NCT05937165

Brief Summary

This randomized, cross-over, pilot study aims to compare preliminary impact of a standard dose of blueberry powder (24 g) vs a higher dose (48 g) on the bioavailability of flavonoids and inflammatory biomarkers in older adults with minor levels of depressive symptoms.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 10, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

October 31, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2024

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

December 15, 2025

Completed
Last Updated

December 15, 2025

Status Verified

December 1, 2025

Enrollment Period

1.1 years

First QC Date

June 29, 2023

Results QC Date

November 24, 2025

Last Update Submit

December 11, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Urinary Flavonoid Biomarkers

    Change in total flavonoid metabolites found in the urine. The values for the metabolites represent the relative abundance of each metabolite, rather than absolute quantification, with higher values reflecting higher levels of total flavonoid metabolites in the urine.

    Baseline and Day 3 of intervention

  • Inflammatory Biomarker C-reactive Protein

    Change in serum C-reactive Protein

    Baseline and Day 3 of intervention

Secondary Outcomes (3)

  • Inflammatory Biomarker Tumor Necrosis Factor Alpha

    Baseline and Day 3 of intervention

  • Inflammatory Biomarker Interleukin 6

    Baseline and Day 3 of intervention

  • Inflammatory Biomarker Interferon Gamma

    Baseline and Day 3 of intervention

Study Arms (2)

Standard Dose Freeze-dried Blueberry Powder

ACTIVE COMPARATOR

Consumption of 24 g of freeze dried blueberry powder for 3 consecutive days.

Other: Freeze-dried Blueberry Powder

Higher Dose Freeze-dried Blueberry Powder

EXPERIMENTAL

Consumption of 48 g of freeze dried blueberry powder for 3 consecutive days.

Other: Freeze-dried Blueberry Powder

Interventions

Three day consumption of two doses of freeze-dried blueberry powder

Higher Dose Freeze-dried Blueberry PowderStandard Dose Freeze-dried Blueberry Powder

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Men and women aged 65 years and older
  • Minor levels of depressive symptoms (center for epidemiological studies depression scale, ≥4 and \<16 points)

You may not qualify if:

  • Unwilling to follow the study protocol
  • Cognitive impairment (assessed via the telephone Montreal Cognitive Assessment) defined as individuals scoring \<19)
  • Self-reporting a history of major depression, bipolar, schizophrenia, or other psychotic or neurologic disorders
  • Self-reporting of history gastro-intestinal diseases/conditions e.g., of bowel resection, inflammatory bowel disease/syndrome, Celiac disease
  • Self-reporting immune disorders, e.g., rheumatoid arthritis, cancer, and other immunocompromising conditions
  • Self-reporting history of type 1 or type 2 diabetes
  • Self-reporting any history of substance or alcohol use disorder
  • Allergy to blueberries
  • Self-reporting use of anti-inflammatory (e.g., fish oil or non-steroidal anti-inflammatory drugs) or immune-suppressant drugs
  • Are excessive tea or coffee consumers (e.g., \>3 cups/day)
  • Recent and consistent use of antibiotics
  • Currently taking or advised during the intervention to take anti-depressants
  • Current homicidal or suicidal ideation (assessed via the P4 Suicidality Screener
  • All deviations must be approved by the study sponsor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hebrew Rehabilitation Center

Roslindale, Massachusetts, 02131, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Limitations and Caveats

This data is used as hypothesis generating, and is a very small sample size. Interpret the results with caution. The data for interferon-gamma is delayed due to the assay kit being back-ordered. We hope to submit these results by January 2026.

Results Point of Contact

Title
Courtney Millar
Organization
Hebrew SeniorLife, Marcus Institute of Aging, Harvard Medical School

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2023

First Posted

July 10, 2023

Study Start

October 31, 2023

Primary Completion

November 25, 2024

Study Completion

November 25, 2024

Last Updated

December 15, 2025

Results First Posted

December 15, 2025

Record last verified: 2025-12

Locations