Long-term Effects of Blueberry Supplementation on Brain Health in Older Adults

NCT ID: NCT05764824

Last Updated: 2024-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2024-09-11

Brief Summary

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This study will test whether consuming blueberry powder 20g/d for 24 weeks can improve memory and other cognitive function and alter serum biomarkers of brain injury among older adults.

Detailed Description

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In a randomized, double-blind placebo, controlled design, the investigators will test the effects of 20 g/d of blueberry powder for 24 weeks on cognitive function and serum biomarkers of brain injury among older adults.

Conditions

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Cognitive Decline Nutrition, Healthy Brain Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Blueberry group

Blueberry arm

Group Type ACTIVE_COMPARATOR

Blueberry powder

Intervention Type DIETARY_SUPPLEMENT

20 g per day of blueberry powder

Control group

Control arm

Group Type PLACEBO_COMPARATOR

Controlled and matched powder

Intervention Type OTHER

20 g per day

Interventions

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Blueberry powder

20 g per day of blueberry powder

Intervention Type DIETARY_SUPPLEMENT

Controlled and matched powder

20 g per day

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adults aged 65-99 years
* Able to travel to Brigham and Women's Hospital for 4 clinic visits

Exclusion Criteria

* Known allergies to blueberries
* Unable to abstain from blueberry consumption during the study period
* Inability to provide informed consent
* Planned major surgery during study period or recent major surgery up to 3 months before recruitment
* Organ transplant
* Plan to move out of greater Boston area during the study period
* Diagnosis of dementia, severe cognitive decline, end-stage renal disease, substance abuse, insulin-dependent diabetes mellitus, major cancer excluding non-melanoma skin cancer, and schizophrenia.
Minimum Eligible Age

65 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Luc Djousse, MD, ScD, MPH

Lead Investigator and Director of Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mass General Brigham

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2022P002554

Identifier Type: -

Identifier Source: org_study_id

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