Dietary Intervention Targeting Inflammation, Motivation, and Engagement in Physical Activity in Sedentary, Older Adults With Depressive Symptoms
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Depressive Symptoms
- Sponsor
- Hebrew SeniorLife
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- Change in Engagement in Physical Activity
- Status
- Completed
- Last Updated
- 9 months ago
Overview
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.
Investigators
Courtney Millar
Assistant Scientist I
Hebrew SeniorLife
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Change in Engagement in Physical Activity
Time Frame: 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 Outcomes
- Change in Inflammatory Marker - Interleukin-6(Change between Baseline and 12 week follow-up)
- Change in Inflammatory Marker - Brain Derived Neurotrophic Factor(Change between Baseline and 12 week follow-up)
- Study Recruitment Feasibility(Through study completion, approximately 6 months)
- Change in Motivation(Change between baseline and 12 week follow-up)
- Change in Inflammatory Marker - C-Reactive Protein(Change between Baseline and 12 week follow-up.)