Nutritional Supplementation in Cognitive Aging

This study is currently recruiting participants.
Verified December 2013 by University of Cincinnati
Sponsor:
Collaborator:
Welch Foods Incorporated
Information provided by (Responsible Party):
Robert Krikorian, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00599508
First received: January 10, 2008
Last updated: December 27, 2013
Last verified: December 2013
  Purpose

To evaluate the effect of supplemented fruit juice on memory function in older adults


Condition Intervention
Age-related Memory Decline
Dietary Supplement: purple grape juice
Dietary Supplement: placebo juice

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 ]

Estimated Enrollment: 60
Study Start Date: June 2006
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
purple grape juice.
Dietary Supplement: purple grape juice
Several ounces three times a day for 16 weeks. Specific dosage determined by subject's weight.
Other Name: Welch's Concord Grape Juice
Placebo Comparator: B
placebo juice
Dietary Supplement: placebo juice
several ounces consumed three times a day for 16 weeks; dosage determined according to subject's weight

  Eligibility

Ages Eligible for Study:   66 Years and older
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00599508

Contacts
Contact: Marcelle Shidler, M.A. 513-558-2455 marcelle.shidler@uc.edu

Locations
United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45267-0559
Principal Investigator: Robert Krikorian, Ph.D.         
Sponsors and Collaborators
University of Cincinnati
Welch Foods Incorporated
Investigators
Principal Investigator: Robert Krikorian, Ph.D. University of Cincinnati
  More Information

No publications provided

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: December 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Cincinnati:
memory
aging

ClinicalTrials.gov processed this record on April 15, 2014