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

Not Applicable

Completed

• Conditions: Cognitive Decline; Nutrition, Healthy; Brain Injuries

• Registration Number: NCT05764824
• Lead Sponsor: Brigham and Women's Hospital

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-01-31
• Study First Submitted QC: 2023-03-10
• Study First Posted: 2023-03-13
• Study Start: 2023-10-01
• Primary Completion: 2024-09-11
• Study Completion: 2024-09-11
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-03
• Last Update Posted: 2024-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in plasma concentration of neurofilament light (NFL) between baseline and 24 weeks	Baseline and at 24 weeks after the intervention	Change will be calculated as difference between plasma NFL concentration measured at 24 weeks and NFL concentration measured at baseline.
Change in plasma concentration of phosphorylated tau (pTau-181) between baseline and 24 weeks	Baseline and at 24 weeks post intervention	Change will be calculated as difference between plasma pTau-181 concentration measured at 24 weeks and plasma concentration of pTau-181 measured at baseline

Secondary Outcome Measures

Name	Time	Method
Change in plasma concentration of glial fibrillary acid protein (GFAB) between baseline and 24 weeks	Baseline and at 24 weeks post intervention	Change will be calculated as difference between plasma concentration of GFAB measured at 24 weeks and plasma GFAB concentration measured at baseline
Change in concentration of serum non-esterified fatty acids (NEFA) between baseline and 24 weeks	Baseline and 24 weeks post intervention	Change will be computed as difference between serum concentration of NEFA measured at 24 weeks and serum NEFA concentration measured at baseline
Change in cognitive battery test score between baseline and 24 weeks post intervention	Baseline and at 24 weeks post intervention	The investigators will use CANTAB (computer-based and interactive software) to complete 8 cognitive battery tests including a) Motor screening task; b) Reaction time; c) Paired associates learning; d) Spatial working memory; e) Pattern recognition memory; f) Delayed matching to sample; g) Rapid visual information processing; and h) Match to sample visual search. The computer automatically calculates a composite score from these 8 tests (a-h) and the investigators will define change in cognitive battery test score as difference in composite score between 24 weeks and baseline.

Trial Locations

Locations (1)

Mass General Brigham; 🇺🇸 Boston, Massachusetts, United States