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Nutritional Supplementation in Cognitive Aging

This study has been completed.
Sponsor:
Collaborators:
Welch Foods Incorporated
U.S. Highbush Blueberry Council
Information provided by (Responsible Party):
Robert Krikorian, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00599508
First received: January 10, 2008
Last updated: October 7, 2016
Last verified: October 2016
  Purpose
To evaluate the effect of supplemented berry fruit juice and whole fruit berry powder on memory performance and brain function in older adults

Condition Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Nutritional Supplementation in Cognitive Aging

Resource links provided by NLM:


Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • memory performance [ Time Frame: at the end of the intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • cortisol [ Time Frame: at the end of the intervention ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: June 2006
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   66 Years and older   (Senior)
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Responsible Party: Robert Krikorian, Clinical Professor, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00599508     History of Changes
Other Study ID Numbers: 06-03-20-08 
Study First Received: January 10, 2008
Last Updated: October 7, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by University of Cincinnati:
memory
aging

ClinicalTrials.gov processed this record on December 09, 2016