Nutritional Supplementation in Cognitive Aging

NCT ID: NCT00599508

Last Updated: 2016-10-10

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

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2015-01-31

Brief Summary

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To evaluate the effect of supplemented berry fruit juice and whole fruit berry powder on memory performance and brain function in older adults

Detailed Description

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Randomized trials involving daily supplementation with berry fruits in older adults with early memory changes. The berry products include Concord grape juice, blueberry juice, and whole fruit blueberry powder. Supplementation periods are 12 and 16 weeks, depending on berry product. The Aims of the studies are to assess effects on cognitive performance and in a subset of participants, in brain activity.

Conditions

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Cognitive Aging

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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grape juice active intervention

Concord grape juice administered daily for 12 or 16 weeks

Group Type ACTIVE_COMPARATOR

Concord grape juice

Intervention Type DIETARY_SUPPLEMENT

Several ounces Concord grape juice administered 3 times a day for 12 or 16 weeks. Specific dosage determined by participant's weight.

juice placebo

berry placebo juice administered daily for 12 or 16 weeks

Group Type PLACEBO_COMPARATOR

placebo juice

Intervention Type DIETARY_SUPPLEMENT

several ounces placebo juice consumed three times a day for 12 or 16 weeks; dosage determined according to participant's weight

blueberry juice active intervention

wild blueberry juice administered daily for 12 weeks

Group Type ACTIVE_COMPARATOR

blueberry juice

Intervention Type DIETARY_SUPPLEMENT

wild blueberry juice administered daily for 12 weeks, dosage determined according to participant's weight

blueberry powder intervention

whole fruit blueberry powder administered daily for 16 weeks

Group Type ACTIVE_COMPARATOR

whole fruit blueberry powder

Intervention Type DIETARY_SUPPLEMENT

whole fruit, freeze dried blueberry powder derived from a blend of cultivated blueberries administered daily for 16 weeks

powder placebo

placebo powder administered daily for 16 weeks

Group Type PLACEBO_COMPARATOR

berry placebo powder

Intervention Type DIETARY_SUPPLEMENT

berry placebo powder administered daily for 16 weeks

Interventions

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Concord grape juice

Several ounces Concord grape juice administered 3 times a day for 12 or 16 weeks. Specific dosage determined by participant's weight.

Intervention Type DIETARY_SUPPLEMENT

placebo juice

several ounces placebo juice consumed three times a day for 12 or 16 weeks; dosage determined according to participant's weight

Intervention Type DIETARY_SUPPLEMENT

blueberry juice

wild blueberry juice administered daily for 12 weeks, dosage determined according to participant's weight

Intervention Type DIETARY_SUPPLEMENT

whole fruit blueberry powder

whole fruit, freeze dried blueberry powder derived from a blend of cultivated blueberries administered daily for 16 weeks

Intervention Type DIETARY_SUPPLEMENT

berry placebo powder

berry placebo powder administered daily for 16 weeks

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Welch's Concord Grape Juice

Eligibility Criteria

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Inclusion Criteria

* Mild Cognitive Impairment

Exclusion Criteria

* Diabetes
* Weight of under 100 or over 210 pounds
* Chronic use of pain medication
Minimum Eligible Age

66 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Welch Foods Incorporated

INDUSTRY

Sponsor Role collaborator

U.S. Highbush Blueberry Council

OTHER

Sponsor Role collaborator

University of Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Robert Krikorian

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert Krikorian, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Locations

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University of Cincinnati

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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06-03-20-08

Identifier Type: -

Identifier Source: org_study_id

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