Nutritional Supplementation in Cognitive Aging

October 7, 2016 updated by: Robert Krikorian, University of Cincinnati
To evaluate the effect of supplemented berry fruit juice and whole fruit berry powder on memory performance and brain function in older adults

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45267-0559
        • University of Cincinnati

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

66 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Mild Cognitive Impairment

Exclusion Criteria:

  • Diabetes
  • Weight of under 100 or over 210 pounds
  • Chronic use of pain medication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: grape juice active intervention
Concord grape juice administered daily for 12 or 16 weeks
Dietary supplement: 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.
Other Names:
  • Welch's Concord Grape Juice
Placebo Comparator: juice placebo
berry placebo juice administered daily for 12 or 16 weeks
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
Active Comparator: blueberry juice active intervention
wild blueberry juice administered daily for 12 weeks
Dietary supplement: blueberry juice
wild blueberry juice administered daily for 12 weeks, dosage determined according to participant's weight
Active Comparator: blueberry powder intervention
whole fruit blueberry powder administered daily for 16 weeks
Dietary supplement: whole fruit blueberry powder
whole fruit, freeze dried blueberry powder derived from a blend of cultivated blueberries administered daily for 16 weeks
Placebo Comparator: powder placebo
placebo powder administered daily for 16 weeks
Dietary supplement: berry placebo powder
berry placebo powder administered daily for 16 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
memory performance
Time Frame: at the end of the intervention
at the end of the intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
cortisol
Time Frame: at the end of the intervention
at the end of the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cincinnati

Collaborators

U.S. Highbush Blueberry Council
Welch Foods Incorporated

Investigators

  • Principal Investigator: Robert Krikorian, Ph.D., University of Cincinnati

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

January 10, 2008

First Submitted That Met QC Criteria

January 10, 2008

First Posted (Estimate)

January 23, 2008

Study Record Updates

Last Update Posted (Estimate)

October 10, 2016

Last Update Submitted That Met QC Criteria

October 7, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 06-03-20-08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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