Nutritional Supplementation in Cognitive Aging

NCT00599508 | Completed

• 1 other identifier: 06-03-20-08
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cognitive Aging

Keywords

memory; aging

Outcome Measures

Primary Outcomes (1)

• memory performance

  at the end of the intervention

Secondary Outcomes (1)

• cortisol

  at the end of the intervention

Study Arms (5)

grape juice active intervention

ACTIVE COMPARATOR

Concord grape juice administered daily for 12 or 16 weeks

Dietary Supplement: Concord grape juice

juice placebo

PLACEBO COMPARATOR

berry placebo juice administered daily for 12 or 16 weeks

Dietary Supplement: placebo juice

blueberry juice active intervention

ACTIVE COMPARATOR

wild blueberry juice administered daily for 12 weeks

Dietary Supplement: blueberry juice

blueberry powder intervention

ACTIVE COMPARATOR

whole fruit blueberry powder administered daily for 16 weeks

Dietary Supplement: whole fruit blueberry powder

powder placebo

PLACEBO COMPARATOR

placebo powder administered daily for 16 weeks

Dietary Supplement: berry placebo powder

Interventions

Concord grape juice DIETARY_SUPPLEMENT

Several ounces Concord grape juice administered 3 times a day for 12 or 16 weeks. Specific dosage determined by participant's weight.

Also known as: Welch's Concord Grape Juice

grape juice active intervention

placebo juice DIETARY_SUPPLEMENT

several ounces placebo juice consumed three times a day for 12 or 16 weeks; dosage determined according to participant's weight

juice placebo

blueberry juice DIETARY_SUPPLEMENT

wild blueberry juice administered daily for 12 weeks, dosage determined according to participant's weight

blueberry juice active intervention

whole fruit blueberry powder DIETARY_SUPPLEMENT

whole fruit, freeze dried blueberry powder derived from a blend of cultivated blueberries administered daily for 16 weeks

blueberry powder intervention

berry placebo powder DIETARY_SUPPLEMENT

berry placebo powder administered daily for 16 weeks

powder placebo

Eligibility Criteria

• Age: 66 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Mild Cognitive Impairment

You may not qualify if:

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

Sponsors & Collaborators

• University of Cincinnati: lead
• Welch Foods Incorporated: collaborator
• U.S. Highbush Blueberry Council: collaborator

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45267-0559, United States

Location

Study Officials

• Robert Krikorian, Ph.D.

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 10, 2008
• First Posted: January 23, 2008
• Study Start: June 1, 2006
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: October 10, 2016

Record last verified: 2016-10

Locations

US (1)