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

NCT05764824 | Completed

• 1 other identifier: 2022P002554
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cognitive Decline; Nutrition, Healthy; Brain Injuries

Outcome Measures

Primary Outcomes (2)

• Change in plasma concentration of neurofilament light (NFL) between baseline and 24 weeks

  Change will be calculated as difference between plasma NFL concentration measured at 24 weeks and NFL concentration measured at baseline.

  Baseline and at 24 weeks after the intervention

• Change in plasma concentration of phosphorylated tau (pTau-181) between baseline and 24 weeks

  Change will be calculated as difference between plasma pTau-181 concentration measured at 24 weeks and plasma concentration of pTau-181 measured at baseline

  Baseline and at 24 weeks post intervention

Secondary Outcomes (3)

• Change in plasma concentration of glial fibrillary acid protein (GFAB) between baseline and 24 weeks

  Baseline and at 24 weeks post intervention

• Change in concentration of serum non-esterified fatty acids (NEFA) between baseline and 24 weeks

  Baseline and 24 weeks post intervention

• Change in cognitive battery test score between baseline and 24 weeks post intervention

  Baseline and at 24 weeks post intervention

Study Arms (2)

Blueberry group

ACTIVE COMPARATOR

Blueberry arm

Dietary Supplement: Blueberry powder

Control group

PLACEBO COMPARATOR

Control arm

Other: Controlled and matched powder

Interventions

Blueberry powder DIETARY_SUPPLEMENT

20 g per day of blueberry powder

Blueberry group

Controlled and matched powder OTHER

20 g per day

Control group

Eligibility Criteria

• Age: 65 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Mass General Brigham

Boston, Massachusetts, 02120, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Brain Injuries

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lead Investigator and Director of Research

Study Record Dates

• First Submitted: January 31, 2023
• First Posted: March 13, 2023
• Study Start: October 1, 2023
• Primary Completion: September 11, 2024
• Study Completion: September 11, 2024
• Last Updated: October 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)