Effect of Blueberries on Cognition and Body Composition in Elderly With Mild Cognitive Decline (BERRY)
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.
|Mild Cognitive Decline||Dietary Supplement: Freeze-dried blueberries Dietary Supplement: Dextrose Placebo||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
|Official Title:||The Effect of Blueberry Consumption on Cognition and Body Composition in Elderly Who Are Experiencing Mild Cognitive Decline|
- Change in cognitive test performance [ Time Frame: Baseline, 90 days, 180 days ]
- Change in body mass distribution [ Time Frame: Baseline, 180 days ]
- Change in oxidative stress and inflammatory markers as measured in blood and urine [ Time Frame: Baseline, 90 days, 180 days ]
|Study Start Date:||January 2012|
|Study Completion Date:||March 2015|
|Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
|Experimental: Blueberry Group||
Dietary Supplement: Freeze-dried blueberries
Wild blueberries, freeze-dried and pulverized
|Placebo Comparator: Placebo Group||
Dietary Supplement: Dextrose Placebo
Placebo developed to closely match blueberry powder.
|No Intervention: Reference Group|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01515098
|United States, North Carolina|
|Nutrition Research Institute|
|Kannapolis, North Carolina, United States, 28081|
|Principal Investigator:||Carol L Cheatham, Ph.D.||University of North Carolina, Chapel Hill|