Blueberries, Inflammation, Motivation, and Physical Activity
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 proved 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Freeze-dried Blueberry Powder Randomized participants will be asked to consume 48 grams of freeze-dried blueberry powder each day for 12 weeks. |
Other: 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.
|
| Placebo Comparator: 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. |
Other: 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.
|
Outcome Measures
Primary Outcome Measures
- Engagement in Physical Activity [Up to 12 weeks]
Defined as median daily-step count over intervention
Secondary Outcome Measures
- 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)
- Motivation [Up to 12 weeks]
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).
- Inflammatory Marker - C-Reactive protein [C-reactive protein (mg/dL) will be measured in blood collected from participants.]
Up to 12 weeks
- Inflammatory Marker - Interleukin-6 [Interleukin-6 (pg/mL) will be measured in blood collected from participants.]
Up to 12 weeks
- Inflammatory Marker - Brain derived neurotrophic factor [Brain derived neurotrophic (pg/mL) factor will be measured in blood collected from participants.]
Up to 12 weeks
Eligibility Criteria
Criteria
Inclusion Criteria:
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Men and women aged ≥65 years
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Self-reporting ≥ 8 hours of sitting per/day (e.g., sedentary behavior)
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Depressive symptoms (defined as ≥4 and <16 points on the center for epidemiological studies depression-scale)
Exclusion Criteria:
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Unwilling to follow the study protocol
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Self-reporting usual engagement in activities that have a metabolic equivalents (MET) ≥3 (e.g., dancing, jogging, tennis, brisk walking) as defined by the Community Healthy Activities Model Program for Seniors (CHAMPS) Physical Activity Questionnaire for Older Adults
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Cognitive impairment (defined as Montreal Cognitive Assessment, MoCA <22 points)
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Self-reporting a history of inflammatory bowel disease/syndrome, major depression, bipolar, schizophrenia, or other psychotic disorders
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Allergic to intervention or control products
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Recent use (within the last 3 months) of antibiotics
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Current substance use disorder (Drug Abuse Screening Test, DAST-10>2 points)
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Current alcohol use disorder (Alcohol Use Disorders Identification Test - Consumption, AUDIT-C≥4 points)
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Currently taking or advised during the intervention to take anti-depressants
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Current homicidal or suicidal ideation (assessed via the P4 Suicidality Screener)
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Current psychosis (via the Psychosis and Hallucinations Questionnaire, PHQ>12 points)
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Manic symptoms (assessed by the Mood Disorder Questionnaire, MDQ >5 points)
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Hebrew SeniorLife
Investigators
- Principal Investigator: Courtney Millar, PhD, Hebrew SeniorLife, Marcus Institute of Aging, Harvard Medical Schools
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Pro00064749