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

Not Applicable

Completed

• Conditions: Mild Cognitive Decline
• Interventions: Dietary Supplement: Dextrose Placebo; Dietary Supplement: Freeze-dried blueberries

• Registration Number: NCT01515098
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-18
• Study First Submitted QC: 2012-01-20
• Study First Posted: 2012-01-23
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-06
• Last Update Posted: 2022-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

Inclusion Criteria

• Men and women age 65 and older
• BMI between 18.5 and 34.5
• Close individual to report memory decline

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Group	Dextrose Placebo	37 grams of dextrose powder daily for 6 months
Blueberry Group	Freeze-dried blueberries	37 grams of dehydrated blueberries daily for 6 months

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Nutrition Research Institute; 🇺🇸 Kannapolis, North Carolina, United States