Nutritional Supplementation in Cognitive Aging

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2011 by University of Cincinnati.
Recruitment status was Recruiting

Sponsor:

Collaborator:

Welch Foods Incorporated

Information provided by:

University of Cincinnati

ClinicalTrials.gov Identifier:

NCT00599508

First received: January 10, 2008

Last updated: March 3, 2011

Last verified: March 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

January 10, 2008

Last Updated Date

March 3, 2011

Start Date ^ICMJE

June 2006

Estimated Primary Completion Date

March 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00599508 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Nutritional Supplementation in Cognitive Aging

Official Title ^ICMJE

Nutritional Supplementation in Cognitive Aging

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Condition ^ICMJE

Age-related Memory Decline

Intervention ^ICMJE

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
Dietary Supplement: placebo juice
several ounces consumed three times a day for 16 weeks; dosage determined according to subject's weight

Study Arm (s)

Experimental: A
purple grape juice.

Intervention: Dietary Supplement: purple grape juice
Placebo Comparator: B
placebo juice

Intervention: Dietary Supplement: placebo juice

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

March 2012

Estimated Primary Completion Date

March 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Mild Cognitive Impairment

Exclusion Criteria:

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

Gender

Both

Ages

66 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Marcelle Shidler, M.A.

513-558-2455

marcelle.shidler@uc.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00599508

Other Study ID Numbers ^ICMJE

06-03-20-08

Has Data Monitoring Committee

Responsible Party

JoLynne Wightman, Welch Foods Incorporated

Study Sponsor ^ICMJE

University of Cincinnati

Collaborators ^ICMJE

Welch Foods Incorporated

Investigators ^ICMJE

Principal Investigator:

Robert Krikorian, Ph.D.

University of Cincinnati

Information Provided By

University of Cincinnati

Verification Date

March 2011

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

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