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Nutritional Supplementation in Cognitive Aging

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ClinicalTrials.gov Identifier: NCT00599508
Recruitment Status : Completed
First Posted : January 23, 2008
Last Update Posted : October 10, 2016
Sponsor:
Collaborators:
Welch Foods Incorporated
U.S. Highbush Blueberry Council
Information provided by (Responsible Party):
Robert Krikorian, University of Cincinnati

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

Condition or disease Intervention/treatment Phase
Cognitive Aging Dietary Supplement: Concord grape juice Dietary Supplement: placebo juice Dietary Supplement: blueberry juice Dietary Supplement: whole fruit blueberry powder Dietary Supplement: berry placebo powder Not Applicable

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  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Nutritional Supplementation in Cognitive Aging
Study Start Date : June 2006
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: 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



Primary Outcome Measures :
  1. memory performance [ Time Frame: at the end of the intervention ]

Secondary Outcome Measures :
  1. cortisol [ Time Frame: at the end of the intervention ]


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Ages Eligible for Study:   66 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mild Cognitive Impairment

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00599508


Locations
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267-0559
Sponsors and Collaborators
University of Cincinnati
Welch Foods Incorporated
U.S. Highbush Blueberry Council
Investigators
Principal Investigator: Robert Krikorian, Ph.D. University of Cincinnati

Responsible Party: Robert Krikorian, Clinical Professor, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00599508     History of Changes
Other Study ID Numbers: 06-03-20-08
First Posted: January 23, 2008    Key Record Dates
Last Update Posted: October 10, 2016
Last Verified: October 2016

Keywords provided by Robert Krikorian, University of Cincinnati:
memory
aging