Effect of Blueberries on Cognition and Body Composition in Elderly With Mild Cognitive Decline

Study Overview
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Brief Summary
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Purpose: The purpose of this study is to examine the effect of blueberry consumption on cognitive decline and body composition in humans. Hypothesis 1: Adults with mild cognitive decline who consume blueberries will experience an improvement in cognitive abilities as measured by a standardized battery of tests, relative to those who consume a placebo. Hypothesis 2: Adults with mild cognitive decline who consume blueberries will evidence an increase in processing speed and an improvement in memory abilities as measured in an electrophysiological paradigm and compared to those who consume a placebo. Hypothesis 3: Daily intake of 35 g freeze-dried blueberries will improve body composition (fat mass vs. lean mass). Hypothesis 4: Daily intake of 35 g freeze-dried blueberries will decrease oxidative stress and inflammatory markers.

Official Title
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The Effect of Blueberry Consumption on Cognition and Body Composition in Elderly Who Are Experiencing Mild Cognitive Decline

Conditions
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Mild Cognitive Decline

Intervention / Treatment
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* Dietary Supplement: Freeze-dried blueberries
* Dietary Supplement: Dextrose Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women age 65 and older BMI between 18.5 and 34.5 Close individual to report memory decline Exclusion Criteria: History of central nervous system or psychiatric disorders Dementia or Alzheimer's diagnosis Diabetes Smoking >20 cigarettes/day Gastrointestinal/digestive disorders Uncontrolled chronic disease

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 79 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Blueberry Group<br>37 grams of dehydrated blueberries daily for 6 months | Dietary Supplement: Freeze-dried blueberries<br>* Wild blueberries, freeze-dried and pulverized<br>|
| Placebo Comparator: Placebo Group<br>37 grams of dextrose powder daily for 6 months | Dietary Supplement: Dextrose Placebo<br>* Placebo developed to closely match blueberry powder.<br>|
| No Intervention: Reference Group<br>No intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cognitive test performance | Measured by CANTAB | Baseline, 180 days | 
| Change in brain activity (N200, P300) related to cognitive abilities as measured by event-related potentials (ERP) | Recognition memory, speed of processing, and memory consolidation as measured by the electrophysiological technique known as event-related potentials (ERP) | Baseline, 180 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body mass distribution | DXA scans to measure body composition at baseline and outcome will be compared for differences | Baseline, 180 days | 
| Change in oxidative stress and inflammatory markers as measured in blood and urine | Oxidative stress and inflammatory markers will be measured in blood and compared between baseline and outcome. | Baseline, 180 days |