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OpenTrials
Completed

NCT Number: NCT01515098

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

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.

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Key information

Conditions

Mild Cognitive Decline

Age range

65 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nutrition Research Institute

Kannapolis, North Carolina, 28081, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Freeze-dried blueberries

Dietary Supplement

Wild blueberries, freeze-dried and pulverized

Dextrose Placebo

Dietary Supplement

Placebo developed to closely match blueberry powder.

Primary outcomes

  1. Change in cognitive test performance

    Time frame: Baseline, 180 days

    Measured by CANTAB

  2. Change in brain activity (N200, P300) related to cognitive abilities as measured by event-related potentials (ERP)

    Time frame: Baseline, 180 days

    Recognition memory, speed of processing, and memory consolidation as measured by the electrophysiological technique known as event-related potentials (ERP)

Secondary outcomes

  1. Change in body mass distribution

    Time frame: Baseline, 180 days

    DXA scans to measure body composition at baseline and outcome will be compared for differences

  2. Change in oxidative stress and inflammatory markers as measured in blood and urine

    Time frame: Baseline, 180 days

    Oxidative stress and inflammatory markers will be measured in blood and compared between baseline and outcome.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Official study title

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

Acronym: BERRY

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jan 23, 2012
Registry last updated
Mar 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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