Type 2 Diabetes
Conditions
Keywords
Diet beverages, diet, diabetes control, artificial sweeteners, continuous glucose monitor, gut microbiome, metabolomics
Brief summary
Diet beverages sweetened with artificial sweeteners occupy a unique category in the food environment as they are a source of intensely sweet taste with no calories. Diet beverages are the single largest contributor to artificial sweetener intake in the U.S. diet, and people with diabetes are the highest consumers of diet beverages, tending to consume them as a replacement for dietary sources of sugar, especially in place of sugar-sweetened beverages. This behavior has been endorsed by dietetic and scientific organizations, and diet beverages are marketed as being synonymous with better health, suitable for weight loss, and thus advantageous for diabetes control. The underlying public health concern is that there are few data to support or refute the benefit or harm of habitual diet beverage consumption by people with diabetes; therefore randomized trials with relevant outcomes must be conducted because they would address many limitations of previous research and have major implications for dietary recommendations on diet beverage intake and primary and secondary prevention of chronic disease. To begin addressing this important scientific gap the investigators are testing the effect of diet beverage intake on diabetes control parameters in free-living adults with type 2 diabetes in a randomized, two arm parallel trial with a run-in period of 2-weeks and an active intervention period of 24-weeks. This study will recruit 200 patients with type 2 diabetes who are usual consumers of commercial diet beverages and randomize them to receive and consume either: 1) A commercial diet beverage of choice (3 servings or 24 oz. daily); or 2) Unflavored bottled water of choice (sparkling or plain) (3 servings or 24 oz. daily). The primary outcome will be a central measure of clinical diabetes control in glycated hemoglobin (HbA1c). The study will also measure the nature and magnitude of glycemic excursions via continuous glucose monitors, as well as clinical markers of cardiometabolic risk and kidney function. Lastly, investigators will measure plausible mechanisms whereby diet beverage intake may alter risk by assessing the effect of diet beverage intake on the functional composition of the gut microbiome via stool samples and comprehensive metabolomics, satiety hormones, as well as usual dietary intake, and upstream behavioral pathways which may inform dietary intake patterns.
Interventions
BEHAVIORALDiet Beverage
Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners.
BEHAVIORALWater
Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage. The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling. Participants randomized to consume water will be instructed to avoid intake of diet beverages.
Sponsors
University of Minnesota
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of California, Irvine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
All nursing staff/phlebotomist collecting physical samples, and the lab analyzing the samples will be masked to the trial arm the participant is in. The biostatistician performing the final analyses will also be masked.
Intervention model description
This study is testing the effect of commercial diet beverage intake on diabetes control parameters in free-living adults with type 2 diabetes in a randomized, two arm parallel trial with a run-in period of 2-weeks and an active intervention period of 24-weeks. We will recruit 200 patients with type 2 diabetes who are usual consumers of commercial diet beverages and randomize them to receive and consume either: 1) A commercial diet beverage of choice (3 servings or 24 oz. daily); or 2) Unflavored bottled water of choice (sparkling or plain) (3 servings or 24 oz. daily).
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
Inclusion criteria
We will include men, women and non-binary participants with T2D, age 35 years and older, able to provide informed consent, otherwise healthy, who meet the following criteria: * Physician diagnosed type 2 diabetes ≥ 6 months prior to screening * HbA1c 6.5-8.5% at participant screening * Current treatment with lifestyle changes or stable diabetes-related medication levels for the past 3 months * Willingness to provide consent to contact treating physician and physician agreement to refrain from changing diabetes-related medications during the trial (change defined as \> 2 fold change in dose of any 1 hyperglycemic agent or addition or subtraction of an agent) * No physician-directed medication change for 3 months if prescribed medication for lipids or blood pressure * Usual consumers of diet beverages (≥ 3 servings/ week (24 oz.) and the willingness to maintain fidelity of the intervention, and participate in all aspects of the intervention * Not actively looking to make major lifestyle alterations during the study period with stable weight for 2 months (within 3%).
Exclusion criteria
* Type 1 diabetes or suspected type 1 diabetes (lean with polyuria, polydipsia, and weight loss with little response to metformin) * Secondary diabetes due to specific causes (e.g. monogenic syndromes, pancreatic surgery, and pancreatitis) * Diabetic Ketoacidosis hospitalization within last 6 months * Severe/major hypoglycemia in the last 3 months-severe/major hypoglycemia is defined as a hypoglycemic event in which patient requires assistance of another person to manage the episode * Glucocorticoid use (prednisone 2.5 mg/d or more or its equivalent) * History of intolerance or allergy to diet beverages or AS or phenylketonuria * Any condition that is known to affect the validity of the glycemic measures (Hba1c) * Major cardiovascular disease event or surgery within past 6 months * Gastrointestinal disease * Renal or liver disease * Current treatment for cancer * Those with major surgery planned or history of bariatric surgery * Antibiotic treatment (\> 6 days) within past 6 months * Currently pregnant (via self-report) or planning to become pregnant during study period; \<1 year postpartum and breast feeding * Current participation in another interventional clinical trial * Previous randomization in this study, * Heavy alcohol consumption (on average \>2 drinks/day for women and \>3 drinks/day for men) * Habitual consumer of SSB ≥ 1 serving / day (8 oz.) * Does not drink diet beverages * BMI \< 20.0 kg/m2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | Time 0 (directly after 2-week run-in), 12, 24 weeks | Glycated hemoglobin |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time In Range | All 14 day periods: Run-in (2-weeks, usual-baseline), weeks 11 and 12 (14 days), weeks 23 and 24 (14 days) | Time in range is collected by a masked Continuous Glucose Monitor (CGM), which measures individual glucose levels every 15 minutes for two weeks via a sensor placed on the participants upper arm (underside). Time in Range is defined as the % of time each day with a glucose measure between 70-180 mg/dl. The range of CGM data for inclusion in this study will be 5 to 14 days, consistent with manufacturer's recommendations. |
| Glycemic Variability | All 14 day periods: Run-in (2-weeks, usual-baseline), weeks 11 and 12 (14 days), weeks 23 and 24 (14 days) | Glycemic variability is collected by a masked Continuous Glucose Monitor (CGM), which measures individual glucose levels every 15 minutes for two weeks via a sensor placed on the participants upper arm (underside). Glycemic variability is defined as the Standard Deviation (SD) of the mean glucose during the wear period. The range of CGM data for inclusion in this study will be 5 to 14 days, consistent with manufacturer's recommendations. |
| Mean Glucose (mg/dl) | All 14 day periods: Run-in (2-weeks, usual-baseline), weeks 11 and 12 (14 days), weeks 23 and 24 (14 days) | A measure of the mean, 24 hour glucose concentration calculated across all recorded glucose readings during the wear period |
| Fasting Glucose | Time 0 (directly after 2-week run-in), 12, 24 weeks | Standard (mg/dl) measure taken fasting (morning) during baseline, 12 weeks, 24 weeks |
| Fasting Insulin (Pmol/L) | Time 0 (directly after 2-week run-in), week 12, week 24 | Standard lab measurement for fasting insulin assessment |
| Fructosamine | Time 0 (directly after 2-week run-in),12, 24 weeks | Fructosamine (umol/L) represents usual glycemia over the past 2-3 weeks, and is considered a valid marker of short term clinical glycemic patterns by the American Diabetes Association |
| Weight (kg) | Time 0 (directly after 2-week run-in), 12, 24 weeks | Weight measured on standardized scale in gown |
| Total Cholesterol (mg/dL) | Time 0 (directly after 2-week run-in), 12, 24 weeks | Total cholesterol was measured as part of a lipid panel, a standard measurement for assessing clinical CVD risk |
| Kidney Function | Time 0 (directly after 2-week run-in),12, 24 weeks | eGFR-Cystatin-C (estimated glomerular filtration rate) = mL/min/1.73 m\^2 |
| Systolic Blood Pressure | Time 0 (directly after 2-week run-in),12, 24 weeks | Systolic blood pressure (mmHg) |
| Diastolic Blood Pressure | Time 0 (directly after 2-week run-in), 12, 24 weeks | Standard part of blood pressure measurement (mmHG) |
| Apolipoprotein-AI | Time 0 (directly after 2-week run-in), 12, 24 weeks | Apo-AI the major protein component of high density lipoprotein (HDL) |
| The Diabetes Health Profile (DHP-18) | Time 0 (directly after 2-week run-in), 12, 24 weeks | The Diabetes Health Profile (DHP-18) is used to assess health related quality of life in diabetes across three domains (psychological distress, barriers to activity and disinhibited eating). Each item is scored on a 4-point scale, and the subscale scores are then rescaled to a 0-100 range, with higher scores indicating poorer well-being. |
| Fibrinogen (mg/dL) | Time 0 (directly after 2-week run-in), 12, 24 weeks | A protein involved in forming blood clots in the body |
| C-reactive Protein | Time 0 (directly after 2-week run-in), 12, 24 weeks | biomarker of inflammation |
| Aspartate Aminotransferase (AST) (U/L) | Time 0 (directly after 2-week run-in), 12, 24 weeks | AST (aspartate aminotransferase) is an enzyme that reflects liver function |
| Aminotransferase (ALT) (U/L) | Time 0 (directly after 2-week run-in), 12, 24 weeks | ALT (alanine transaminase) is an enzyme, a protein that reflects liver function |
| Alkaline Phosphatase (ALKPhos ) (U/L) | Time 0 (directly after 2-week run-in), 12, 24 weeks | ALP is an enzyme, a protein, that reflects liver function |
| Thyroid Stimulating Hormone (TSH) | Time 0 (directly after 2-week run-in), 12, 24 weeks | Hormone measured in the blood with energy balance related role |
| Dietary Quality (Healthy Eating Index -HEI) | Run-in period (2 weeks) - baseline, Week 1-12 (period 1), Week 13-24 (period 2). | The Healthy Eating Index (HEI) is a measure of diet quality used to assess how well a set of foods aligns with key recommendations and dietary patterns published in the Dietary Guidelines for Americans (Dietary Guidelines). The overall HEI scores are made up of 13 components that reflect the different food groups and key recommendations in the Dietary Guidelines for Americans. The HEI is scored 0-100 (low to high), with higher scores representing greater reported intake of an overall dietary pattern aligning with USDA Dietary Guidelines. In the SODAS study, dietary intake was assessed by multiple unannounced 24-hour dietary recalls that occurred during the 2-week run-in period to assess usual habits (2 recalls over 2 weeks) and the active intervention (5 recalls over 24 weeks: 2 to 3 recalls during weeks 1-12 (period 1), and 2 to 3 recalls during weeks 13-24 (period 2). to measure any changes in diet quality. Scores during each period represent the average score of recalls. |
| Food Craving Inventory (FCI) | Time 0 (directly after 2-week run-in), 12, 24 weeks | The FCI is a valid and reliable self-report measure of specific food cravings. The inventory consists of 4 factors or subscales measuring cravings for high fats (8 items), carbohydrates/starches (8 items), sweets (8 items), and fast food fats (4 items), and a total score is calculated by summing the subscales. Participants rate each food on a 5-point Likert scale ranging from 0 (never) to 4 (always/almost every day). We calculated the total score by summing the individual item responses in each subscale. Higher scores indicate more frequent cravings of the 28 items. |
| The Pittsburgh Sleep Quality Index (PSQI) | Time 0 (directly after 2-week run-in), 12, 24 weeks | The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a one-month time interval. Each component score of the PSQI ranges from 0 to 3, with 3 indicating the greatest dysfunction or disturbance. The seven component scores are then summed to obtain a global PSQI score, which ranges from 0 to 21. Higher scores indicate poorer sleep quality, with a score greater than 5 suggesting significant sleep difficulties |
| Medication Effect Score (MES) | Time 0 (directly after 2-week run-in), 6, 12, 18, 24 weeks | The medication effect score (MES) is a measure of overall diabetes regimen intensity, and is based on the dosages of medications used and their potencies. The MES is calculated for each diabetes medication in a regimen using the following equation: (actual drug dose/maximum drug dose) × drug-specific adjustment factor. The adjustment factor equates to the expected decrease in HbA1c achieved by the drug as monotherapy. The MES presumes a linear relationship between medication dosage and HbA1c, and the sum of MES values attributed to individual medications represents the maximum A1c reduction that may be expected by the regimen. It is a continuous variable with range 0 (no medications), and the maximum achievable MES is patient specific and dependent on the total number of and dose of medications reported. |
| Therapeutic Intensity Score (TIS) | Time 0 (directly after 2-week run-in), 6, 12, 18, 24 weeks | The therapeutic intensity score (TIS) is a summary measure that accounts for the number of medications and the relative doses a patient received to lower blood pressure. It is a continuous variable with range 0 (no medications), and the maximum achievable TIS is patient specific and dependent on the total number of antihypertensive medications reported. |
| Apolipoprotein B | Time 0 (directly after 2-week run-in), 12, 24 weeks | ApoB levels indicate the atherogenic particle concentration independent of the particle cholesterol content |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Diet Beverage Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners.
Diet Beverage: Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners. | 91 |
| Water Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage. The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling. Participants randomized to consume water will be instructed to avoid intake of diet beverages.
Water: Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage. The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling. Participants randomized to consume water will be instructed to avoid intake of diet beverages. | 90 |
| Total | 181 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 2 |
Baseline characteristics
| Characteristic | Water | Total | Diet Beverage |
|---|---|---|---|
| Age, Continuous | 60.7 years STANDARD_DEVIATION 10.1 | 60.1 years STANDARD_DEVIATION 10.2 | 59.6 years STANDARD_DEVIATION 10.4 |
| Race/Ethnicity, Customized African American or Black | 2 Participants | 6 Participants | 4 Participants |
| Race/Ethnicity, Customized Hispanic/Latino(a) | 11 Participants | 20 Participants | 9 Participants |
| Race/Ethnicity, Customized Other | 10 Participants | 20 Participants | 10 Participants |
| Race/Ethnicity, Customized White (non-Hispanic) | 67 Participants | 135 Participants | 68 Participants |
| Region of Enrollment United States | 90 participants | 181 participants | 91 participants |
| Sex: Female, Male Female | 47 Participants | 94 Participants | 47 Participants |
| Sex: Female, Male Male | 43 Participants | 87 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 91 | 0 / 90 |
| other Total, other adverse events | 0 / 91 | 0 / 90 |
| serious Total, serious adverse events | 0 / 91 | 0 / 90 |
Outcome results
Primary
HbA1c
Glycated hemoglobin
Time frame: Time 0 (directly after 2-week run-in), 12, 24 weeks
Population: Participants analyzed at each time point equals: baseline (all those randomized to arm), 12 weeks (reflects those who were not able to participate in visit with blood draw to to Covid-19 restrictions and dropouts), and 24 weeks (all ASB participants provided data, 87 water participants (2 dropouts/lost to follow up and 1 with sample not able to be analyzed)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diet Beverage | HbA1c | Time 0 | 7.19 Hba1c(%) | Standard Deviation 1.1 |
| Diet Beverage | HbA1c | 12 weeks | 7.13 Hba1c(%) | Standard Deviation 1.02 |
| Diet Beverage | HbA1c | 24 weeks | 7.14 Hba1c(%) | Standard Deviation 1.19 |
| Water | HbA1c | Time 0 | 7.20 Hba1c(%) | Standard Deviation 0.69 |
| Water | HbA1c | 12 weeks | 7.43 Hba1c(%) | Standard Deviation 1.02 |
| Water | HbA1c | 24 weeks | 7.44 Hba1c(%) | Standard Deviation 1.04 |
Secondary
Alkaline Phosphatase (ALKPhos ) (U/L)
ALP is an enzyme, a protein, that reflects liver function
Time frame: Time 0 (directly after 2-week run-in), 12, 24 weeks
Population: Number analyzed at different time points reflects attrition due to data collection, COVID-19 restrictions, and 2 participants who withdrew after baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diet Beverage | Alkaline Phosphatase (ALKPhos ) (U/L) | Week 24 | 88.7 U/L | Standard Deviation 41.9 |
| Diet Beverage | Alkaline Phosphatase (ALKPhos ) (U/L) | Baseline | 88.0 U/L | Standard Deviation 41.8 |
| Diet Beverage | Alkaline Phosphatase (ALKPhos ) (U/L) | Week 12 | 90.1 U/L | Standard Deviation 42.9 |
| Water | Alkaline Phosphatase (ALKPhos ) (U/L) | Week 24 | 83.4 U/L | Standard Deviation 24.6 |
| Water | Alkaline Phosphatase (ALKPhos ) (U/L) | Baseline | 83.3 U/L | Standard Deviation 24.7 |
| Water | Alkaline Phosphatase (ALKPhos ) (U/L) | Week 12 | 82.6 U/L | Standard Deviation 24.5 |
Secondary
Aminotransferase (ALT) (U/L)
ALT (alanine transaminase) is an enzyme, a protein that reflects liver function
Time frame: Time 0 (directly after 2-week run-in), 12, 24 weeks
Population: Number analyzed at different time points reflects attrition due to data collection, COVID-19 restrictions, and 2 participants who withdrew after baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diet Beverage | Aminotransferase (ALT) (U/L) | Week 24 | 26.6 U/L | Standard Deviation 15 |
| Diet Beverage | Aminotransferase (ALT) (U/L) | Week 12 | 26.8 U/L | Standard Deviation 15.8 |
| Diet Beverage | Aminotransferase (ALT) (U/L) | Baseline | 26.6 U/L | Standard Deviation 14.5 |
| Water | Aminotransferase (ALT) (U/L) | Week 12 | 27.1 U/L | Standard Deviation 23.2 |
| Water | Aminotransferase (ALT) (U/L) | Week 24 | 26.3 U/L | Standard Deviation 19 |
| Water | Aminotransferase (ALT) (U/L) | Baseline | 28.2 U/L | Standard Deviation 21.6 |
Secondary
Apolipoprotein-AI
Apo-AI the major protein component of high density lipoprotein (HDL)
Time frame: Time 0 (directly after 2-week run-in), 12, 24 weeks
Population: Number analyzed at different time points reflects attrition due to data collection, COVID-19 restrictions, and 2 participants who withdrew after baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diet Beverage | Apolipoprotein-AI | Baseline | 146.6 mg/dL | Standard Deviation 24.3 |
| Diet Beverage | Apolipoprotein-AI | Week 12 | 148.0 mg/dL | Standard Deviation 25.5 |
| Diet Beverage | Apolipoprotein-AI | Week 24 | 147.2 mg/dL | Standard Deviation 22.5 |
| Water | Apolipoprotein-AI | Baseline | 150.3 mg/dL | Standard Deviation 23.3 |
| Water | Apolipoprotein-AI | Week 12 | 151.0 mg/dL | Standard Deviation 23.7 |
| Water | Apolipoprotein-AI | Week 24 | 152.7 mg/dL | Standard Deviation 24.2 |
Secondary
Apolipoprotein B
ApoB levels indicate the atherogenic particle concentration independent of the particle cholesterol content
Time frame: Time 0 (directly after 2-week run-in), 12, 24 weeks
Population: Number analyzed at different time points reflects attrition due to data collection, COVID-19 restrictions, and 2 participants who withdrew after baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diet Beverage | Apolipoprotein B | Baseline | 88.0 mg/dL | Standard Deviation 21.1 |
| Diet Beverage | Apolipoprotein B | Week 12 | 88.0 mg/dL | Standard Deviation 23.1 |
| Diet Beverage | Apolipoprotein B | Week 24 | 85.4 mg/dL | Standard Deviation 21.3 |
| Water | Apolipoprotein B | Baseline | 85.0 mg/dL | Standard Deviation 24 |
| Water | Apolipoprotein B | Week 12 | 86.6 mg/dL | Standard Deviation 25.1 |
| Water | Apolipoprotein B | Week 24 | 86.8 mg/dL | Standard Deviation 25.8 |
Secondary
Aspartate Aminotransferase (AST) (U/L)
AST (aspartate aminotransferase) is an enzyme that reflects liver function
Time frame: Time 0 (directly after 2-week run-in), 12, 24 weeks
Population: Number analyzed at different time points reflects attrition due to data collection, COVID-19 restrictions, and 2 participants who withdrew after baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diet Beverage | Aspartate Aminotransferase (AST) (U/L) | Baseline | 21.9 U/L | Standard Deviation 9.5 |
| Diet Beverage | Aspartate Aminotransferase (AST) (U/L) | Week 12 | 22.5 U/L | Standard Deviation 11.3 |
| Diet Beverage | Aspartate Aminotransferase (AST) (U/L) | Week 24 | 21.9 U/L | Standard Deviation 8.7 |
| Water | Aspartate Aminotransferase (AST) (U/L) | Baseline | 24.9 U/L | Standard Deviation 15.2 |
| Water | Aspartate Aminotransferase (AST) (U/L) | Week 12 | 23.9 U/L | Standard Deviation 15.4 |
| Water | Aspartate Aminotransferase (AST) (U/L) | Week 24 | 23.9 U/L | Standard Deviation 13 |
Secondary
C-reactive Protein
biomarker of inflammation
Time frame: Time 0 (directly after 2-week run-in), 12, 24 weeks
Population: Number of measurements over time reflect ability to collect data during covid-19 epidemic, participant dropout, and removing 3 outliers (CRP\>30)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diet Beverage | C-reactive Protein | Week 12 | 3.60 mg/L | Standard Deviation 3.81 |
| Diet Beverage | C-reactive Protein | Baseline | 3.93 mg/L | Standard Deviation 3.73 |
| Diet Beverage | C-reactive Protein | Week 24 | 3.85 mg/L | Standard Deviation 4.42 |
| Water | C-reactive Protein | Baseline | 3.54 mg/L | Standard Deviation 3.27 |
| Water | C-reactive Protein | Week 12 | 3.56 mg/L | Standard Deviation 3.12 |
| Water | C-reactive Protein | Week 24 | 3.53 mg/L | Standard Deviation 3.35 |
Secondary
Diastolic Blood Pressure
Standard part of blood pressure measurement (mmHG)
Time frame: Time 0 (directly after 2-week run-in), 12, 24 weeks
Population: Number analyzed at different time points reflects attrition due to data collection, COVID-19 restrictions, and 2 participants who withdrew after baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diet Beverage | Diastolic Blood Pressure | Baseline | 78.5 mmHG | Standard Deviation 7.7 |
| Diet Beverage | Diastolic Blood Pressure | Week 12 | 78.3 mmHG | Standard Deviation 8.4 |
| Diet Beverage | Diastolic Blood Pressure | Week 24 | 77.7 mmHG | Standard Deviation 8.6 |
| Water | Diastolic Blood Pressure | Baseline | 76.6 mmHG | Standard Deviation 7.4 |
| Water | Diastolic Blood Pressure | Week 12 | 75.4 mmHG | Standard Deviation 7.6 |
| Water | Diastolic Blood Pressure | Week 24 | 75.6 mmHG | Standard Deviation 7.2 |
Secondary
Dietary Quality (Healthy Eating Index -HEI)
The Healthy Eating Index (HEI) is a measure of diet quality used to assess how well a set of foods aligns with key recommendations and dietary patterns published in the Dietary Guidelines for Americans (Dietary Guidelines). The overall HEI scores are made up of 13 components that reflect the different food groups and key recommendations in the Dietary Guidelines for Americans. The HEI is scored 0-100 (low to high), with higher scores representing greater reported intake of an overall dietary pattern aligning with USDA Dietary Guidelines. In the SODAS study, dietary intake was assessed by multiple unannounced 24-hour dietary recalls that occurred during the 2-week run-in period to assess usual habits (2 recalls over 2 weeks) and the active intervention (5 recalls over 24 weeks: 2 to 3 recalls during weeks 1-12 (period 1), and 2 to 3 recalls during weeks 13-24 (period 2). to measure any changes in diet quality. Scores during each period represent the average score of recalls.
Time frame: Run-in period (2 weeks) - baseline, Week 1-12 (period 1), Week 13-24 (period 2).
Population: Number analyzed at different time points reflects attrition due to data collection, COVID-19 restrictions, and 2 participants who withdrew after baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diet Beverage | Dietary Quality (Healthy Eating Index -HEI) | Period 1 | 54.8 units on a scale | Standard Deviation 13.2 |
| Diet Beverage | Dietary Quality (Healthy Eating Index -HEI) | Baseline | 54.7 units on a scale | Standard Deviation 12 |
| Diet Beverage | Dietary Quality (Healthy Eating Index -HEI) | Period 2 | 53.3 units on a scale | Standard Deviation 12.3 |
| Water | Dietary Quality (Healthy Eating Index -HEI) | Baseline | 53.7 units on a scale | Standard Deviation 13.6 |
| Water | Dietary Quality (Healthy Eating Index -HEI) | Period 1 | 53.1 units on a scale | Standard Deviation 12.7 |
| Water | Dietary Quality (Healthy Eating Index -HEI) | Period 2 | 51.7 units on a scale | Standard Deviation 13.4 |
Secondary
Fasting Glucose
Standard (mg/dl) measure taken fasting (morning) during baseline, 12 weeks, 24 weeks
Time frame: Time 0 (directly after 2-week run-in), 12, 24 weeks
Population: Number analyzed at different time points reflects attrition due to invalid lab sample, COVID-19 restrictions, and 2 participants who withdrew after baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diet Beverage | Fasting Glucose | Baseline | 147.5 mg/dl | Standard Deviation 40 |
| Diet Beverage | Fasting Glucose | Week 12 | 146.2 mg/dl | Standard Deviation 41.8 |
| Diet Beverage | Fasting Glucose | Week 24 | 149.2 mg/dl | Standard Deviation 44 |
| Water | Fasting Glucose | Baseline | 147.6 mg/dl | Standard Deviation 36.2 |
| Water | Fasting Glucose | Week 12 | 149.3 mg/dl | Standard Deviation 44.2 |
| Water | Fasting Glucose | Week 24 | 153.7 mg/dl | Standard Deviation 51.3 |
Secondary
Fasting Insulin (Pmol/L)
Standard lab measurement for fasting insulin assessment
Time frame: Time 0 (directly after 2-week run-in), week 12, week 24
Population: Number analyzed at different time points reflects attrition due to invalid samples, COVID-19 restrictions, and 2 participants who withdrew after baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diet Beverage | Fasting Insulin (Pmol/L) | Baseline | 128.0 pmol/L | Standard Deviation 97.1 |
| Diet Beverage | Fasting Insulin (Pmol/L) | Week 12 | 135.7 pmol/L | Standard Deviation 141 |
| Diet Beverage | Fasting Insulin (Pmol/L) | Week 24 | 143.5 pmol/L | Standard Deviation 145.4 |
| Water | Fasting Insulin (Pmol/L) | Baseline | 138.5 pmol/L | Standard Deviation 134.1 |
| Water | Fasting Insulin (Pmol/L) | Week 12 | 134.2 pmol/L | Standard Deviation 145 |
| Water | Fasting Insulin (Pmol/L) | Week 24 | 144.2 pmol/L | Standard Deviation 144 |
Secondary
Fibrinogen (mg/dL)
A protein involved in forming blood clots in the body
Time frame: Time 0 (directly after 2-week run-in), 12, 24 weeks
Population: Number analyzed at different time points reflects attrition due to data collection, COVID-19 restrictions, and 2 participants who withdrew after baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diet Beverage | Fibrinogen (mg/dL) | Baseline | 265.0 mg/dL | Standard Deviation 51.9 |
| Diet Beverage | Fibrinogen (mg/dL) | Week 12 | 268.7 mg/dL | Standard Deviation 55.7 |
| Diet Beverage | Fibrinogen (mg/dL) | Week 24 | 270.4 mg/dL | Standard Deviation 53.3 |
| Water | Fibrinogen (mg/dL) | Baseline | 269.3 mg/dL | Standard Deviation 55.1 |
| Water | Fibrinogen (mg/dL) | Week 12 | 263.1 mg/dL | Standard Deviation 50.9 |
| Water | Fibrinogen (mg/dL) | Week 24 | 265.4 mg/dL | Standard Deviation 43.2 |
Secondary
Food Craving Inventory (FCI)
The FCI is a valid and reliable self-report measure of specific food cravings. The inventory consists of 4 factors or subscales measuring cravings for high fats (8 items), carbohydrates/starches (8 items), sweets (8 items), and fast food fats (4 items), and a total score is calculated by summing the subscales. Participants rate each food on a 5-point Likert scale ranging from 0 (never) to 4 (always/almost every day). We calculated the total score by summing the individual item responses in each subscale. Higher scores indicate more frequent cravings of the 28 items.
Time frame: Time 0 (directly after 2-week run-in), 12, 24 weeks
Population: Number analyzed at different time points reflects attrition due to data collection, COVID-19 restrictions, and 2 participants who withdrew after baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diet Beverage | Food Craving Inventory (FCI) | Week 12 | 29.8 units on a scale | Standard Deviation 15.8 |
| Diet Beverage | Food Craving Inventory (FCI) | Baseline | 33.9 units on a scale | Standard Deviation 15.1 |
| Diet Beverage | Food Craving Inventory (FCI) | Week 24 | 27.1 units on a scale | Standard Deviation 15.9 |
| Water | Food Craving Inventory (FCI) | Baseline | 35.4 units on a scale | Standard Deviation 14.8 |
| Water | Food Craving Inventory (FCI) | Week 12 | 30.9 units on a scale | Standard Deviation 15.4 |
| Water | Food Craving Inventory (FCI) | Week 24 | 31.2 units on a scale | Standard Deviation 14.3 |
Secondary
Fructosamine
Fructosamine (umol/L) represents usual glycemia over the past 2-3 weeks, and is considered a valid marker of short term clinical glycemic patterns by the American Diabetes Association
Time frame: Time 0 (directly after 2-week run-in),12, 24 weeks
Population: Number analyzed at different time points reflects attrition due to invalid samples, COVID-19 restrictions, and 2 participants who withdrew after baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diet Beverage | Fructosamine | Baseline | 273.2 umol/L | Standard Deviation 44.8 |
| Diet Beverage | Fructosamine | Week 12 | 272.1 umol/L | Standard Deviation 43.5 |
| Diet Beverage | Fructosamine | Week 24 | 273.0 umol/L | Standard Deviation 51.3 |
| Water | Fructosamine | Baseline | 285.5 umol/L | Standard Deviation 42.4 |
| Water | Fructosamine | Week 12 | 286.6 umol/L | Standard Deviation 47.2 |
| Water | Fructosamine | Week 24 | 291.6 umol/L | Standard Deviation 45.8 |
Secondary
Glycemic Variability
Glycemic variability is collected by a masked Continuous Glucose Monitor (CGM), which measures individual glucose levels every 15 minutes for two weeks via a sensor placed on the participants upper arm (underside). Glycemic variability is defined as the Standard Deviation (SD) of the mean glucose during the wear period. The range of CGM data for inclusion in this study will be 5 to 14 days, consistent with manufacturer's recommendations.
Time frame: All 14 day periods: Run-in (2-weeks, usual-baseline), weeks 11 and 12 (14 days), weeks 23 and 24 (14 days)
Population: Number analyzed at different time points reflects attrition due to device failure, COVID-19 restrictions, and 2 participants who withdrew after baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diet Beverage | Glycemic Variability | Baseline | 39.6 SD of mean glucose (mg/dl) | Standard Deviation 14.7 |
| Diet Beverage | Glycemic Variability | Weeks 11-12 | 40.0 SD of mean glucose (mg/dl) | Standard Deviation 12.9 |
| Diet Beverage | Glycemic Variability | Weeks 23-24 | 40.8 SD of mean glucose (mg/dl) | Standard Deviation 14.9 |
| Water | Glycemic Variability | Baseline | 42.0 SD of mean glucose (mg/dl) | Standard Deviation 13.1 |
| Water | Glycemic Variability | Weeks 11-12 | 44.9 SD of mean glucose (mg/dl) | Standard Deviation 15.4 |
| Water | Glycemic Variability | Weeks 23-24 | 45.8 SD of mean glucose (mg/dl) | Standard Deviation 16.3 |
Secondary
Kidney Function
eGFR-Cystatin-C (estimated glomerular filtration rate) = mL/min/1.73 m\^2
Time frame: Time 0 (directly after 2-week run-in),12, 24 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diet Beverage | Kidney Function | Week 24 | 82.0 eGFR-Cystatin-C (mL/min/1.73 m^2) | Standard Deviation 20.7 |
| Diet Beverage | Kidney Function | Baseline | 83.2 eGFR-Cystatin-C (mL/min/1.73 m^2) | Standard Deviation 21.1 |
| Diet Beverage | Kidney Function | Week 12 | 82.8 eGFR-Cystatin-C (mL/min/1.73 m^2) | Standard Deviation 20.5 |
| Water | Kidney Function | Baseline | 81.5 eGFR-Cystatin-C (mL/min/1.73 m^2) | Standard Deviation 20 |
| Water | Kidney Function | Week 12 | 80.8 eGFR-Cystatin-C (mL/min/1.73 m^2) | Standard Deviation 19.5 |
| Water | Kidney Function | Week 24 | 80.9 eGFR-Cystatin-C (mL/min/1.73 m^2) | Standard Deviation 20.7 |
Secondary
Mean Glucose (mg/dl)
A measure of the mean, 24 hour glucose concentration calculated across all recorded glucose readings during the wear period
Time frame: All 14 day periods: Run-in (2-weeks, usual-baseline), weeks 11 and 12 (14 days), weeks 23 and 24 (14 days)
Population: Number analyzed at different time points reflects attrition due to device failure, COVID-19 restrictions, and 2 participants who withdrew after baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diet Beverage | Mean Glucose (mg/dl) | Baseline | 147.3 mg/dl | Standard Deviation 42.1 |
| Diet Beverage | Mean Glucose (mg/dl) | Weeks 11-12 | 149.4 mg/dl | Standard Deviation 46.4 |
| Diet Beverage | Mean Glucose (mg/dl) | Weeks 23-24 | 153.1 mg/dl | Standard Deviation 50.7 |
| Water | Mean Glucose (mg/dl) | Weeks 23-24 | 162.3 mg/dl | Standard Deviation 47.3 |
| Water | Mean Glucose (mg/dl) | Baseline | 151.4 mg/dl | Standard Deviation 33.1 |
| Water | Mean Glucose (mg/dl) | Weeks 11-12 | 161.2 mg/dl | Standard Deviation 50.5 |
Secondary
Medication Effect Score (MES)
The medication effect score (MES) is a measure of overall diabetes regimen intensity, and is based on the dosages of medications used and their potencies. The MES is calculated for each diabetes medication in a regimen using the following equation: (actual drug dose/maximum drug dose) × drug-specific adjustment factor. The adjustment factor equates to the expected decrease in HbA1c achieved by the drug as monotherapy. The MES presumes a linear relationship between medication dosage and HbA1c, and the sum of MES values attributed to individual medications represents the maximum A1c reduction that may be expected by the regimen. It is a continuous variable with range 0 (no medications), and the maximum achievable MES is patient specific and dependent on the total number of and dose of medications reported.
Time frame: Time 0 (directly after 2-week run-in), 6, 12, 18, 24 weeks
Population: Number analyzed at different time points reflects attrition due to data collection, COVID-19 restrictions, and 2 participants who withdrew after baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diet Beverage | Medication Effect Score (MES) | Week 6 | 1.64 units on a scale | Standard Deviation 1.06 |
| Diet Beverage | Medication Effect Score (MES) | Week 18 | 1.64 units on a scale | Standard Deviation 1.06 |
| Diet Beverage | Medication Effect Score (MES) | Week 12 | 1.63 units on a scale | Standard Deviation 1.05 |
| Diet Beverage | Medication Effect Score (MES) | Week 24 | 1.64 units on a scale | Standard Deviation 1.06 |
| Diet Beverage | Medication Effect Score (MES) | Week 0 | 1.64 units on a scale | Standard Deviation 1.05 |
| Water | Medication Effect Score (MES) | Week 24 | 2.01 units on a scale | Standard Deviation 1.36 |
| Water | Medication Effect Score (MES) | Week 0 | 2.09 units on a scale | Standard Deviation 1.4 |
| Water | Medication Effect Score (MES) | Week 6 | 2.05 units on a scale | Standard Deviation 1.36 |
| Water | Medication Effect Score (MES) | Week 12 | 2.03 units on a scale | Standard Deviation 1.33 |
| Water | Medication Effect Score (MES) | Week 18 | 2.02 units on a scale | Standard Deviation 1.35 |
Secondary
Systolic Blood Pressure
Systolic blood pressure (mmHg)
Time frame: Time 0 (directly after 2-week run-in),12, 24 weeks
Population: Number analyzed at different time points reflects attrition due to data collection, COVID-19 restrictions, and 2 participants who withdrew after baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diet Beverage | Systolic Blood Pressure | Baseline | 136.3 mmHG | Standard Deviation 15 |
| Diet Beverage | Systolic Blood Pressure | Week 12 | 135.5 mmHG | Standard Deviation 14.8 |
| Diet Beverage | Systolic Blood Pressure | Week 24 | 135.6 mmHG | Standard Deviation 15.6 |
| Water | Systolic Blood Pressure | Baseline | 131.9 mmHG | Standard Deviation 15 |
| Water | Systolic Blood Pressure | Week 12 | 129.5 mmHG | Standard Deviation 13.1 |
| Water | Systolic Blood Pressure | Week 24 | 129.6 mmHG | Standard Deviation 14.8 |
Secondary
The Diabetes Health Profile (DHP-18)
The Diabetes Health Profile (DHP-18) is used to assess health related quality of life in diabetes across three domains (psychological distress, barriers to activity and disinhibited eating). Each item is scored on a 4-point scale, and the subscale scores are then rescaled to a 0-100 range, with higher scores indicating poorer well-being.
Time frame: Time 0 (directly after 2-week run-in), 12, 24 weeks
Population: Number analyzed at different time points reflects attrition due to data collection, COVID-19 restrictions, and 2 participants who withdrew after baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diet Beverage | The Diabetes Health Profile (DHP-18) | Baseline | 79.6 units on a scale | Standard Deviation 11.1 |
| Diet Beverage | The Diabetes Health Profile (DHP-18) | Week 24 | 80.6 units on a scale | Standard Deviation 11.1 |
| Diet Beverage | The Diabetes Health Profile (DHP-18) | Week 12 | 79.8 units on a scale | Standard Deviation 9.98 |
| Water | The Diabetes Health Profile (DHP-18) | Week 24 | 78.6 units on a scale | Standard Deviation 11.7 |
| Water | The Diabetes Health Profile (DHP-18) | Baseline | 77.9 units on a scale | Standard Deviation 11.1 |
| Water | The Diabetes Health Profile (DHP-18) | Week 12 | 78.1 units on a scale | Standard Deviation 10.9 |
Secondary
The Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a one-month time interval. Each component score of the PSQI ranges from 0 to 3, with 3 indicating the greatest dysfunction or disturbance. The seven component scores are then summed to obtain a global PSQI score, which ranges from 0 to 21. Higher scores indicate poorer sleep quality, with a score greater than 5 suggesting significant sleep difficulties
Time frame: Time 0 (directly after 2-week run-in), 12, 24 weeks
Population: Number analyzed at different time points reflects attrition due to data collection, COVID-19 restrictions, and 2 participants who withdrew after baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diet Beverage | The Pittsburgh Sleep Quality Index (PSQI) | Baseline | 6.0 units on a scale | Standard Deviation 2.7 |
| Diet Beverage | The Pittsburgh Sleep Quality Index (PSQI) | Week 12 | 6.0 units on a scale | Standard Deviation 3.1 |
| Diet Beverage | The Pittsburgh Sleep Quality Index (PSQI) | Week 24 | 5.9 units on a scale | Standard Deviation 2.9 |
| Water | The Pittsburgh Sleep Quality Index (PSQI) | Baseline | 6.8 units on a scale | Standard Deviation 3 |
| Water | The Pittsburgh Sleep Quality Index (PSQI) | Week 12 | 6.5 units on a scale | Standard Deviation 3.1 |
| Water | The Pittsburgh Sleep Quality Index (PSQI) | Week 24 | 7.1 units on a scale | Standard Deviation 3.2 |
Secondary
Therapeutic Intensity Score (TIS)
The therapeutic intensity score (TIS) is a summary measure that accounts for the number of medications and the relative doses a patient received to lower blood pressure. It is a continuous variable with range 0 (no medications), and the maximum achievable TIS is patient specific and dependent on the total number of antihypertensive medications reported.
Time frame: Time 0 (directly after 2-week run-in), 6, 12, 18, 24 weeks
Population: Number analyzed at different time points reflects attrition due to data collection, COVID-19 restrictions, and 2 participants who withdrew after baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diet Beverage | Therapeutic Intensity Score (TIS) | Week 6 | 0.40 score on a scale | Standard Deviation 0.46 |
| Diet Beverage | Therapeutic Intensity Score (TIS) | Week 18 | 0.41 score on a scale | Standard Deviation 0.49 |
| Diet Beverage | Therapeutic Intensity Score (TIS) | Week 12 | 0.42 score on a scale | Standard Deviation 0.49 |
| Diet Beverage | Therapeutic Intensity Score (TIS) | Week 24 | 0.41 score on a scale | Standard Deviation 0.49 |
| Diet Beverage | Therapeutic Intensity Score (TIS) | Week 0 | 0.41 score on a scale | Standard Deviation 0.51 |
| Water | Therapeutic Intensity Score (TIS) | Week 24 | 0.42 score on a scale | Standard Deviation 0.45 |
| Water | Therapeutic Intensity Score (TIS) | Week 0 | 0.42 score on a scale | Standard Deviation 0.43 |
| Water | Therapeutic Intensity Score (TIS) | Week 6 | 0.41 score on a scale | Standard Deviation 0.43 |
| Water | Therapeutic Intensity Score (TIS) | Week 12 | 0.42 score on a scale | Standard Deviation 0.44 |
| Water | Therapeutic Intensity Score (TIS) | Week 18 | 0.43 score on a scale | Standard Deviation 0.45 |
Secondary
Thyroid Stimulating Hormone (TSH)
Hormone measured in the blood with energy balance related role
Time frame: Time 0 (directly after 2-week run-in), 12, 24 weeks
Population: Number analyzed at different time points reflects attrition due to data collection, COVID-19 restrictions, and 2 participants who withdrew after baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diet Beverage | Thyroid Stimulating Hormone (TSH) | Baseline | 2.45 µU/mL | Standard Deviation 1.58 |
| Diet Beverage | Thyroid Stimulating Hormone (TSH) | Week 12 | 2.65 µU/mL | Standard Deviation 3.32 |
| Diet Beverage | Thyroid Stimulating Hormone (TSH) | Week 24 | 2.36 µU/mL | Standard Deviation 1.66 |
| Water | Thyroid Stimulating Hormone (TSH) | Baseline | 2.17 µU/mL | Standard Deviation 1.34 |
| Water | Thyroid Stimulating Hormone (TSH) | Week 12 | 2.32 µU/mL | Standard Deviation 1.91 |
| Water | Thyroid Stimulating Hormone (TSH) | Week 24 | 2.27 µU/mL | Standard Deviation 1.47 |
Secondary
Time In Range
Time in range is collected by a masked Continuous Glucose Monitor (CGM), which measures individual glucose levels every 15 minutes for two weeks via a sensor placed on the participants upper arm (underside). Time in Range is defined as the % of time each day with a glucose measure between 70-180 mg/dl. The range of CGM data for inclusion in this study will be 5 to 14 days, consistent with manufacturer's recommendations.
Time frame: All 14 day periods: Run-in (2-weeks, usual-baseline), weeks 11 and 12 (14 days), weeks 23 and 24 (14 days)
Population: Number analyzed at different time points reflects attrition due to device failure, COVID-19 restrictions, and 2 participants who withdrew after baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diet Beverage | Time In Range | Baseline | 76.0 % Time in Range | Standard Deviation 19.2 |
| Diet Beverage | Time In Range | Week 11-12 | 75.2 % Time in Range | Standard Deviation 22.6 |
| Diet Beverage | Time In Range | Week 23-24 | 72.8 % Time in Range | Standard Deviation 23.2 |
| Water | Time In Range | Baseline | 72.3 % Time in Range | Standard Deviation 20.9 |
| Water | Time In Range | Week 11-12 | 66.9 % Time in Range | Standard Deviation 26.2 |
| Water | Time In Range | Week 23-24 | 64.7 % Time in Range | Standard Deviation 26.5 |
Secondary
Total Cholesterol (mg/dL)
Total cholesterol was measured as part of a lipid panel, a standard measurement for assessing clinical CVD risk
Time frame: Time 0 (directly after 2-week run-in), 12, 24 weeks
Population: Number analyzed at different time points reflects attrition due to invalid samples, COVID-19 restrictions, and 2 participants who withdrew after baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diet Beverage | Total Cholesterol (mg/dL) | Baseline | 165.9 mg/dl | Standard Deviation 41.3 |
| Diet Beverage | Total Cholesterol (mg/dL) | Week 12 | 164.8 mg/dl | Standard Deviation 39.5 |
| Diet Beverage | Total Cholesterol (mg/dL) | Week 24 | 161.1 mg/dl | Standard Deviation 36.4 |
| Water | Total Cholesterol (mg/dL) | Baseline | 163.6 mg/dl | Standard Deviation 40.9 |
| Water | Total Cholesterol (mg/dL) | Week 12 | 163.6 mg/dl | Standard Deviation 40.3 |
| Water | Total Cholesterol (mg/dL) | Week 24 | 163.4 mg/dl | Standard Deviation 40.1 |
Secondary
Weight (kg)
Weight measured on standardized scale in gown
Time frame: Time 0 (directly after 2-week run-in), 12, 24 weeks
Population: Number analyzed at different time points 2 participants who withdrew after baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diet Beverage | Weight (kg) | Baseline | 102.1 kg | Standard Deviation 21.1 |
| Diet Beverage | Weight (kg) | Week 12 | 101.5 kg | Standard Deviation 20.4 |
| Diet Beverage | Weight (kg) | Week 24 | 101.2 kg | Standard Deviation 20.6 |
| Water | Weight (kg) | Baseline | 96.1 kg | Standard Deviation 21.5 |
| Water | Weight (kg) | Week 12 | 95.8 kg | Standard Deviation 21.8 |
| Water | Weight (kg) | Week 24 | 95.9 kg | Standard Deviation 21.9 |