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

Primary Purpose

Mild Cognitive Decline

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Freeze-dried blueberries
Dextrose Placebo
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mild Cognitive Decline

Eligibility Criteria

65 Years - 79 Years (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Nutrition Research Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

No Intervention

Arm Label

Blueberry Group

Placebo Group

Reference Group

Arm Description

37 grams of dehydrated blueberries daily for 6 months

37 grams of dextrose powder daily for 6 months

No intervention

Outcomes

Primary Outcome Measures

Change in cognitive test performance
Measured by CANTAB
Change in brain activity (N200, P300) related to cognitive abilities as measured by event-related potentials (ERP)
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
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
Oxidative stress and inflammatory markers will be measured in blood and compared between baseline and outcome.

Full Information

First Posted
January 18, 2012
Last Updated
March 6, 2022
Sponsor
University of North Carolina, Chapel Hill
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1. Study Identification

Unique Protocol Identification Number
NCT01515098
Brief Title
Effect of Blueberries on Cognition and Body Composition in Elderly With Mild Cognitive Decline
Acronym
BERRY
Official Title
The Effect of Blueberry Consumption on Cognition and Body Composition in Elderly Who Are Experiencing Mild Cognitive Decline
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of North Carolina, Chapel Hill

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Decline

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
123 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Blueberry Group
Arm Type
Experimental
Arm Description
37 grams of dehydrated blueberries daily for 6 months
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
37 grams of dextrose powder daily for 6 months
Arm Title
Reference Group
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
Freeze-dried blueberries
Intervention Description
Wild blueberries, freeze-dried and pulverized
Intervention Type
Dietary Supplement
Intervention Name(s)
Dextrose Placebo
Intervention Description
Placebo developed to closely match blueberry powder.
Primary Outcome Measure Information:
Title
Change in cognitive test performance
Description
Measured by CANTAB
Time Frame
Baseline, 180 days
Title
Change in brain activity (N200, P300) related to cognitive abilities as measured by event-related potentials (ERP)
Description
Recognition memory, speed of processing, and memory consolidation as measured by the electrophysiological technique known as event-related potentials (ERP)
Time Frame
Baseline, 180 days
Secondary Outcome Measure Information:
Title
Change in body mass distribution
Description
DXA scans to measure body composition at baseline and outcome will be compared for differences
Time Frame
Baseline, 180 days
Title
Change in oxidative stress and inflammatory markers as measured in blood and urine
Description
Oxidative stress and inflammatory markers will be measured in blood and compared between baseline and outcome.
Time Frame
Baseline, 180 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carol L Cheatham, Ph.D.
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nutrition Research Institute
City
Kannapolis
State/Province
North Carolina
ZIP/Postal Code
28081
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
36066009
Citation
Cheatham CL, Canipe LG 3rd, Millsap G, Stegall JM, Chai SC, Sheppard KW, Lila MA. Six-month intervention with wild blueberries improved speed of processing in mild cognitive decline: a double-blind, placebo-controlled, randomized clinical trial. Nutr Neurosci. 2023 Oct;26(10):1019-1033. doi: 10.1080/1028415X.2022.2117475. Epub 2022 Sep 6.
Results Reference
derived
PubMed Identifier
29523147
Citation
Sheppard KW, Cheatham CL. Omega-6/omega-3 fatty acid intake of children and older adults in the U.S.: dietary intake in comparison to current dietary recommendations and the Healthy Eating Index. Lipids Health Dis. 2018 Mar 9;17(1):43. doi: 10.1186/s12944-018-0693-9.
Results Reference
derived

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

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