Effect of Blueberries on Cognition and Body Composition in Elderly With Mild Cognitive Decline (BERRY)
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|ClinicalTrials.gov Identifier: NCT01515098|
Recruitment Status : Completed
First Posted : January 23, 2012
Last Update Posted : May 14, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Mild Cognitive Decline||Dietary Supplement: Freeze-dried blueberries Dietary Supplement: Dextrose Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||123 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||The Effect of Blueberry Consumption on Cognition and Body Composition in Elderly Who Are Experiencing Mild Cognitive Decline|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||March 2015|
|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|
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|