Nutritional Supplementation in Cognitive Aging

Cognitive Aging Clinical Trial

Official title:

Nutritional Supplementation in Cognitive Aging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00599508
• Other study ID #: 06-03-20-08
• Status: Completed
• Phase: N/A
• First received: January 10, 2008
• Last updated: October 7, 2016
• Start date: June 2006
• Est. completion date: January 2015

Study information

• Verified date: October 2016
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

To evaluate the effect of supplemented berry fruit juice and whole fruit berry powder on memory performance and brain function in older adults

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 66 Years and older

Eligibility

Inclusion Criteria:

• Mild Cognitive Impairment

Exclusion Criteria:

• Diabetes

• Weight of under 100 or over 210 pounds

• Chronic use of pain medication

Study Design

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

Related Conditions & MeSH terms

• Cognitive Aging

Intervention

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.
• placebo juice
several ounces placebo juice consumed three times a day for 12 or 16 weeks; dosage determined according to participant's weight
• blueberry juice
wild blueberry juice administered daily for 12 weeks, dosage determined according to participant's weight
• whole fruit blueberry powder
whole fruit, freeze dried blueberry powder derived from a blend of cultivated blueberries administered daily for 16 weeks
• berry placebo powder
berry placebo powder administered daily for 16 weeks

Locations

Country	Name	City	State
United States	University of Cincinnati	Cincinnati	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
University of Cincinnati	U.S. Highbush Blueberry Council, Welch Foods Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	memory performance		at the end of the intervention	No
Secondary	cortisol		at the end of the intervention	No