Depressive Symptoms
Conditions
Keywords
Anthocyanins, Fiber, Aging
Brief summary
The purpose of this study is to determine the feasibility and preliminary efficacy of daily supplementation of freeze-dried blueberry to modulate inflammation-driven lack of motivation in 40 sedentary, older adults with depressive symptoms.
Detailed description
The investigators will conduct a 14 week, single-site, randomized, double-blind, parallel pilot study in 40 sedentary, older adults with depressive symptoms. Participants will first enter a 2-week washout period where they will avoid consumption of foods high in fiber and anthocyanins (e.g., blueberries) and will also be wearing an activity monitor. Participants will then be randomized to consume either 48 g of freeze-dried blueberry powder (\ 600 mg of anthocyanins and \ 8 g of fiber) or 48 g of a nutritionally matched placebo powder (devoid of anthocyanins and fiber) each day for a total of 12 weeks. At baseline, participants will be undergo assessments for mood/well-being, relevant symptoms, motivation to engage in physical activity, and provide a blood sample for the evaluation of inflammatory biomarkers. For the entire duration of the study, participants will continue to wear the activity monitor. After 4, 6, 8 and 12 weeks of consuming the powder there will be study visits that assess mood/well-being, relevant symptoms, motivation to engage in physical activity and compliance with the intervention. Additionally, a blood sample for the evaluation of inflammatory makers will be taken after 6 and 12 weeks of the intervention.
Interventions
Participants will be asked to consume 48 grams of freeze-dried blueberry powder (\ equivalent to 2 cups of fresh blueberries) daily for 12 weeks. Participants will be asked to save any powder packet wrappers as a means to measure compliance. They will also be instructed to avoid consumption of foods/beverages that are high in anthocyanins and/or fiber.
OTHERPlacebo Powder
Participants will be asked to consume 48 grams of a nutritionally matched placebo powder (that does not contain fiber or anthocyanins) daily for 12 weeks. Participants will be asked to save any powder packet wrappers as a means to measure compliance. They will also be instructed to avoid consumption of foods/beverages that are high in anthocyanins and/or fiber.
Sponsors
Hebrew SeniorLife
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men and women aged ≥65 years * Self-reporting ≥ 8 hours of sitting per/day (e.g., sedentary behavior) * Depressive symptoms (defined as ≥4 and \<16 points on the center for epidemiological studies depression-scale)
Exclusion criteria
* Unwilling to follow the study protocol * A median daily step count \>7,500 steps per day (as measured by the ActiGraph), or per discretion of the PI * Cognitive impairment (defined as Montreal Cognitive Assessment, MoCA \<22 points) * Self-reporting a history of inflammatory bowel disease/syndrome, major depression, bipolar, schizophrenia, or other psychotic disorders, or per discretion of the PI * Self-reporting type 1 or type 2 diabetes * Allergic to intervention or control products * Recent use (within the last 3 months) of antibiotics, or per discretion of the PI * Recent use (within the last 3 months) of pro-biotics, or per discretion of the PI * Current substance use disorder (Drug Abuse Screening Test, DAST-10\>2 points) * Current alcohol use disorder (Alcohol Use Disorders Identification Test - Consumption, AUDIT-C≥4 points) * Unstable anti-depressant use (e.g., change in medication within last 3-6 months), or per discretion of the PI * Current homicidal or suicidal ideation (assessed via the P4 Suicidality Screener) * Current psychosis (via the Psychosis and Hallucinations Questionnaire, PHQ\>12 points) * Manic symptoms (assessed by the Mood Disorder Questionnaire, MDQ \>5 points)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Engagement in Physical Activity | Change between baseline and 12 week follow-up | Defined as change between an approximate 2-week median daily-step count prior to baseline and prior to 12 week follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Study Recruitment Feasibility | Through study completion, approximately 6 months | Participant retention (e.g., the number of participants that complete the intervention out of all participants randomized to an intervention arm) |
| Change in Motivation | Change between baseline and 12 week follow-up | Motivation to engage in physical activity will be assessed via self-report questionnaire, Motives for Physical Activities Measure-Revised (range 0-30 points, with higher scores indicating higher levels of motivation). |
| Change in Inflammatory Marker - C-Reactive Protein | Change between Baseline and 12 week follow-up. | C-reactive protein (mg/L) will be measured in blood collected from participants. |
| Change in Inflammatory Marker - Interleukin-6 | Change between Baseline and 12 week follow-up | Interleukin-6 (pg/mL) will be measured in blood collected from participants. If values were above the standard curve in the ELISA kit (n= 2 samples), then the highest standard concentration was used as the value. |
| Change in Inflammatory Marker - Brain Derived Neurotrophic Factor | Change between Baseline and 12 week follow-up | Brain derived neurotrophic (ng/mL) factor will be measured in blood collected from participants. |
Countries
United States
Participant flow
Recruitment details
Our original goal was to recruit 40 individuals. However, recruitment was challenging and we ultimately enrolled 33 individuals. Of the 33 individuals that signed the consent form, there were 4 individuals who either did not follow the study protocol (n=2) or were lost to follow-p (n=2) before completing the baseline visit/randomization. Thus, a total of 29 individuals were enrolled and randomized.
Participants by arm
| Arm | Count |
|---|---|
| Freeze-dried Blueberry Powder Randomized participants will be asked to consume 48 grams of freeze-dried blueberry powder each day for 12 weeks.
Freeze-dried Blueberry Powder: Participants will be asked to consume 48 grams of freeze-dried blueberry powder (\
equivalent to 2 cups of fresh blueberries) daily for 12 weeks. Participants will be asked to save any powder packet wrappers as a means to measure compliance. They will also be instructed to avoid consumption of foods/beverages that are high in anthocyanins and/or fiber. | 15 |
| Placebo Powder Randomized participants will be asked to consume 48 grams of a nutritionally matched placebo powder devoid of fiber and anthocyanins each day for 12 weeks.
Placebo Powder: Participants will be asked to consume 48 grams of a nutritionally matched placebo powder (that does not contain fiber or anthocyanins) daily for 12 weeks. Participants will be asked to save any powder packet wrappers as a means to measure compliance. They will also be instructed to avoid consumption of foods/beverages that are high in anthocyanins and/or fiber. | 14 |
| Total | 29 |
Baseline characteristics
| Characteristic | Total | Freeze-dried Blueberry Powder | Placebo Powder |
|---|---|---|---|
| Age, Continuous | 72 years STANDARD_DEVIATION 5 | 71 years STANDARD_DEVIATION 4 | 73 years STANDARD_DEVIATION 5 |
| Center for Epidemiological Scale for Depression (CESD) | 8 scores on a scale STANDARD_DEVIATION 4 | 8 scores on a scale STANDARD_DEVIATION 4 | 8 scores on a scale STANDARD_DEVIATION 4 |
| Height | 1.6 meters STANDARD_DEVIATION 0.1 | 1.6 meters STANDARD_DEVIATION 0.1 | 1.6 meters STANDARD_DEVIATION 0.1 |
| Median Step Count | 6103 steps per day STANDARD_DEVIATION 1282 | 5916 steps per day STANDARD_DEVIATION 1257 | 6302 steps per day STANDARD_DEVIATION 1325 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 27 Participants | 13 Participants | 14 Participants |
| Region of Enrollment United States | 29 participants | 15 participants | 14 participants |
| Sex: Female, Male Female | 23 Participants | 11 Participants | 12 Participants |
| Sex: Female, Male Male | 6 Participants | 4 Participants | 2 Participants |
| Weight | 81.0 kilograms STANDARD_DEVIATION 18 | 81.4 kilograms STANDARD_DEVIATION 23 | 80.5 kilograms STANDARD_DEVIATION 12.8 |
| Years of Education 13-15 years | 4 Participants | 3 Participants | 1 Participants |
| Years of Education 16-18 years | 23 Participants | 12 Participants | 11 Participants |
| Years of Education 19 or more years | 2 Participants | 0 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 14 |
| other Total, other adverse events | 4 / 15 | 4 / 14 |
| serious Total, serious adverse events | 0 / 15 | 0 / 14 |
Outcome results
Primary
Change in Engagement in Physical Activity
Defined as change between an approximate 2-week median daily-step count prior to baseline and prior to 12 week follow-up
Time frame: Change between baseline and 12 week follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Freeze-dried Blueberry Powder | Change in Engagement in Physical Activity | 318 steps per day | Standard Deviation 1778 |
| Placebo Powder | Change in Engagement in Physical Activity | 346 steps per day | Standard Deviation 624 |
Secondary
Change in Inflammatory Marker - Brain Derived Neurotrophic Factor
Brain derived neurotrophic (ng/mL) factor will be measured in blood collected from participants.
Time frame: Change between Baseline and 12 week follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Freeze-dried Blueberry Powder | Change in Inflammatory Marker - Brain Derived Neurotrophic Factor | 1.258 nanograms/mL | Standard Deviation 10.038 |
| Placebo Powder | Change in Inflammatory Marker - Brain Derived Neurotrophic Factor | -1.226 nanograms/mL | Standard Deviation 12.116 |
Secondary
Change in Inflammatory Marker - C-Reactive Protein
C-reactive protein (mg/L) will be measured in blood collected from participants.
Time frame: Change between Baseline and 12 week follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Freeze-dried Blueberry Powder | Change in Inflammatory Marker - C-Reactive Protein | 0.6 miligrams/liter | Standard Deviation 2.6 |
| Placebo Powder | Change in Inflammatory Marker - C-Reactive Protein | -1.6 miligrams/liter | Standard Deviation 4.9 |
Secondary
Change in Inflammatory Marker - Interleukin-6
Interleukin-6 (pg/mL) will be measured in blood collected from participants. If values were above the standard curve in the ELISA kit (n= 2 samples), then the highest standard concentration was used as the value.
Time frame: Change between Baseline and 12 week follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Freeze-dried Blueberry Powder | Change in Inflammatory Marker - Interleukin-6 | -0.5 picograms/mililiter | Standard Deviation 1.2 |
| Placebo Powder | Change in Inflammatory Marker - Interleukin-6 | -0.7 picograms/mililiter | Standard Deviation 2.6 |
Secondary
Change in Motivation
Motivation to engage in physical activity will be assessed via self-report questionnaire, Motives for Physical Activities Measure-Revised (range 0-30 points, with higher scores indicating higher levels of motivation).
Time frame: Change between baseline and 12 week follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Freeze-dried Blueberry Powder | Change in Motivation | 4 score on a scale | Standard Deviation 18 |
| Placebo Powder | Change in Motivation | 0 score on a scale | Standard Deviation 12 |
Secondary
Study Recruitment Feasibility
Participant retention (e.g., the number of participants that complete the intervention out of all participants randomized to an intervention arm)
Time frame: Through study completion, approximately 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Freeze-dried Blueberry Powder | Study Recruitment Feasibility | 12 Participants |
| Placebo Powder | Study Recruitment Feasibility | 10 Participants |