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

Study Overview
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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.

Official Title
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Long-term Effects of Blueberry Supplementation on Brain Health in Older Adults: a Randomized Placebo-controlled Trial

Conditions
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Nutrition, Healthy, Cognitive Decline, Brain Injuries

Intervention / Treatment
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* Dietary Supplement: Blueberry powder
* Other: Controlled and matched powder


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Blueberry group<br>Blueberry arm | Dietary Supplement: Blueberry powder<br>* 20 g per day of blueberry powder<br>|
| Placebo Comparator: Control group<br>Control arm | Other: Controlled and matched powder<br>* 20 g per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in plasma concentration of glial fibrillary acid protein (GFAB) between baseline and 24 weeks | Change will be calculated as difference between plasma concentration of GFAB measured at 24 weeks and plasma GFAB concentration measured at baseline | Baseline and at 24 weeks post intervention | 
| Change in concentration of serum non-esterified fatty acids (NEFA) between baseline and 24 weeks | Change will be computed as difference between serum concentration of NEFA measured at 24 weeks and serum NEFA concentration measured at baseline | Baseline and 24 weeks post intervention | 
| Change in cognitive battery test score between baseline and 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. | Baseline and at 24 weeks post intervention |