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

NCT ID: NCT01515098

Last Updated: 2022-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2015-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Mild Cognitive Decline

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Blueberry Group

37 grams of dehydrated blueberries daily for 6 months

Group Type EXPERIMENTAL

Freeze-dried blueberries

Intervention Type DIETARY_SUPPLEMENT

Wild blueberries, freeze-dried and pulverized

Placebo Group

37 grams of dextrose powder daily for 6 months

Group Type PLACEBO_COMPARATOR

Dextrose Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo developed to closely match blueberry powder.

Reference Group

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Freeze-dried blueberries

Wild blueberries, freeze-dried and pulverized

Intervention Type DIETARY_SUPPLEMENT

Dextrose Placebo

Placebo developed to closely match blueberry powder.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Carol Cheatham, PhD

Assistant Professor of Psychology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carol L Cheatham, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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Nutrition Research Institute

Kannapolis, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 36066009 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29523147 (View on PubMed)

Other Identifiers

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11-2075

Identifier Type: -

Identifier Source: org_study_id

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