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

This study is currently recruiting participants.
Verified March 2014 by University of North Carolina, Chapel Hill
Sponsor:
Information provided by (Responsible Party):
Carol Cheatham, PhD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01515098
First received: January 18, 2012
Last updated: March 7, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Mild Cognitive Decline
Dietary Supplement: Freeze-dried blueberries
Dietary Supplement: Dextrose Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: The Effect of Blueberry Consumption on Cognition and Body Composition in Elderly Who Are Experiencing Mild Cognitive Decline

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Change in cognitive test performance [ Time Frame: Baseline, 90 days, 180 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in body mass distribution [ Time Frame: Baseline, 180 days ] [ Designated as safety issue: No ]
  • Change in oxidative stress and inflammatory markers as measured in blood and urine [ Time Frame: Baseline, 90 days, 180 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 132
Study Start Date: January 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   65 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01515098

Contacts
Contact: Carol L Cheatham, Ph.D. 704-250-5010 carol_cheatham@unc.edu

Locations
United States, North Carolina
Nutrition Research Institute Recruiting
Kannapolis, North Carolina, United States, 28081
Principal Investigator: Carol L Cheatham, Ph.D.         
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Carol L Cheatham, Ph.D. University of North Carolina, Chapel Hill
  More Information

No publications provided

Responsible Party: Carol Cheatham, PhD, Assistant Professor of Psychology, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01515098     History of Changes
Other Study ID Numbers: 11-2075
Study First Received: January 18, 2012
Last Updated: March 7, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 16, 2014