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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01515098
First Posted: January 23, 2012
Last Update Posted: May 14, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Carol Cheatham, PhD, University of North Carolina, Chapel Hill
  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
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change in cognitive test performance [ Time Frame: Baseline, 90 days, 180 days ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 123
Study Start Date: January 2012
Study Completion Date: March 2015
Primary Completion Date: March 2015 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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


Locations
United States, North Carolina
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
  More Information

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
First Submitted: January 18, 2012
First Posted: January 23, 2012
Last Update Posted: May 14, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders