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

Sponsor

University of North Carolina, Chapel Hill (Other)

Overall Status

Completed

CT.gov ID

NCT01515098

Collaborator

(none)

123

Enrollment

Location

Arms

37.9

Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mild Cognitive Decline	Dietary Supplement: Freeze-dried blueberries Dietary Supplement: Dextrose Placebo	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

123 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Jan 1, 2012

Actual Primary Completion Date :

Mar 1, 2015

Actual Study Completion Date :

Mar 1, 2015

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Blueberry Group

37 grams of dehydrated blueberries daily for 6 months

Dietary Supplement: Freeze-dried blueberries

Wild blueberries, freeze-dried and pulverized

Placebo Comparator: Placebo Group

37 grams of dextrose powder daily for 6 months

Dietary Supplement: Dextrose Placebo

Placebo developed to closely match blueberry powder.

No Intervention: Reference Group

No intervention

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years to 79 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nutrition Research Institute	Kannapolis	North Carolina	United States	28081

Sponsors and Collaborators

University of North Carolina, Chapel Hill

Investigators

Principal Investigator: Carol L Cheatham, Ph.D., University of North Carolina, Chapel Hill

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Carol Cheatham, PhD, Assistant Professor of Psychology, University of North Carolina, Chapel Hill

ClinicalTrials.gov Identifier:

NCT01515098

Other Study ID Numbers:

11-2075

First Posted:

Jan 23, 2012

Last Update Posted:

Mar 8, 2022

Last Verified:

Mar 1, 2022

Additional relevant MeSH terms:

Cognitive Dysfunction

Study Results

No Results Posted as of Mar 8, 2022