Berries, Bugs, and the Blues

Hebrew SeniorLife20 enrolled

Overview

This study aims to investigate the impact of daily freeze-dried blueberry powder consumption on the gut microbiota, fecal short chain fatty acids, and depressive symptom severity in 40older, sedentary adults with depressive symptoms.

This study is an ancillary project to a currently funded randomized, placebo-controlled 12-week intervention in older, sedentary adults with depressive symptoms (IRB# Pro00064749). This specific project proposes distinct aims to the trial by gathering preliminary data on the synergistic impact of dietary fiber and anthocyanins (via freeze-dried blueberry powder) on the gut-microbiota, gut-derived metabolites, and depressive symptoms in older adults. 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 depressive symptom severity and provide a fecal sample for gut microbiota and short chain fatty acid measurement. After 4, 8, and 12 weeks of consuming the powder there will be study visits that assess depressive symptom severity. Additionally, a final fecal sample will be taken after 12 weeks of the intervention.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Enrollment

Conditions

Depressive Symptoms

Interventions

Freeze-dried Blueberry PowderOTHER

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 PowderOTHER

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.

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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)

Locations (1)

Hebrew Rehabilitation Center

Roslindale, Massachusetts, United States

Outcomes

Primary Outcomes

Depressive Symptom Severity

Severity of depressive symptoms will be measured before and after the intervention with the Center for Epidemiological Studies Depression Scale-Revised (CESD-R). Scores range from 0 to 60 points, with higher scores indicating more sever depressive symptoms.

Time frame: Change between baseline and 12 weeks

Secondary Outcomes

Abundance Microbes

The abundance of the top 20 most prevalent microbes in our that produce short chain fatty acids (e.g., Bifidobacteria, Eubacterium, and Clostridium) will be evaluated by whole genome sequencing

Time frame: Change between baseline and 12 week follow-up

Fecal Short Chain Fatty Acids (i.e., Butyrate)

The relative abundance of short chain fatty acids (i.e., butyrate ) in feces will be measured using liquid chromatography mass spectrometry.

Time frame: Percent change between baseline and 12 week follow-up

Data from ClinicalTrials.gov

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