Clinical trial NCT05735587: Blueberries, Inflammation, Motivation, and Physical Activity
Official title: Dietary Intervention Targeting Inflammation, Motivation, and Engagement in Physical Activity in Sedentary, Older Adults With Depressive Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Keywords: Anthocyanins
Fiber
Aging
Lead sponsor: Hebrew SeniorLife
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 33
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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)
* 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)

Primary outcomes:
measure: Engagement in Physical Activity
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Study Recruitment Feasibility
timeFrame: Through study completion, approximately 6 months
measure: Motivation
timeFrame: Up to 12 weeks
measure: Inflammatory Marker - C-Reactive protein
timeFrame: C-reactive protein (mg/dL) will be measured in blood collected from participants.
measure: Inflammatory Marker - Interleukin-6
timeFrame: Interleukin-6 (pg/mL) will be measured in blood collected from participants.
measure: Inflammatory Marker - Brain derived neurotrophic factor
timeFrame: Brain derived neurotrophic (pg/mL) factor will be measured in blood collected from participants.
Other outcomes:
Locations:
city: Roslindale
country: United States
facility: Hebrew Rehabilitation Center
state: Massachusetts
Study officials:
affiliation: Hebrew SeniorLife, Marcus Institute of Aging, Harvard Medical Schools
name: Courtney Millar, PhD
role: PRINCIPAL_INVESTIGATOR
References: