Nutritional Supplementation in Cognitive Aging

This study is ongoing, but not recruiting participants.
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: August 1, 2014
Last verified: August 2014
  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 2014 (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
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
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: August 1, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Cincinnati:
memory
aging

ClinicalTrials.gov processed this record on August 18, 2014