Berries, Bugs, and the Blues

NCT05817383 | Completed Results

• 1 other identifier: Pro00068528
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depressive Symptoms

Keywords

Anthocyanins; Fiber; Aging

Outcome Measures

Primary Outcomes (1)

• 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.

  Change between baseline and 12 weeks

Secondary Outcomes (2)

• Abundance Microbes

  Change between baseline and 12 week follow-up

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

  Percent change between baseline and 12 week follow-up

Study Arms (2)

Freeze-dried Blueberry Powder

EXPERIMENTAL

Randomized participants will be asked to consume 48 grams of freeze-dried blueberry powder each day for 12 weeks.

Other: Freeze-dried Blueberry Powder

Placebo Powder

PLACEBO COMPARATOR

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

Interventions

Freeze-dried Blueberry Powder OTHER

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.

Freeze-dried Blueberry Powder

Placebo Powder OTHER

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.

Placebo Powder

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hebrew SeniorLife: lead

Study Sites (1)

Hebrew Rehabilitation Center

Roslindale, Massachusetts, 02131, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Dr. Courtney Millar
• Organization: Hebrew Rehabilitation Center

courtneymillar@hsl.harvard.edu

6179715531

Study Officials

• Courtney Millar, PhD

  Hebrew SeniorLife, Marcus Institute of Aging, Harvard Medical Schools

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Scientist I

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: April 18, 2023
• Study Start: April 5, 2023
• Primary Completion: July 16, 2024
• Study Completion: July 16, 2024
• Last Updated: August 22, 2025
• Results First Posted: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)