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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

January 10, 2008
October 7, 2016
June 2006
January 2015   (final data collection date for primary outcome measure)
memory performance [ Time Frame: at the end of the intervention ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00599508 on ClinicalTrials.gov Archive Site
cortisol [ Time Frame: at the end of the intervention ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Nutritional Supplementation in Cognitive Aging
Nutritional Supplementation in Cognitive Aging
To evaluate the effect of supplemented berry fruit juice and whole fruit berry powder on memory performance and brain function in older adults
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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Cognitive Aging
  • 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
  • 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
  • Dietary Supplement: blueberry juice
    wild blueberry juice administered daily for 12 weeks, dosage determined according to participant's weight
  • Dietary Supplement: whole fruit blueberry powder
    whole fruit, freeze dried blueberry powder derived from a blend of cultivated blueberries administered daily for 16 weeks
  • Dietary Supplement: berry placebo powder
    berry placebo powder administered daily for 16 weeks
  • Active Comparator: grape juice active intervention
    Concord grape juice administered daily for 12 or 16 weeks
    Intervention: Dietary Supplement: Concord grape juice
  • Placebo Comparator: juice placebo
    berry placebo juice administered daily for 12 or 16 weeks
    Intervention: Dietary Supplement: placebo juice
  • Active Comparator: blueberry juice active intervention
    wild blueberry juice administered daily for 12 weeks
    Intervention: Dietary Supplement: blueberry juice
  • Active Comparator: blueberry powder intervention
    whole fruit blueberry powder administered daily for 16 weeks
    Intervention: Dietary Supplement: whole fruit blueberry powder
  • Placebo Comparator: powder placebo
    placebo powder administered daily for 16 weeks
    Intervention: Dietary Supplement: berry placebo powder
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
January 2015
January 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Mild Cognitive Impairment

Exclusion Criteria:

  • Diabetes
  • Weight of under 100 or over 210 pounds
  • Chronic use of pain medication
Both
66 Years and older   (Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00599508
06-03-20-08
No
Not Provided
Not Provided
Robert Krikorian, University of Cincinnati
University of Cincinnati
  • Welch Foods Incorporated
  • U.S. Highbush Blueberry Council
Principal Investigator: Robert Krikorian, Ph.D. University of Cincinnati
University of Cincinnati
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP