) | Beans and peas (Legumes) consumed as part of participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Legumes information from the diet was captured by the V\_LEGUMES variable field within the ASA24. This field represents cup equivalents (cup eq) of legumes consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm. |
| Self-reported Diet Components and Food Groups: Whole Grains | Baseline (Burst 1) and 9 months (Burst 2) | Whole grains consumed as part of participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Whole grains information from the diet was captured by the G\_WHOLE variable field within the ASA24. This field represents ounce equivalents (oz eq) of whole grains consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm. |
| Self-reported Diet Components and Food Groups: Cured Meats | Baseline (Burst 1) and 9 months (Burst 2) | Cured meats consumed as part of participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Cured meats information from the diet was captured by the PF\_CUREDMEAT variable field within the ASA24. This field represents ounce equivalents (oz eq) of cured meats consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm. |
| Self-reported Diet Components and Food Groups: Poultry | Baseline (Burst 1) and 9 months (Burst 2) | Poultry consumed as part of participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Poultry information from the diet was captured by the PF\_POULT variable field within the ASA24. This field represents ounce equivalents (oz eq) of poultry consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm. |
| Self-reported Diet Components and Food Groups: Nuts and Seeds | Baseline (Burst 1) and 9 months (Burst 2) | Nuts and seeds consumed as part of participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Nuts and seeds information from the diet was captured by the PF\_NUTSDS variable field within the ASA24. This field represents ounce equivalents (oz eq) of nuts and seeds consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm. |
| Dietary Inflammatory Index (DII) Score | Baseline (Burst 1) and 9 months (Burst 2) | DII score was determined by an algorithm that summarized the inflammatory potential of the diet. The DII score represents a weighted sum of the self-reported quantities of 28 foods, each translated into Z-scores using a global comparative database consisting of data from 11 countries by subtracting from the individual's self-report value the mean of the global database, then dividing by the standard deviation (SD). Z-scores are centered at a population mean of 0 (i.e., a Z-score of 0 signifies that the data point(s) is = to the population mean at study baseline for all 3 tasks in the composite average; positive and negative Z-score group values indicate the number of SD the data point(s) is above or below the mean, respectively). For this study, possible scoring range for 28 food parameters was -8 to 8 based on ref: Hebert JR, et.al., Perspective: The Dietary Inflammatory Index (DII®): Adv Nutr. 2019;10:185-95. Higher Z-score values are indicative of a more pro-inflammatory diet. |
| Self-reported Diet Components and Food Groups: Added Sugars | Baseline (Burst 1) and 9 months (Burst 2) | Added sugars consumed as part of participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Added sugars information from the diet was captured by the ADD\_SUGARS variable field within the ASA24. This field represents tablespoon equivalents (tsp eq) of added sugars consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm. |
| Symbol Search Task Performance | Baseline (Burst 1), and 9 months (Burst 2), 18 months (Burst 3), and 27 months (Burst 4) post-intervention | Symbol Search Task Performance is an ambulatory cognitive assessment of processing speed/attention. The task is administered 5 times daily throughout each 7-day measurement Burst (Baseline, 9 months, 18 months, 27 months). Mean response time in milliseconds (ms) for accurate trials will be determined and reported. Possible values ranges for Symbol Search Task Performance are \>0 ms (i.e., positive values). Lower Symbol Search Task Performance values in mean response time are indicative of improvement in cognitive processing. |
| Grid Memory Task Performance | Baseline (Burst 1), and 9 months (Burst 2), 18 months (Burst 3), and 27 months (Burst 4) post-intervention | Grid Memory Task Performance is an ambulatory cognitive assessment of visuospatial working memory. The task is administered 5 times daily throughout each 7-day measurement Burst (Baseline, 9 months, 18 months, 27 months). The mean error distance (pixel Euclidean distance, represented in pixels) of the red dots between study and recall arrays will be quantified and reported based on the completion of 4 trials. Possible value ranges for pixels are \>0 (i.e., positive values). Lower pixel values are indicative of improved short-term recall and visuospatial working memory. |
| Color Shapes Task Performance | Baseline (Burst 1), and 9 months (Burst 2), 18 months (Burst 3), and 27 months (Burst 4) post-intervention | Color Shapes Task Performance is an ambulatory cognitive assessment of short-term associative visual memory. The task is administered 5 times daily throughout each 7-day measurement Burst. The task had 2 conditions, signal present and signal absent. Hit rate represents the proportion of trials where participants correctly responded that signal was present. False alarm rate represents the proportion of trials where a signal was absent where participants incorrectly responded that a signal was present. Corrected Recognition Score represents the overall sensitivity to the signal and is calculated by subtracting the False alarm rate from the Hit rate and is summarized by study arm as described in Hakun, et.al., (2024). Mobile Monitoring of Cognitive Change (M2C2): High-Frequency Assessments and Protocol Reporting Guidelines. Possible ranges for Corrected Recognition Score are -1 to 1. Higher Corrected Recognition Rate values are indicative of better short term associative memory-binding. |
| Self-reported Diet Components and Food Groups: Cheeses | Baseline (Burst 1) and 9 months (Burst 2) | Cheeses consumed as part of participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Cheese information from the diet was captured by the D\_CHEESE variable field within the ASA24. This field represents cup equivalents (cup eq) of cheeses consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm. |
Countries
United States
Participant flow
Recruitment details
During the Covid-19 pandemic, collection of biospecimens and anthropometry data in-person was halted from 3/12/2020 to 7/16/2020; screening visits were administered via Zoom instead of in-person. Group and telephone sessions related to intervention and comparison activities continued via Zoom and telephone during this hiatus and until the end of the study. Recruitment slowed during the pandemic and follow-up was extended to allow all participants to meet their primary endpoint milestone
Pre-assignment details
Of 393 enrolled patients, 290 met eligibility criteria for randomization and were randomized into the study. For this study, Burst time intervals are as follows: Baseline (Burst 1), 9 months (Burst 2), 18 months (Burst 3), and 27 months (Burst 4) post-baseline Completion of this study was defined as the first of the following: the completion of all activities through: 1. Burst 4 (27 months post-baseline) OR 2. August 30, 2023.
Participants by arm
| Arm | Count |
|---|---|
| Anti-inflammatory Dietary Intervention (MHD Arm) 18 month intervention of dietary counseling to adhere to the Multicultural Healthy Diet or the anti-inflammatory diet,
Multicultural Healthy Diet: An anti-inflammatory dietary pattern consists of a dietary pattern that has high anti-inflammatory potential | 144 |
| Usual Diet Plus Self-Care (Comparison Arm) 18 month intervention of usual diet plus self-care modules
Usual Diet plus Self-Care: Usual diet plus sessions that focus on self-care such as dealing with aches and pains of aging. | 146 |
| Total | 290 |
Baseline characteristics
| Characteristic | Anti-inflammatory Dietary Intervention (MHD Arm) | Total | Usual Diet Plus Self-Care (Comparison Arm) |
|---|---|---|---|
| Age, Continuous | 53.3 years STANDARD_DEVIATION 7.2 | 53.7 years STANDARD_DEVIATION 7.1 | 54.0 years STANDARD_DEVIATION 7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 60 Participants | 118 Participants | 58 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 84 Participants | 172 Participants | 88 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 63 Participants | 130 Participants | 67 Participants |
| Race (NIH/OMB) More than one race | 28 Participants | 61 Participants | 33 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 10 Participants | 18 Participants | 8 Participants |
| Race (NIH/OMB) White | 34 Participants | 66 Participants | 32 Participants |
| Region of Enrollment United States | 144 participants | 290 participants | 146 participants |
| Sex: Female, Male Female | 115 Participants | 230 Participants | 115 Participants |
| Sex: Female, Male Male | 29 Participants | 60 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 144 | 0 / 146 |
| other Total, other adverse events | 73 / 144 | 71 / 146 |
| serious Total, serious adverse events | 9 / 144 | 10 / 146 |
Outcome results
Primary
Change in Mean Global Composite Cognition Score From Baseline
Change in global composite cognition score (standardized unit) is computed as the average of the three domain-specific Z-scores of the participant's performance on three ambulatory cognitive assessments: visuospatial working memory (Dot Grid Memory), processing speed (Symbol Search), and short-term associative memory binding (Color Shapes Task) at 9 months post baseline (Burst 1). Z-scores are centered at a population mean of 0 (i.e., a Z-score of 0 signifies that the data point(s) is equal to the population mean at study baseline for all three tasks in the composite average; positive Z-score group values indicate the number of standard deviations the data point(s) is above the mean and negative Z-score group values indicate the number of standard deviations the data point(s) is below the mean). Mean change in global composite Z-score from baseline will be reported by study arm. Increase in composite Z-scores from baseline are associated with improved cognition.
Time frame: Baseline (Burst 1) and 9 months (Burst 2)
Population: Participants completing at least 18 sessions for the primary three domains at Bursts 1 or 2 were analyzed. Missing and non-compliant data were multiply imputed using multivariate imputation by chained equations (MICE).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-inflammatory Dietary Intervention (MHD Arm) | Change in Mean Global Composite Cognition Score From Baseline | 0.2 Z-score | Standard Deviation 0.8 |
| Usual Diet Plus Self-Care (Comparison Arm) | Change in Mean Global Composite Cognition Score From Baseline | 0.2 Z-score | Standard Deviation 0.8 |
p-value: 0.25995% CI: [-0.15, 0.04]ANCOVA
Secondary
Color Shapes Task Performance
Color Shapes Task Performance is an ambulatory cognitive assessment of short-term associative visual memory. The task is administered 5 times daily throughout each 7-day measurement Burst. The task had 2 conditions, signal present and signal absent. Hit rate represents the proportion of trials where participants correctly responded that signal was present. False alarm rate represents the proportion of trials where a signal was absent where participants incorrectly responded that a signal was present. Corrected Recognition Score represents the overall sensitivity to the signal and is calculated by subtracting the False alarm rate from the Hit rate and is summarized by study arm as described in Hakun, et.al., (2024). Mobile Monitoring of Cognitive Change (M2C2): High-Frequency Assessments and Protocol Reporting Guidelines. Possible ranges for Corrected Recognition Score are -1 to 1. Higher Corrected Recognition Rate values are indicative of better short term associative memory-binding.
Time frame: Baseline (Burst 1), and 9 months (Burst 2), 18 months (Burst 3), and 27 months (Burst 4) post-intervention
Population: Missing data: MHD, Burst 1, (N=4); MHD, Burst 2 (N=29); MHD, Burst 3 (N=24); MHD, Burst 4 (N=20). Comparison, Burst 1 (N=0); Comparison, Burst 2 (N=31); Comparison, Burst 3 (N=34); Comparison, Burst 4 (N=15).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anti-inflammatory Dietary Intervention (MHD Arm) | Color Shapes Task Performance | Burst 3 (18 months) | 0.6 Corrected Recognition Score | Standard Deviation 0.2 |
| Anti-inflammatory Dietary Intervention (MHD Arm) | Color Shapes Task Performance | Burst 2 (9 months) | 0.6 Corrected Recognition Score | Standard Deviation 0.2 |
| Anti-inflammatory Dietary Intervention (MHD Arm) | Color Shapes Task Performance | Burst 4 (27 months) | 0.7 Corrected Recognition Score | Standard Deviation 0.2 |
| Anti-inflammatory Dietary Intervention (MHD Arm) | Color Shapes Task Performance | Burst 1 (Baseline) | 0.6 Corrected Recognition Score | Standard Deviation 0.2 |
| Usual Diet Plus Self-Care (Comparison Arm) | Color Shapes Task Performance | Burst 4 (27 months) | 0.7 Corrected Recognition Score | Standard Deviation 0.2 |
| Usual Diet Plus Self-Care (Comparison Arm) | Color Shapes Task Performance | Burst 2 (9 months) | 0.6 Corrected Recognition Score | Standard Deviation 0.2 |
| Usual Diet Plus Self-Care (Comparison Arm) | Color Shapes Task Performance | Burst 3 (18 months) | 0.6 Corrected Recognition Score | Standard Deviation 0.2 |
| Usual Diet Plus Self-Care (Comparison Arm) | Color Shapes Task Performance | Burst 1 (Baseline) | 0.6 Corrected Recognition Score | Standard Deviation 0.2 |
p-value: 0.84695% CI: [-0.09, 0.054]Generalized Estimating Equation
Secondary
Dietary Inflammatory Index (DII) Score
DII score was determined by an algorithm that summarized the inflammatory potential of the diet. The DII score represents a weighted sum of the self-reported quantities of 28 foods, each translated into Z-scores using a global comparative database consisting of data from 11 countries by subtracting from the individual's self-report value the mean of the global database, then dividing by the standard deviation (SD). Z-scores are centered at a population mean of 0 (i.e., a Z-score of 0 signifies that the data point(s) is = to the population mean at study baseline for all 3 tasks in the composite average; positive and negative Z-score group values indicate the number of SD the data point(s) is above or below the mean, respectively). For this study, possible scoring range for 28 food parameters was -8 to 8 based on ref: Hebert JR, et.al., Perspective: The Dietary Inflammatory Index (DII®): Adv Nutr. 2019;10:185-95. Higher Z-score values are indicative of a more pro-inflammatory diet.
Time frame: Baseline (Burst 1) and 9 months (Burst 2)
Population: Missing data: MHD, Burst 1 (N=1); MHD, Burst 2 (N=19). Comparison, Burst 1 (N=0); Comparison, Burst 2 (N=22).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anti-inflammatory Dietary Intervention (MHD Arm) | Dietary Inflammatory Index (DII) Score | Burst 1 (Baseline) | 1.10 Z-score | Standard Deviation 1.85 |
| Anti-inflammatory Dietary Intervention (MHD Arm) | Dietary Inflammatory Index (DII) Score | Burst 2 (9 Months) | 0.70 Z-score | Standard Deviation 2.01 |
| Usual Diet Plus Self-Care (Comparison Arm) | Dietary Inflammatory Index (DII) Score | Burst 1 (Baseline) | 1.17 Z-score | Standard Deviation 1.83 |
| Usual Diet Plus Self-Care (Comparison Arm) | Dietary Inflammatory Index (DII) Score | Burst 2 (9 Months) | 1.38 Z-score | Standard Deviation 1.76 |
p-value: 0.00195% CI: [-1.02, -0.27]ANCOVA
Secondary
Energy-Adjusted DII Score
Energy-adjusted DII score was determined by an algorithm that summarized the inflammatory potential of the diet. This score represents a weighted sum of self-reported quantities of 28 foods per 1000 kilocalories of consumption that were then translated into Z-scores using a global comparative database of data from 11 countries by subtracting from the individual's self-report value the mean of the global database, then dividing by the SD. Z-scores are centered at a population mean of 0 (i.e., a Z-score of 0 signifies that the data point is = to the population mean at study baseline for all 3 tasks in the composite average; positive and negative Z-score group values indicate the number of SD the data point is above or below the mean, respectively). For this study, possible scoring range for 28 food parameters was -8 to 8 based on ref: Hebert JR, et.al., Perspective: The Dietary Inflammatory Index (DII®): Adv Nutr. 2019;10:185-95. Higher values are indicative of a more inflammatory diet.
Time frame: Baseline (Burst 1) and 9 months (Burst 2)
Population: Missing data: MHD, Burst 1 (N=1); MHD, Burst 2 (N=19). Comparison, Burst 1 (N=0); Comparison, Burst 2 (N=22).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anti-inflammatory Dietary Intervention (MHD Arm) | Energy-Adjusted DII Score | Burst 1 (Baseline) | -0.30 Z-score | Standard Deviation 1.96 |
| Anti-inflammatory Dietary Intervention (MHD Arm) | Energy-Adjusted DII Score | Burst 2 (9 Months) | -0.98 Z-score | Standard Deviation 2.16 |
| Usual Diet Plus Self-Care (Comparison Arm) | Energy-Adjusted DII Score | Burst 1 (Baseline) | -0.30 Z-score | Standard Deviation 2.03 |
| Usual Diet Plus Self-Care (Comparison Arm) | Energy-Adjusted DII Score | Burst 2 (9 Months) | -0.09 Z-score | Standard Deviation 2.03 |
p-value: <0.00195% CI: [-1.34, -0.54]ANCOVA
Secondary
Fatty Acid Profile
Blood plasma specimens were collected and processed at Baseline and 9-months follow-up for a sub-sample and shipped to University of Minnesota ARDL laboratory for total fatty acid analysis by a gas chromatography method. Fatty acids are expressed as a percent of total fatty acids. Fatty acids are compared with each sample rather than measured against a standard and the range of percentage values for each fatty acid is 0-100%. Mean percentage plasma levels of the following fatty acids will be summarized by study arm for Burst 2: Sum of monounsaturated fatty acids (n=6); Long chain saturated fatty acids (fatty acids with 20 or more carbons (n=3)); EPA (eicosapentaenoic acid); DHA (docosahexaenoic acid); n3 DPA (omega three docosapentaenoic acid). Monounsaturated fat is a composite of 6 fatty acids: 16:1n7 cis, 17:1n7T, 18:1n9 cis,18:1n7 cis, 20:1n9, and 24:1n9 Long chain saturated fat is a composite of 3 fatty acids: 22:0, 23:0, and 24:0
Time frame: Baseline (Burst 1) and 9 months (Burst 2)
Population: Missing data: MHD, Burst 1, (N=61); MHD, Burst 2 (N=52). Comparison, Burst 1 (N=61); Comparison, Burst 2 (N=52). For the Fatty Acid Profile Outcome Measure only a subset of samples were analyzed due to cost.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anti-inflammatory Dietary Intervention (MHD Arm) | Fatty Acid Profile | Monounsaturated Fat at Burst 1 (Baseline) | 10.76 % of total fatty acid | Standard Deviation 1.3 |
| Anti-inflammatory Dietary Intervention (MHD Arm) | Fatty Acid Profile | Monounsaturated Fat at Burst 2 (9 Months) | 10.91 % of total fatty acid | Standard Deviation 1.44 |
| Anti-inflammatory Dietary Intervention (MHD Arm) | Fatty Acid Profile | Long-chain Saturated Fat at Burst 1 (Baseline) | 2.14 % of total fatty acid | Standard Deviation 0.38 |
| Anti-inflammatory Dietary Intervention (MHD Arm) | Fatty Acid Profile | Long-chain Saturated Fat at Burst 2 (9 Months) | 2.15 % of total fatty acid | Standard Deviation 0.41 |
| Anti-inflammatory Dietary Intervention (MHD Arm) | Fatty Acid Profile | EPA at Burst 1 (Baseline) | 0.98 % of total fatty acid | Standard Deviation 1.24 |
| Anti-inflammatory Dietary Intervention (MHD Arm) | Fatty Acid Profile | EPA at Burst 2 (9 Months) | 1.01 % of total fatty acid | Standard Deviation 0.9 |
| Anti-inflammatory Dietary Intervention (MHD Arm) | Fatty Acid Profile | DHA at Burst 1 (Baseline) | 3.67 % of total fatty acid | Standard Deviation 1.09 |
| Anti-inflammatory Dietary Intervention (MHD Arm) | Fatty Acid Profile | DHA at Burst 2 (9 Months) | 3.77 % of total fatty acid | Standard Deviation 1.41 |
| Anti-inflammatory Dietary Intervention (MHD Arm) | Fatty Acid Profile | n3 DPA at Burst 1 (Baseline) | 1.10 % of total fatty acid | Standard Deviation 0.18 |
| Anti-inflammatory Dietary Intervention (MHD Arm) | Fatty Acid Profile | n3 DPA at Burst 2 (9 Months) | 1.07 % of total fatty acid | Standard Deviation 0.17 |
| Usual Diet Plus Self-Care (Comparison Arm) | Fatty Acid Profile | DHA at Burst 2 (9 Months) | 3.48 % of total fatty acid | Standard Deviation 1.05 |
| Usual Diet Plus Self-Care (Comparison Arm) | Fatty Acid Profile | Monounsaturated Fat at Burst 1 (Baseline) | 11.09 % of total fatty acid | Standard Deviation 1.67 |
| Usual Diet Plus Self-Care (Comparison Arm) | Fatty Acid Profile | EPA at Burst 2 (9 Months) | 0.85 % of total fatty acid | Standard Deviation 0.44 |
| Usual Diet Plus Self-Care (Comparison Arm) | Fatty Acid Profile | Monounsaturated Fat at Burst 2 (9 Months) | 10.96 % of total fatty acid | Standard Deviation 1.58 |
| Usual Diet Plus Self-Care (Comparison Arm) | Fatty Acid Profile | n3 DPA at Burst 2 (9 Months) | 1.07 % of total fatty acid | Standard Deviation 0.18 |
| Usual Diet Plus Self-Care (Comparison Arm) | Fatty Acid Profile | Long-chain Saturated Fat at Burst 1 (Baseline) | 2.12 % of total fatty acid | Standard Deviation 0.45 |
| Usual Diet Plus Self-Care (Comparison Arm) | Fatty Acid Profile | DHA at Burst 1 (Baseline) | 3.65 % of total fatty acid | Standard Deviation 1.3 |
| Usual Diet Plus Self-Care (Comparison Arm) | Fatty Acid Profile | Long-chain Saturated Fat at Burst 2 (9 Months) | 2.23 % of total fatty acid | Standard Deviation 0.42 |
| Usual Diet Plus Self-Care (Comparison Arm) | Fatty Acid Profile | n3 DPA at Burst 1 (Baseline) | 1.09 % of total fatty acid | Standard Deviation 0.21 |
| Usual Diet Plus Self-Care (Comparison Arm) | Fatty Acid Profile | EPA at Burst 1 (Baseline) | 0.90 % of total fatty acid | Standard Deviation 0.45 |
Comparison: Statistical Analysis results for DHAp-value: 0.03995% CI: [0.01, 0.53]ANCOVA
Comparison: Statistical Analysis results for n3 DPAp-value: 0.61995% CI: [-0.06, 0.03]ANCOVA
Comparison: Statistical Analysis results for Monounsaturated Fatp-value: 0.39595% CI: [-0.2, 0.51]ANCOVA
Comparison: Statistical Analysis results for Long Chain Saturated Fatp-value: 0.01995% CI: [-0.21, -0.02]ANCOVA
Comparison: Statistical Analysis results for EPAp-value: 0.20195% CI: [-0.07, 0.31]ANCOVA
Secondary
Grid Memory Task Performance
Grid Memory Task Performance is an ambulatory cognitive assessment of visuospatial working memory. The task is administered 5 times daily throughout each 7-day measurement Burst (Baseline, 9 months, 18 months, 27 months). The mean error distance (pixel Euclidean distance, represented in pixels) of the red dots between study and recall arrays will be quantified and reported based on the completion of 4 trials. Possible value ranges for pixels are \>0 (i.e., positive values). Lower pixel values are indicative of improved short-term recall and visuospatial working memory.
Time frame: Baseline (Burst 1), and 9 months (Burst 2), 18 months (Burst 3), and 27 months (Burst 4) post-intervention
Population: Missing data: MHD, Burst 1, (N=4); MHD, Burst 2 (N=29); MHD, Burst 3 (N=24); MHD, Burst 4 (N=20). Comparison, Burst 1 (N=0); Comparison, Burst 2 (N=31); Comparison, Burst 3 (N=34); Comparison, Burst 4 (N=15).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anti-inflammatory Dietary Intervention (MHD Arm) | Grid Memory Task Performance | Burst 1 (Baseline) | 34.0 pixels | Standard Deviation 15.6 |
| Anti-inflammatory Dietary Intervention (MHD Arm) | Grid Memory Task Performance | Burst 2 (9 months) | 29.0 pixels | Standard Deviation 14.7 |
| Anti-inflammatory Dietary Intervention (MHD Arm) | Grid Memory Task Performance | Burst 3 (18 months) | 26.8 pixels | Standard Deviation 15.5 |
| Anti-inflammatory Dietary Intervention (MHD Arm) | Grid Memory Task Performance | Burst 4 (27 months) | 25.6 pixels | Standard Deviation 15.7 |
| Usual Diet Plus Self-Care (Comparison Arm) | Grid Memory Task Performance | Burst 4 (27 months) | 27.4 pixels | Standard Deviation 16.3 |
| Usual Diet Plus Self-Care (Comparison Arm) | Grid Memory Task Performance | Burst 1 (Baseline) | 35.2 pixels | Standard Deviation 15.3 |
| Usual Diet Plus Self-Care (Comparison Arm) | Grid Memory Task Performance | Burst 3 (18 months) | 31.6 pixels | Standard Deviation 15.8 |
| Usual Diet Plus Self-Care (Comparison Arm) | Grid Memory Task Performance | Burst 2 (9 months) | 30.4 pixels | Standard Deviation 15.4 |
p-value: 0.5595% CI: [-0.27, 0.51]Mixed Models Analysis
Secondary
Self-reported Diet Components and Food Groups: Added Sugars
Added sugars consumed as part of participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Added sugars information from the diet was captured by the ADD\_SUGARS variable field within the ASA24. This field represents tablespoon equivalents (tsp eq) of added sugars consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.
Time frame: Baseline (Burst 1) and 9 months (Burst 2)
Population: Missing data: MHD, Burst 1, (N=1); MHD, Burst 2 (N=19). Comparison, Burst 1 (N=0); Comparison, Burst 2 (N=22).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anti-inflammatory Dietary Intervention (MHD Arm) | Self-reported Diet Components and Food Groups: Added Sugars | Burst 1 (Baseline) | 10.06 tsp eq | Standard Deviation 7.57 |
| Anti-inflammatory Dietary Intervention (MHD Arm) | Self-reported Diet Components and Food Groups: Added Sugars | Burst 2 (9 Months) | 7.91 tsp eq | Standard Deviation 6.02 |
| Usual Diet Plus Self-Care (Comparison Arm) | Self-reported Diet Components and Food Groups: Added Sugars | Burst 1 (Baseline) | 9.91 tsp eq | Standard Deviation 6.79 |
| Usual Diet Plus Self-Care (Comparison Arm) | Self-reported Diet Components and Food Groups: Added Sugars | Burst 2 (9 Months) | 9.31 tsp eq | Standard Deviation 6.89 |
p-value: 0.04295% CI: [-2.81, -0.06]ANCOVA
Secondary
Self-reported Diet Components and Food Groups: Alpha Carotene
Alpha Carotene obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Alpha Carotene from the diet was captured by the ACAR variable field within the ASA24. This field represents micrograms (mcg) of Alpha Carotene consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.
Time frame: Baseline (Burst 1) and 9 months (Burst 2)
Population: Missing data: MHD, Burst 1, (N=1); MHD, Burst 2 (N=19). Comparison, Burst 1 (N=0); Comparison, Burst 2 (N=22).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anti-inflammatory Dietary Intervention (MHD Arm) | Self-reported Diet Components and Food Groups: Alpha Carotene | Burst 1 (Baseline) | 568.66 mcg | Standard Deviation 900.88 |
| Anti-inflammatory Dietary Intervention (MHD Arm) | Self-reported Diet Components and Food Groups: Alpha Carotene | Burst 2 (9 Months) | 586.56 mcg | Standard Deviation 858.46 |
| Usual Diet Plus Self-Care (Comparison Arm) | Self-reported Diet Components and Food Groups: Alpha Carotene | Burst 1 (Baseline) | 448.66 mcg | Standard Deviation 676.44 |
| Usual Diet Plus Self-Care (Comparison Arm) | Self-reported Diet Components and Food Groups: Alpha Carotene | Burst 2 (9 Months) | 392.19 mcg | Standard Deviation 626.37 |
p-value: 0.19195% CI: [-58.62, 295.76]ANCOVA
Secondary
Self-reported Diet Components and Food Groups: Alpha Tocopherol (Vitamin E)
Alpha Tocopherol (Vitamin E) obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Alpha Tocopherol from the diet was captured by the ATOC variable field within the ASA24. This field represents micrograms (mg) of Alpha Tocopherol consumed (including from supplemental sources). Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.
Time frame: Baseline (Burst 1) and 9 months (Burst 2)
Population: Missing data: MHD, Burst 1, (N=1); MHD, Burst 2 (N=19). Comparison, Burst 1 (N=0); Comparison, Burst 2 (N=22).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anti-inflammatory Dietary Intervention (MHD Arm) | Self-reported Diet Components and Food Groups: Alpha Tocopherol (Vitamin E) | Burst 1 (Baseline) | 7.48 mg | Standard Deviation 3.07 |
| Anti-inflammatory Dietary Intervention (MHD Arm) | Self-reported Diet Components and Food Groups: Alpha Tocopherol (Vitamin E) | Burst 2 (9 Months) | 8.69 mg | Standard Deviation 5.34 |
| Usual Diet Plus Self-Care (Comparison Arm) | Self-reported Diet Components and Food Groups: Alpha Tocopherol (Vitamin E) | Burst 1 (Baseline) | 7.59 mg | Standard Deviation 3.87 |
| Usual Diet Plus Self-Care (Comparison Arm) | Self-reported Diet Components and Food Groups: Alpha Tocopherol (Vitamin E) | Burst 2 (9 Months) | 7.34 mg | Standard Deviation 3.41 |
p-value: 0.01195% CI: [0.32, 2.35]ANCOVA
Secondary
Self-reported Diet Components and Food Groups: Beans and Peas (Legumes)
Beans and peas (Legumes) consumed as part of participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Legumes information from the diet was captured by the V\_LEGUMES variable field within the ASA24. This field represents cup equivalents (cup eq) of legumes consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.
Time frame: Baseline (Burst 1) and 9 months (Burst 2)
Population: Missing data: MHD, Burst 1, (N=1); MHD, Burst 2 (N=19). Comparison, Burst 1 (N=0); Comparison, Burst 2 (N=22).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anti-inflammatory Dietary Intervention (MHD Arm) | Self-reported Diet Components and Food Groups: Beans and Peas (Legumes) | Burst 1 (Baseline) | 0.12 cup eq | Standard Deviation 0.17 |
| Anti-inflammatory Dietary Intervention (MHD Arm) | Self-reported Diet Components and Food Groups: Beans and Peas (Legumes) | Burst 2 (9 Months) | 0.14 cup eq | Standard Deviation 0.22 |
| Usual Diet Plus Self-Care (Comparison Arm) | Self-reported Diet Components and Food Groups: Beans and Peas (Legumes) | Burst 1 (Baseline) | 0.1 cup eq | Standard Deviation 0.16 |
| Usual Diet Plus Self-Care (Comparison Arm) | Self-reported Diet Components and Food Groups: Beans and Peas (Legumes) | Burst 2 (9 Months) | 0.09 cup eq | Standard Deviation 0.14 |
p-value: 0.03695% CI: [0, 0.09]ANCOVA
Secondary
Self-reported Diet Components and Food Groups: Beta Carotene
Beta Carotene obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Beta Carotene from the diet was captured by the BCAR variable field within the ASA24. This field represents micrograms (mcg) of Beta Carotene consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.
Time frame: Baseline (Burst 1) and 9 months (Burst 2)
Population: Missing data: MHD, Burst 1, (N=1); MHD, Burst 2 (N=19). Comparison, Burst 1 (N=0); Comparison, Burst 2 (N=22).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anti-inflammatory Dietary Intervention (MHD Arm) | Self-reported Diet Components and Food Groups: Beta Carotene | Burst 1 (Baseline) | 3464.67 mcg | Standard Deviation 3758.65 |
| Anti-inflammatory Dietary Intervention (MHD Arm) | Self-reported Diet Components and Food Groups: Beta Carotene | Burst 2 (9 Months) | 4040.06 mcg | Standard Deviation 3887.57 |
| Usual Diet Plus Self-Care (Comparison Arm) | Self-reported Diet Components and Food Groups: Beta Carotene | Burst 1 (Baseline) | 3389.68 mcg | Standard Deviation 4072.72 |
| Usual Diet Plus Self-Care (Comparison Arm) | Self-reported Diet Components and Food Groups: Beta Carotene | Burst 2 (9 Months) | 2948.25 mcg | Standard Deviation 2823.76 |
p-value: 0.01995% CI: [164.63, 1745.74]ANCOVA
Secondary
Self-reported Diet Components and Food Groups: Beta Cryptoxanthin
Beta Cryptoxanthin obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Beta Cryptoxanthin from the diet was captured by the CRYP variable field within the ASA24. This field represents micrograms (mcg) of Beta Cryptoxanthin consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.
Time frame: Baseline (Burst 1) and 9 months (Burst 2)
Population: Missing data: MHD, Burst 1, (N=1); MHD, Burst 2 (N=19). Comparison, Burst 1 (N=0); Comparison, Burst 2 (N=22).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anti-inflammatory Dietary Intervention (MHD Arm) | Self-reported Diet Components and Food Groups: Beta Cryptoxanthin | Burst 1 (Baseline) | 96.49 mcg | Standard Deviation 166.36 |
| Anti-inflammatory Dietary Intervention (MHD Arm) | Self-reported Diet Components and Food Groups: Beta Cryptoxanthin | Burst 2 (9 Months) | 81.28 mcg | Standard Deviation 111.66 |
| Usual Diet Plus Self-Care (Comparison Arm) | Self-reported Diet Components and Food Groups: Beta Cryptoxanthin | Burst 1 (Baseline) | 57.57 mcg | Standard Deviation 84.37 |
| Usual Diet Plus Self-Care (Comparison Arm) | Self-reported Diet Components and Food Groups: Beta Cryptoxanthin | Burst 2 (9 Months) | 57.41 mcg | Standard Deviation 63.53 |
p-value: 0.1895% CI: [-6.78, 36.45]ANCOVA
Secondary
Self-reported Diet Components and Food Groups: Carbohydrates
Carbohydrates obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Carbohydrates from the diet was captured by the CARB variable field within the ASA24. This field represents grams (g) of carbohydrates consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.
Time frame: Baseline (Burst 1) and 9 months (Burst 2)
Population: Missing data: MHD, Burst 1, (N=1); MHD, Burst 2 (N=19). Comparison, Burst 1 (N=0); Comparison, Burst 2 (N=22).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anti-inflammatory Dietary Intervention (MHD Arm) | Self-reported Diet Components and Food Groups: Carbohydrates | Burst 2 (Baseline) | 181.11 g | Standard Deviation 74.37 |
| Anti-inflammatory Dietary Intervention (MHD Arm) | Self-reported Diet Components and Food Groups: Carbohydrates | Burst 2 (9 Months) | 169.66 g | Standard Deviation 71.27 |
| Usual Diet Plus Self-Care (Comparison Arm) | Self-reported Diet Components and Food Groups: Carbohydrates | Burst 2 (Baseline) | 176.49 g | Standard Deviation 66.03 |
| Usual Diet Plus Self-Care (Comparison Arm) | Self-reported Diet Components and Food Groups: Carbohydrates | Burst 2 (9 Months) | 169.23 g | Standard Deviation 67.2 |
p-value: 0.63995% CI: [-16.18, 9.92]ANCOVA
Secondary
Self-reported Diet Components and Food Groups: Cheeses
Cheeses consumed as part of participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Cheese information from the diet was captured by the D\_CHEESE variable field within the ASA24. This field represents cup equivalents (cup eq) of cheeses consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.
Time frame: Baseline (Burst 1) and 9 months (Burst 2)
Population: Missing data: MHD, Burst 1, (N=1); MHD, Burst 2 (N=19). Comparison, Burst 1 (N=0); Comparison, Burst 2 (N=22).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anti-inflammatory Dietary Intervention (MHD Arm) | Self-reported Diet Components and Food Groups: Cheeses | Burst 1 (Baseline) | 0.58 cup eq | Standard Deviation 0.48 |
| Anti-inflammatory Dietary Intervention (MHD Arm) | Self-reported Diet Components and Food Groups: Cheeses | Burst 2 (9 Months) | 0.51 cup eq | Standard Deviation 0.54 |
| Usual Diet Plus Self-Care (Comparison Arm) | Self-reported Diet Components and Food Groups: Cheeses | Burst 1 (Baseline) | 0.62 cup eq | Standard Deviation 0.6 |
| Usual Diet Plus Self-Care (Comparison Arm) | Self-reported Diet Components and Food Groups: Cheeses | Burst 2 (9 Months) | 0.54 cup eq | Standard Deviation 0.48 |
p-value: 0.89395% CI: [-0.13, 0.11]ANCOVA
Secondary
Self-reported Diet Components and Food Groups: Cured Meats
Cured meats consumed as part of participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Cured meats information from the diet was captured by the PF\_CUREDMEAT variable field within the ASA24. This field represents ounce equivalents (oz eq) of cured meats consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.
Time frame: Baseline (Burst 1) and 9 months (Burst 2)
Population: Missing data: MHD, Burst 1, (N=1); MHD, Burst 2 (N=19). Comparison, Burst 1 (N=0); Comparison, Burst 2 (N=22).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anti-inflammatory Dietary Intervention (MHD Arm) | Self-reported Diet Components and Food Groups: Cured Meats | Burst 1 (Baseline) | 0.74 oz eq | Standard Deviation 0.93 |
| Anti-inflammatory Dietary Intervention (MHD Arm) | Self-reported Diet Components and Food Groups: Cured Meats | Burst 2 (9 Months) | 0.63 oz eq | Standard Deviation 0.82 |
| Usual Diet Plus Self-Care (Comparison Arm) | Self-reported Diet Components and Food Groups: Cured Meats | Burst 1 (Baseline) | 0.64 oz eq | Standard Deviation 0.83 |
| Usual Diet Plus Self-Care (Comparison Arm) | Self-reported Diet Components and Food Groups: Cured Meats | Burst 2 (9 Months) | 0.76 oz eq | Standard Deviation 0.95 |
p-value: 0.11995% CI: [-0.38, 0.04]ANCOVA
Secondary
Self-reported Diet Components and Food Groups: Dark Green Vegetables
Dark Green Vegetables obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Dark green vegetable consumption from the diet was captured by the V\_DRKGR variable field within the ASA24. This field represents dark green vegetable consumption in cup equivalents (cup eq). Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.
Time frame: Baseline (Burst 1) and 9 months (Burst 2)
Population: Missing data: MHD, Burst 1, (N=1); MHD, Burst 2 (N=19). Comparison, Burst 1 (N=0); Comparison, Burst 2 (N=22).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anti-inflammatory Dietary Intervention (MHD Arm) | Self-reported Diet Components and Food Groups: Dark Green Vegetables | Burst 1 (Baseline) | 0.3 cup eq | Standard Deviation 0.33 |
| Anti-inflammatory Dietary Intervention (MHD Arm) | Self-reported Diet Components and Food Groups: Dark Green Vegetables | Burst 2 (9 Months) | 0.43 cup eq | Standard Deviation 0.45 |
| Usual Diet Plus Self-Care (Comparison Arm) | Self-reported Diet Components and Food Groups: Dark Green Vegetables | Burst 1 (Baseline) | 0.33 cup eq | Standard Deviation 0.34 |
| Usual Diet Plus Self-Care (Comparison Arm) | Self-reported Diet Components and Food Groups: Dark Green Vegetables | Burst 2 (9 Months) | 0.28 cup eq | Standard Deviation 0.28 |
p-value: <0.00195% CI: [0.08, 0.26]ANCOVA
Secondary
Self-reported Diet Components and Food Groups: DHA (P226)
DHA (P226) obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. DHA (P226) from the diet was captured by the P226 variable field within the ASA24. This field represents grams (g) of DHA (P226) consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.
Time frame: Baseline (Burst 1) and 9 months (Burst 2)
Population: Missing data: MHD, Burst 1, (N=1); MHD, Burst 2 (N=19). Comparison, Burst 1 (N=0); Comparison, Burst 2 (N=22).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anti-inflammatory Dietary Intervention (MHD Arm) | Self-reported Diet Components and Food Groups: DHA (P226) | Burst 1 (Baseline) | 0.14 g | Standard Deviation 0.17 |
| Anti-inflammatory Dietary Intervention (MHD Arm) | Self-reported Diet Components and Food Groups: DHA (P226) | Burst 2 (9 Months) | 0.13 g | Standard Deviation 0.16 |
| Usual Diet Plus Self-Care (Comparison Arm) | Self-reported Diet Components and Food Groups: DHA (P226) | Burst 1 (Baseline) | 0.12 g | Standard Deviation 0.16 |
| Usual Diet Plus Self-Care (Comparison Arm) | Self-reported Diet Components and Food Groups: DHA (P226) | Burst 2 (9 Months) | 0.1 g | Standard Deviation 0.12 |
p-value: 0.11695% CI: [-0.01, 0.06]ANCOVA
Secondary
Self-reported Diet Components and Food Groups: DPA (P225)
DPA (P225) obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. DPA (P225) from the diet was captured by the P225 variable field within the ASA24. This field represents grams (g) of DPA (P225) consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.
Time frame: Baseline (Burst 1) and 9 months (Burst 2)
Population: Missing data: MHD, Burst 1, (N=1); MHD, Burst 2 (N=19). Comparison, Burst 1 (N=0); Comparison, Burst 2 (N=22).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anti-inflammatory Dietary Intervention (MHD Arm) | Self-reported Diet Components and Food Groups: DPA (P225) | Burst 1 (Baseline) | 0.03 g | Standard Deviation 0.03 |
| Anti-inflammatory Dietary Intervention (MHD Arm) | Self-reported Diet Components and Food Groups: DPA (P225) | Burst 2 (9 Months) | 0.03 g | Standard Deviation 0.03 |
| Usual Diet Plus Self-Care (Comparison Arm) | Self-reported Diet Components and Food Groups: DPA (P225) | Burst 1 (Baseline) | 0.03 g | Standard Deviation 0.03 |
| Usual Diet Plus Self-Care (Comparison Arm) | Self-reported Diet Components and Food Groups: DPA (P225) | Burst 2 (9 Months) | 0.02 g | Standard Deviation 0.02 |
p-value: 0.21395% CI: [0, 0.01]ANCOVA
Secondary
Self-reported Diet Components and Food Groups: Energy
Energy obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Total energy from diet was captured by the KCAL variable field within the ASA24. This field represents kilocalories (kcal) of energy. Possible results values are to values \> 500kcal. Basic descriptive statistics were used to summarize data by arm.
Time frame: Baseline (Burst 1) and 9 months (Burst 2)
Population: Missing data: MHD, Burst 1 (N=1); MHD, Burst 2 (N=19). Comparison, Burst 1 (N=0); Comparison, Burst 2, (N=22).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anti-inflammatory Dietary Intervention (MHD Arm) | Self-reported Diet Components and Food Groups: Energy | Burst 1 (Baseline) | 1622.31 kcal | Standard Deviation 574.26 |
| Anti-inflammatory Dietary Intervention (MHD Arm) | Self-reported Diet Components and Food Groups: Energy | Burst 2 (9 Months) | 1545.25 kcal | Standard Deviation 552.32 |
| Usual Diet Plus Self-Care (Comparison Arm) | Self-reported Diet Components and Food Groups: Energy | Burst 1 (Baseline) | 1608.62 kcal | Standard Deviation 518 |
| Usual Diet Plus Self-Care (Comparison Arm) | Self-reported Diet Components and Food Groups: Energy | Burst 2 (9 Months) | 1560.3 kcal | Standard Deviation 532.73 |
p-value: 0.64595% CI: [-129.16, 79.89]ANCOVA
Secondary
Self-reported Diet Components and Food Groups: EPA (P205)
EPA (P205) obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. EPA (P205) from the diet was captured by the P205 variable field within the ASA24. This field represents grams (g) of EPA (P205) consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.
Time frame: Baseline (Burst 1) and 9 months (Burst 2)
Population: Missing data: MHD, Burst 1, (N=1); MHD, Burst 2 (N=19). Comparison, Burst 1 (N=0); Comparison, Burst 2 (N=22).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anti-inflammatory Dietary Intervention (MHD Arm) | Self-reported Diet Components and Food Groups: EPA (P205) | Burst 1 (Baseline) | 0.07 g | Standard Deviation 0.01 |
| Anti-inflammatory Dietary Intervention (MHD Arm) | Self-reported Diet Components and Food Groups: EPA (P205) | Burst 2 (9 Months) | 0.07 g | Standard Deviation 0.08 |
| Usual Diet Plus Self-Care (Comparison Arm) | Self-reported Diet Components and Food Groups: EPA (P205) | Burst 1 (Baseline) | 0.06 g | Standard Deviation 0.08 |
| Usual Diet Plus Self-Care (Comparison Arm) | Self-reported Diet Components and Food Groups: EPA (P205) | Burst 2 (9 Months) | 0.05 g | Standard Deviation 0.07 |
p-value: 0.27395% CI: [-0.01, 0.03]ANCOVA
Secondary
Self-reported Diet Components and Food Groups: Lutein + Zeaxanthin
Lutein + Zeaxanthin obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Lutein + Zeaxanthin from the diet was captured by the LZ variable field within the ASA24. This field represents micrograms (mcg) of Lutein + Zeaxanthin consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.
Time frame: Baseline (Burst 1) and 9 months (Burst 2)
Population: Missing data: MHD, Burst 1, (N=1); MHD, Burst 2 (N=19). Comparison, Burst 1 (N=0); Comparison, Burst 2 (N=22).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anti-inflammatory Dietary Intervention (MHD Arm) | Self-reported Diet Components and Food Groups: Lutein + Zeaxanthin | Burst 1 (Baseline) | 2885.48 mcg | Standard Deviation 3661.72 |
| Anti-inflammatory Dietary Intervention (MHD Arm) | Self-reported Diet Components and Food Groups: Lutein + Zeaxanthin | Burst 2 (9 Months) | 3570.56 mcg | Standard Deviation 4028.1 |
| Usual Diet Plus Self-Care (Comparison Arm) | Self-reported Diet Components and Food Groups: Lutein + Zeaxanthin | Burst 1 (Baseline) | 2765.1 mcg | Standard Deviation 4110.87 |
| Usual Diet Plus Self-Care (Comparison Arm) | Self-reported Diet Components and Food Groups: Lutein + Zeaxanthin | Burst 2 (9 Months) | 2609.09 mcg | Standard Deviation 3357.6 |
p-value: 0.08395% CI: [-99.73, 1667.85]ANCOVA
Secondary
Self-reported Diet Components and Food Groups: Lycopene
Lycopene obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Lycopene from the diet was captured by the LYCO variable field within the ASA24. This field represents micrograms (mcg) of Lycopene consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.
Time frame: Baseline (Burst 1) and 9 months (Burst 2)
Population: Missing data: MHD, Burst 1, (N=1); MHD, Burst 2 (N=19). Comparison, Burst 1 (N=0); Comparison, Burst 2 (N=22).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anti-inflammatory Dietary Intervention (MHD Arm) | Self-reported Diet Components and Food Groups: Lycopene | Burst 1 (Baseline) | 3905.68 mcg | Standard Deviation 5106.71 |
| Anti-inflammatory Dietary Intervention (MHD Arm) | Self-reported Diet Components and Food Groups: Lycopene | Burst 2 (9 Months) | 3685.28 mcg | Standard Deviation 4671.61 |
| Usual Diet Plus Self-Care (Comparison Arm) | Self-reported Diet Components and Food Groups: Lycopene | Burst 1 (Baseline) | 3558.21 mcg | Standard Deviation 3819.37 |
| Usual Diet Plus Self-Care (Comparison Arm) | Self-reported Diet Components and Food Groups: Lycopene | Burst 2 (9 Months) | 3244.35 mcg | Standard Deviation 2902.16 |
p-value: 0.37995% CI: [-534.05, 1406.33]ANCOVA
Secondary
Self-reported Diet Components and Food Groups: Non-food Folate
Non-food Folate obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Non-food Folate was captured by the FDFE variable field within the ASA24. This field represents micrograms (mcg) of Non-food Folate consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.
Time frame: Baseline (Burst 1) and 9 months (Burst 2)
Population: Missing data: MHD, Burst 1, (N=1); MHD, Burst 2 (N=19). Comparison, Burst 1 (N=0); Comparison, Burst 2 (N=22).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anti-inflammatory Dietary Intervention (MHD Arm) | Self-reported Diet Components and Food Groups: Non-food Folate | Burst 1 (Baseline) | 125.15 mcg | Standard Deviation 86.02 |
| Anti-inflammatory Dietary Intervention (MHD Arm) | Self-reported Diet Components and Food Groups: Non-food Folate | Burst 2 (9 Months) | 109.97 mcg | Standard Deviation 80.89 |
| Usual Diet Plus Self-Care (Comparison Arm) | Self-reported Diet Components and Food Groups: Non-food Folate | Burst 1 (Baseline) | 130.78 mcg | Standard Deviation 108.64 |
| Usual Diet Plus Self-Care (Comparison Arm) | Self-reported Diet Components and Food Groups: Non-food Folate | Burst 2 (9 Months) | 127.73 mcg | Standard Deviation 98.76 |
p-value: 0.11595% CI: [-34.44, 3.69]ANCOVA
Secondary
Self-reported Diet Components and Food Groups: Nuts and Seeds
Nuts and seeds consumed as part of participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Nuts and seeds information from the diet was captured by the PF\_NUTSDS variable field within the ASA24. This field represents ounce equivalents (oz eq) of nuts and seeds consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.
Time frame: Baseline (Burst 1) and 9 months (Burst 2)
Population: Missing data: MHD, Burst 1, (N=1); MHD, Burst 2 (N=19). Comparison, Burst 1 (N=0); Comparison, Burst 2 (N=22).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anti-inflammatory Dietary Intervention (MHD Arm) | Self-reported Diet Components and Food Groups: Nuts and Seeds | Burst 1 (Baseline) | 0.57 oz eq | Standard Deviation 0.91 |
| Anti-inflammatory Dietary Intervention (MHD Arm) | Self-reported Diet Components and Food Groups: Nuts and Seeds | Burst 2 (9 Months) | 0.82 oz eq | Standard Deviation 1.43 |
| Usual Diet Plus Self-Care (Comparison Arm) | Self-reported Diet Components and Food Groups: Nuts and Seeds | Burst 1 (Baseline) | 0.58 oz eq | Standard Deviation 0.94 |
| Usual Diet Plus Self-Care (Comparison Arm) | Self-reported Diet Components and Food Groups: Nuts and Seeds | Burst 2 (9 Months) | 0.56 oz eq | Standard Deviation 0.88 |
p-value: 0.08895% CI: [-0.04, 0.53]ANCOVA
Secondary
Self-reported Diet Components and Food Groups: Poultry
Poultry consumed as part of participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Poultry information from the diet was captured by the PF\_POULT variable field within the ASA24. This field represents ounce equivalents (oz eq) of poultry consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.
Time frame: Baseline (Burst 1) and 9 months (Burst 2)
Population: Missing data: MHD, Burst 1, (N=1); MHD, Burst 2 (N=19). Comparison, Burst 1 (N=0); Comparison, Burst 2 (N=22).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anti-inflammatory Dietary Intervention (MHD Arm) | Self-reported Diet Components and Food Groups: Poultry | Burst 1 (Baseline) | 1.82 oz eq | Standard Deviation 1.65 |
| Anti-inflammatory Dietary Intervention (MHD Arm) | Self-reported Diet Components and Food Groups: Poultry | Burst 2 (9 Months) | 1.79 oz eq | Standard Deviation 1.56 |
| Usual Diet Plus Self-Care (Comparison Arm) | Self-reported Diet Components and Food Groups: Poultry | Burst 1 (Baseline) | 1.89 oz eq | Standard Deviation 1.64 |
| Usual Diet Plus Self-Care (Comparison Arm) | Self-reported Diet Components and Food Groups: Poultry | Burst 2 (9 Months) | 1.82 oz eq | Standard Deviation 1.54 |
p-value: 0.84195% CI: [-0.41, 0.33]ANCOVA
Secondary
Self-reported Diet Components and Food Groups: Protein
Protein obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Protein from the diet was captured by the PROT variable field within the ASA24. This field represents grams (g) of protein consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.
Time frame: Baseline (Burst 1) and 9 months (Burst 2)
Population: Missing data: MHD, Burst 1 (N=1); MHD, Burst 2 (N=19). Comparison, Burst 1 (N=0); Comparison, Burst 2, (N=22).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anti-inflammatory Dietary Intervention (MHD Arm) | Self-reported Diet Components and Food Groups: Protein | Burst 1 (Baseline) | 73.92 g | Standard Deviation 27.21 |
| Anti-inflammatory Dietary Intervention (MHD Arm) | Self-reported Diet Components and Food Groups: Protein | Burst 2 (9 Months) | 73.42 g | Standard Deviation 24.5 |
| Usual Diet Plus Self-Care (Comparison Arm) | Self-reported Diet Components and Food Groups: Protein | Burst 1 (Baseline) | 73.31 g | Standard Deviation 23.62 |
| Usual Diet Plus Self-Care (Comparison Arm) | Self-reported Diet Components and Food Groups: Protein | Burst 2 (9 Months) | 70.09 g | Standard Deviation 27.31 |
p-value: 0.24595% CI: [-2.23, 8.75]ANCOVA
Secondary
Self-reported Diet Components and Food Groups: Retinol
Retinol obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Retinol from the diet was captured by the RET variable field within the ASA24. This field represents micrograms (mcg) of Retinol consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.
Time frame: Baseline (Burst 1) and 9 months (Burst 2)
Population: Missing data: MHD, Burst 1, (N=1); MHD, Burst 2 (N=19). Comparison, Burst 1 (N=0); Comparison, Burst 2 (N=22).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anti-inflammatory Dietary Intervention (MHD Arm) | Self-reported Diet Components and Food Groups: Retinol | Burst 1 (Baseline) | 327.45 mcg | Standard Deviation 210.72 |
| Anti-inflammatory Dietary Intervention (MHD Arm) | Self-reported Diet Components and Food Groups: Retinol | Burst 2 (9 Months) | 302.99 mcg | Standard Deviation 181.71 |
| Usual Diet Plus Self-Care (Comparison Arm) | Self-reported Diet Components and Food Groups: Retinol | Burst 1 (Baseline) | 317.48 mcg | Standard Deviation 190.29 |
| Usual Diet Plus Self-Care (Comparison Arm) | Self-reported Diet Components and Food Groups: Retinol | Burst 2 (9 Months) | 318.97 mcg | Standard Deviation 210.58 |
p-value: 0.49395% CI: [-60.66, 29.19]ANCOVA
Secondary
Self-reported Diet Components and Food Groups: Seafood High in n-3 Fatty Acids
Seafood high in n-3 fatty acids obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Seafood high in n-3 fatty acids from the diet was captured by the M\_FISH\_HI variable field within the ASA24. This field represents ounce equivalents (oz eq) of Seafood high in n-3 fatty acids consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.
Time frame: Baseline (Burst 1) and 9 months (Burst 2)
Population: Missing data: MHD, Burst 1, (N=1); MHD, Burst 2 (N=19). Comparison, Burst 1 (N=0); Comparison, Burst 2 (N=22).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anti-inflammatory Dietary Intervention (MHD Arm) | Self-reported Diet Components and Food Groups: Seafood High in n-3 Fatty Acids | Burst 1 (Baseline) | 0.58 oz eq | Standard Deviation 0.94 |
| Anti-inflammatory Dietary Intervention (MHD Arm) | Self-reported Diet Components and Food Groups: Seafood High in n-3 Fatty Acids | Burst 2 (9 Months) | 0.56 oz eq | Standard Deviation 1.06 |
| Usual Diet Plus Self-Care (Comparison Arm) | Self-reported Diet Components and Food Groups: Seafood High in n-3 Fatty Acids | Burst 1 (Baseline) | 0.44 oz eq | Standard Deviation 0.92 |
| Usual Diet Plus Self-Care (Comparison Arm) | Self-reported Diet Components and Food Groups: Seafood High in n-3 Fatty Acids | Burst 2 (9 Months) | 0.44 oz eq | Standard Deviation 0.9 |
p-value: 0.54195% CI: [-0.16, 0.31]ANCOVA
Secondary
Self-reported Diet Components and Food Groups: Solid Fats
Solid fats obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Solid fats from the diet was captured by the DISCFAT\_SOL variable field within the ASA24. This field represents grams (g) of solid fats consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.
Time frame: Baseline (Burst 1) and 9 months (Burst 2)
Population: Missing data: MHD, Burst 1, (N=1); MHD, Burst 2 (N=19). Comparison, Burst 1 (N=0); Comparison, Burst 2 (N=22).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anti-inflammatory Dietary Intervention (MHD Arm) | Self-reported Diet Components and Food Groups: Solid Fats | Burst 1 (Baseline) | 26.84 g | Standard Deviation 15.44 |
| Anti-inflammatory Dietary Intervention (MHD Arm) | Self-reported Diet Components and Food Groups: Solid Fats | Burst 2 (9 Months) | 23.14 g | Standard Deviation 15.44 |
| Usual Diet Plus Self-Care (Comparison Arm) | Self-reported Diet Components and Food Groups: Solid Fats | Burst 1 (Baseline) | 26.77 g | Standard Deviation 14.68 |
| Usual Diet Plus Self-Care (Comparison Arm) | Self-reported Diet Components and Food Groups: Solid Fats | Burst 2 (9 Months) | 26.93 g | Standard Deviation 14.48 |
p-value: 0.01995% CI: [-6.44, 0.59]ANCOVA
Secondary
Self-reported Diet Components and Food Groups: Total Fats
Total fats obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Total fats from the diet, which consisted of total saturated fatty acids, total monounsaturated fatty acids, and total polyunsaturated fatty acids, was captured by the TFAT variable field within the ASA24. This field represents grams (g) of total fats consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.
Time frame: Baseline (Burst 1) and 9 months (Burst 2)
Population: Missing data: MHD, Burst 1, (N=1); MHD, Burst 2 (N=19). Comparison, Burst 1 (N=0); Comparison, Burst 2 (N=22).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anti-inflammatory Dietary Intervention (MHD Arm) | Self-reported Diet Components and Food Groups: Total Fats | Burst 1 (Baseline) | 67.3 g | Standard Deviation 26.52 |
| Anti-inflammatory Dietary Intervention (MHD Arm) | Self-reported Diet Components and Food Groups: Total Fats | Burst 2 (9 Months) | 65.69 g | Standard Deviation 29.13 |
| Usual Diet Plus Self-Care (Comparison Arm) | Self-reported Diet Components and Food Groups: Total Fats | Burst 1 (Baseline) | 66.71 g | Standard Deviation 25.45 |
| Usual Diet Plus Self-Care (Comparison Arm) | Self-reported Diet Components and Food Groups: Total Fats | Burst 2 (9 Months) | 66.77 g | Standard Deviation 25.4 |
p-value: 0.63595% CI: [-6.95, 4.24]ANCOVA
Secondary
Self-reported Diet Components and Food Groups: Total Folate From Food
Total Folate from food obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Total Folate from food was captured by the FF variable field within the ASA24. This field represents micrograms (mcg) of total folate from food consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.
Time frame: Baseline (Burst 1) and 9 months (Burst 2)
Population: Missing data: MHD, Burst 1, (N=1); MHD, Burst 2 (N=19). Comparison, Burst 1 (N=0); Comparison, Burst 2 (N=22).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anti-inflammatory Dietary Intervention (MHD Arm) | Self-reported Diet Components and Food Groups: Total Folate From Food | Burst 1 (Baseline) | 199.05 mcg | Standard Deviation 93.83 |
| Anti-inflammatory Dietary Intervention (MHD Arm) | Self-reported Diet Components and Food Groups: Total Folate From Food | Burst 2 (9 Months) | 224.17 mcg | Standard Deviation 110.14 |
| Usual Diet Plus Self-Care (Comparison Arm) | Self-reported Diet Components and Food Groups: Total Folate From Food | Burst 1 (Baseline) | 197.56 mcg | Standard Deviation 93.23 |
| Usual Diet Plus Self-Care (Comparison Arm) | Self-reported Diet Components and Food Groups: Total Folate From Food | Burst 2 (9 Months) | 181.69 mcg | Standard Deviation 83.24 |
p-value: <0.00195% CI: [21.47, 61.96]ANCOVA
Secondary
Self-reported Diet Components and Food Groups: Total Intact Fruits + Fruit Juices
Total Intact fruits and fruit juices obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Total Intact fruit and fruit juice consumption from the diet was captured by the F\_TOTAL variable field within the ASA24. This field represents total fruit consumption in cup equivalents (cup eq). Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.
Time frame: Baseline (Burst 1) and 9 months (Burst 2)
Population: Missing data: MHD, Burst 1, (N=1); MHD, Burst 2 (N=19). Comparison, Burst 1 (N=0); Comparison, Burst 2 (N=22).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anti-inflammatory Dietary Intervention (MHD Arm) | Self-reported Diet Components and Food Groups: Total Intact Fruits + Fruit Juices | Burst 1 (Baseline) | 0.85 cup eq | Standard Deviation 0.91 |
| Anti-inflammatory Dietary Intervention (MHD Arm) | Self-reported Diet Components and Food Groups: Total Intact Fruits + Fruit Juices | Burst 2 (9 Months) | 0.95 cup eq | Standard Deviation 0.92 |
| Usual Diet Plus Self-Care (Comparison Arm) | Self-reported Diet Components and Food Groups: Total Intact Fruits + Fruit Juices | Burst 1 (Baseline) | 0.77 cup eq | Standard Deviation 0.78 |
| Usual Diet Plus Self-Care (Comparison Arm) | Self-reported Diet Components and Food Groups: Total Intact Fruits + Fruit Juices | Burst 2 (9 Months) | 0.68 cup eq | Standard Deviation 0.76 |
p-value: 0.03295% CI: [0.02, 0.4]ANCOVA
Secondary
Self-reported Diet Components and Food Groups: Total Moisture
Total Moisture obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Total moisture from diet was captured by the MOIS variable field within the ASA24. This field is quantified in grams (g) of water. Possible results values are limited to values \> 0 (i.e., positive values). Basic descriptive statistics were used to summarize data by arm.ASA-2018 and 2020
Time frame: Baseline (Burst 1) and 9 months (Burst 2)
Population: Missing data: MHD, Burst 1, (N=1); MHD, Burst 2 (N=19). Comparison, Burst 1 (N=0); Comparison, Burst 2 (N=22).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anti-inflammatory Dietary Intervention (MHD Arm) | Self-reported Diet Components and Food Groups: Total Moisture | Burst 1 (Baseline) | 1821 g | Standard Deviation 840 |
| Anti-inflammatory Dietary Intervention (MHD Arm) | Self-reported Diet Components and Food Groups: Total Moisture | Burst 2 (9 Months) | 1943 g | Standard Deviation 959 |
| Usual Diet Plus Self-Care (Comparison Arm) | Self-reported Diet Components and Food Groups: Total Moisture | Burst 1 (Baseline) | 1812 g | Standard Deviation 791 |
| Usual Diet Plus Self-Care (Comparison Arm) | Self-reported Diet Components and Food Groups: Total Moisture | Burst 2 (9 Months) | 1790 g | Standard Deviation 815 |
p-value: 0.10195% CI: [-27.7, 317.6]ANCOVA
Secondary
Self-reported Diet Components and Food Groups: Vitamin B-12
Vitamin B-12 obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Vitamin B-12 was captured by the VB12 variable field within the ASA24. This field represents micrograms (mcg) of Vitamin B-12 consumed (including supplemental sources). Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.
Time frame: Baseline (Burst 1) and 9 months (Burst 2)
Population: Missing data: MHD, Burst 1, (N=1); MHD, Burst 2 (N=19). Comparison, Burst 1 (N=0); Comparison, Burst 2 (N=22).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anti-inflammatory Dietary Intervention (MHD Arm) | Self-reported Diet Components and Food Groups: Vitamin B-12 | Burst 1 (Baseline) | 4.25 mcg | Standard Deviation 2.59 |
| Anti-inflammatory Dietary Intervention (MHD Arm) | Self-reported Diet Components and Food Groups: Vitamin B-12 | Burst 2 (9 Months) | 4.18 mcg | Standard Deviation 2.63 |
| Usual Diet Plus Self-Care (Comparison Arm) | Self-reported Diet Components and Food Groups: Vitamin B-12 | Burst 1 (Baseline) | 4.21 mcg | Standard Deviation 2.64 |
| Usual Diet Plus Self-Care (Comparison Arm) | Self-reported Diet Components and Food Groups: Vitamin B-12 | Burst 2 (9 Months) | 4.06 mcg | Standard Deviation 2.43 |
p-value: 0.84795% CI: [-0.53, 0.64]ANCOVA
Secondary
Self-reported Diet Components and Food Groups: Whole Grains
Whole grains consumed as part of participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Whole grains information from the diet was captured by the G\_WHOLE variable field within the ASA24. This field represents ounce equivalents (oz eq) of whole grains consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.
Time frame: Baseline (Burst 1) and 9 months (Burst 2)
Population: Missing data: MHD, Burst 1, (N=1); MHD, Burst 2 (N=19). Comparison, Burst 1 (N=0); Comparison, Burst 2 (N=22).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anti-inflammatory Dietary Intervention (MHD Arm) | Self-reported Diet Components and Food Groups: Whole Grains | Burst 1 (Baseline) | 0.75 oz eq | Standard Deviation 0.76 |
| Anti-inflammatory Dietary Intervention (MHD Arm) | Self-reported Diet Components and Food Groups: Whole Grains | Burst 2 (9 Months) | 1.06 oz eq | Standard Deviation 1.17 |
| Usual Diet Plus Self-Care (Comparison Arm) | Self-reported Diet Components and Food Groups: Whole Grains | Burst 1 (Baseline) | 0.85 oz eq | Standard Deviation 0.93 |
| Usual Diet Plus Self-Care (Comparison Arm) | Self-reported Diet Components and Food Groups: Whole Grains | Burst 2 (9 Months) | 0.90 oz eq | Standard Deviation 1.01 |
p-value: 0.22395% CI: [-0.1, 0.43]ANCOVA
Secondary
Serum Sodium
Serum specimens were collected and processed at Baseline and 9-months follow-up and shipped to University of Minnesota ARDL laboratory for analysis on Roche Cobas 8000 Chemistry Analyzer. Mean serum sodium levels are summarized by study arm and reported in mmol/L. Reference range is 136-145 mmol/L and the lower LOD is 80 mmol/L. Decreased serum sodium levels from baseline may indicate dehydration.
Time frame: Baseline (Burst 1) and 9 months (Burst 2)
Population: Missing data: Burst 1, MHD: (N=10); Burst 1, Comparison: (N=7). Burst 2, MHD: (N=33); Burst 2, Comparison: (N=40)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anti-inflammatory Dietary Intervention (MHD Arm) | Serum Sodium | Burst 1 (Baseline) | 139.88 mmol/L | Standard Deviation 1.88 |
| Anti-inflammatory Dietary Intervention (MHD Arm) | Serum Sodium | Burst 2 (9 Months) | 140.24 mmol/L | Standard Deviation 2.4 |
| Usual Diet Plus Self-Care (Comparison Arm) | Serum Sodium | Burst 1 (Baseline) | 139.89 mmol/L | Standard Deviation 1.91 |
| Usual Diet Plus Self-Care (Comparison Arm) | Serum Sodium | Burst 2 (9 Months) | 140.11 mmol/L | Standard Deviation 1.99 |
p-value: 0.52195% CI: [-0.37, 0.73]ANCOVA
Secondary
Symbol Search Task Performance
Symbol Search Task Performance is an ambulatory cognitive assessment of processing speed/attention. The task is administered 5 times daily throughout each 7-day measurement Burst (Baseline, 9 months, 18 months, 27 months). Mean response time in milliseconds (ms) for accurate trials will be determined and reported. Possible values ranges for Symbol Search Task Performance are \>0 ms (i.e., positive values). Lower Symbol Search Task Performance values in mean response time are indicative of improvement in cognitive processing.
Time frame: Baseline (Burst 1), and 9 months (Burst 2), 18 months (Burst 3), and 27 months (Burst 4) post-intervention
Population: Missing data: MHD, Burst 1, (N=4); MHD, Burst 2 (N=29); MHD, Burst 3 (N=24); MHD, Burst 4 (N=20). Comparison, Burst 1 (N=0); Comparison, Burst 2 (N=31); Comparison, Burst 3 (N=34); Comparison, Burst 4 (N=15).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anti-inflammatory Dietary Intervention (MHD Arm) | Symbol Search Task Performance | Burst 1 (Baseline) | 1,874.7 ms | Standard Deviation 474.3 |
| Anti-inflammatory Dietary Intervention (MHD Arm) | Symbol Search Task Performance | Burst 2 (9 months) | 1,854.4 ms | Standard Deviation 537.5 |
| Anti-inflammatory Dietary Intervention (MHD Arm) | Symbol Search Task Performance | Burst 3 (18 months) | 1,845.0 ms | Standard Deviation 465.6 |
| Anti-inflammatory Dietary Intervention (MHD Arm) | Symbol Search Task Performance | Burst 4 (27 months) | 1,765.2 ms | Standard Deviation 529.3 |
| Usual Diet Plus Self-Care (Comparison Arm) | Symbol Search Task Performance | Burst 4 (27 months) | 1,812.0 ms | Standard Deviation 445 |
| Usual Diet Plus Self-Care (Comparison Arm) | Symbol Search Task Performance | Burst 1 (Baseline) | 1,846.4 ms | Standard Deviation 466.3 |
| Usual Diet Plus Self-Care (Comparison Arm) | Symbol Search Task Performance | Burst 3 (18 months) | 1,825.6 ms | Standard Deviation 470.7 |
| Usual Diet Plus Self-Care (Comparison Arm) | Symbol Search Task Performance | Burst 2 (9 months) | 1,800.5 ms | Standard Deviation 457.8 |
p-value: 0.03195% CI: [-31, -1.5]Mixed Models Analysis
Secondary
Total Serum Folate Levels
Blood sera specimens were collected and processed at Baseline and 9-months post-intervention and shipped to University of Minnesota Advanced Research & Diagnostic Laboratory (ARDL) for total folate analysis by a validated serum folate assay. Mean total folate levels are summarized by study arm and reported in nmol/L. The lower limit of detection (LLOD) for mean total folate is 4.54 nmol/L and the upper limit of detection (ULOD) 90.8 nmol/L. Increase in this biomarker from baseline for MHD participants indicates possible adherence to an MHD dietary pattern such as eating more green leafy vegetables.
Time frame: Baseline (Burst 1) and 9 months (Burst 2)
Population: Missing data: Burst 1, MHD (N=13); Burst 1, Comparison (N=12). Burst 2, MHD (N=36), Burst 2, Comparison (N=44).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anti-inflammatory Dietary Intervention (MHD Arm) | Total Serum Folate Levels | Burst 1 (Baseline) | 35.93 nmol/L | Standard Deviation 17.19 |
| Anti-inflammatory Dietary Intervention (MHD Arm) | Total Serum Folate Levels | Burst 2 (9 months) | 35.26 nmol/L | Standard Deviation 17.8 |
| Usual Diet Plus Self-Care (Comparison Arm) | Total Serum Folate Levels | Burst 1 (Baseline) | 34.72 nmol/L | Standard Deviation 15.74 |
| Usual Diet Plus Self-Care (Comparison Arm) | Total Serum Folate Levels | Burst 2 (9 months) | 35.01 nmol/L | Standard Deviation 15.78 |
p-value: 0.90495% CI: [-3.63, 4.11]ANCOVA
Secondary
Vitamin B12 Levels
Blood sera specimens were collected and processed at Baseline and 9-months post-intervention and shipped to University of Minnesota ARDL laboratory for Vitamin B12 analysis by a validated Vitamin B12 assay. Mean Vitamin B12 levels are summarized by study arm and reported in pg/mL. Reference ranges for this biomarker are: 232-1245 pg/mL and LLOD is 100 pg/mL. Increase in this biomarker from baseline for MHD participants indicates possible adherence to an MHD dietary pattern.
Time frame: Baseline (Burst 1) and 9 months (Burst 2)
Population: Missing data: Burst 1, MHD (N=10); Burst 1, Comparison (N=7). Burst 2, MHD (N=33), Burst 2, Comparison (N=40).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anti-inflammatory Dietary Intervention (MHD Arm) | Vitamin B12 Levels | Burst 1 (Baseline) | 736.78 pg/mL | Standard Deviation 513.94 |
| Anti-inflammatory Dietary Intervention (MHD Arm) | Vitamin B12 Levels | Burst 2 (9 Months) | 718.23 pg/mL | Standard Deviation 522.58 |
| Usual Diet Plus Self-Care (Comparison Arm) | Vitamin B12 Levels | Burst 1 (Baseline) | 712.89 pg/mL | Standard Deviation 445.71 |
| Usual Diet Plus Self-Care (Comparison Arm) | Vitamin B12 Levels | Burst 2 (9 Months) | 716.22 pg/mL | Standard Deviation 417.64 |
p-value: 0.97895% CI: [-100.13, 97.4]ANCOVA
Secondary
α-Carotenoid Levels
Blood plasma specimens were collected and processed at Baseline and 9-months post-intervention from a sub-sample and shipped to University of Minnesota ARDL lab for α-carotenoid analysis by an HPLC method. α-Carotenoids were measured with a diode array detector equipped HPLC system. Mean α-carotenoid levels are summarized by study arm and reported in mcg/mL. There are no reference ranges for this biomarker (other than non-negative values). Increase in this biomarker from baseline for MHD participants indicates possible adherence to an MHD dietary pattern.
Time frame: Baseline (Burst 1) and 9 months (Burst 2)
Population: Missing data: Burst 1, MHD (N=7); Burst 1, Comparison (N=6). Burst 2, MHD (N=31), Burst 2, Comparison (N=38).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anti-inflammatory Dietary Intervention (MHD Arm) | α-Carotenoid Levels | Burst 1 (Baseline) | 0.04 mcg/mL | Standard Deviation 0.04 |
| Anti-inflammatory Dietary Intervention (MHD Arm) | α-Carotenoid Levels | Burst 2 (9 Months) | 0.04 mcg/mL | Standard Deviation 0.04 |
| Usual Diet Plus Self-Care (Comparison Arm) | α-Carotenoid Levels | Burst 1 (Baseline) | 0.04 mcg/mL | Standard Deviation 0.03 |
| Usual Diet Plus Self-Care (Comparison Arm) | α-Carotenoid Levels | Burst 2 (9 Months) | 0.04 mcg/mL | Standard Deviation 0.06 |
p-value: 0.76995% CI: [-0.01, 0.01]ANCOVA
Secondary
α-Tocopherol Levels
Blood plasma specimens were collected and processed at Baseline and 9-months post-intervention and shipped to University of Minnesota ARDL for α-tocopherol analysis by an HPLC method. α-Tocopherols were measured with a diode array detector equipped HPLC system. Mean α-tocopherol levels are summarized by study arm and reported in mcg/mL. There are no reference ranges for this biomarker from this laboratory (other than non-negative values). Increase in this biomarker from baseline for MHD participants indicates possible adherence to an MHD dietary pattern.
Time frame: Baseline (Burst 1) and 9 months (Burst 2)
Population: Missing data: Burst 1, MHD (N=7); Burst 1, Comparison (N=6). Burst 2, MHD (N=31), Burst 2, Comparison (N=38).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anti-inflammatory Dietary Intervention (MHD Arm) | α-Tocopherol Levels | Burst 1 (Baseline) | 11.39 mcg/mL | Standard Deviation 3.49 |
| Anti-inflammatory Dietary Intervention (MHD Arm) | α-Tocopherol Levels | Burst 2 (9 Months) | 11.45 mcg/mL | Standard Deviation 3.73 |
| Usual Diet Plus Self-Care (Comparison Arm) | α-Tocopherol Levels | Burst 1 (Baseline) | 11.02 mcg/mL | Standard Deviation 2.94 |
| Usual Diet Plus Self-Care (Comparison Arm) | α-Tocopherol Levels | Burst 2 (9 Months) | 11.26 mcg/mL | Standard Deviation 3.56 |
p-value: 0.72195% CI: [-0.76, 0.52]ANCOVA