Overview

This trial is active, not recruiting.

Conditions obesity, overweight
Treatments active concord grape juice 12 oz per day, placebo grape juice 12 oz per day
Sponsor Boston University
Collaborator Welch's, Inc.
Start date January 2013
End date December 2014
Trial size 60 participants
Trial identifier NCT01775748, H-31937

Summary

The study will compare Concord grape juice to a beverage that contains no grape flavonoids, but has a similar appearance and taste (placebo juice). A total of 60 overweight and obese participants over age 50 will be enrolled. Each participant will drink each beverage for 4 weeks with a 2-week rest period between two beverage consumption periods. The order of beverages (grape juice first or placebo juice first) will be randomized. The investigators will use ultrasound to measure brachial artery flow-mediated dilation, a measure of endothelial vasodilator function. The investigators will also collect blood samples to further assess the cardiovascular effects of grape juice.

The aim of the study is to determine whether Concord grape juice improves endothelial function in patients at risk who do not have cardiovascular disease and may provide information that would guide dietary recommendations. The results may also be used by the sponsor to substantiate claims and labeling of their product.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Arm
(Other)
Active Concord Grape Juice 12 oz per day Placebo Grape Juice 12 oz per day
active concord grape juice 12 oz per day
Grape Juice 12 oz per day
placebo grape juice 12 oz per day
Placebo Grape Juice 12 oz per day
(Other)
Placebo Grape Juice 12 oz per day Active Concord Grape Juice 12 oz per day
active concord grape juice 12 oz per day
Grape Juice 12 oz per day
placebo grape juice 12 oz per day
Placebo Grape Juice 12 oz per day

Primary Outcomes

Measure
Brachial artery flow mediated dilation
time frame: 4 weeks

Secondary Outcomes

Measure
Nitroglycerin-mediated dilation
time frame: 4 weeks
Carotid-Femoral Pulse Wave Velocity
time frame: 4 weeks
Reactive hyperemia
time frame: 4 weeks

Eligibility Criteria

Male or female participants at least 50 years old.

Inclusion Criteria: - Body mass index ≥ 25 and < 40 kg/m2 - Age ≥ 50 years - Otherwise healthy Exclusion Criteria: - Clinical diagnosis of atherosclerotic vascular disease. - Clinical history of diabetes mellitus or fasting glucose ≥126 mg/dl - Uncontrolled hypertension - Treatment with an investigational new drug within the last 30 days - Clinical history of other major illness including end-stage cancer, renal failure, hepatic failure, or other conditions that in the opinion of the principal investigator make the study inappropriate - Psychological illness or condition such as to interfere with the subject's ability to understand the requirements of the study - Use of Vitamin E, Vitamin C, beta carotene, lipoic acid, or other food or herbal supplements within 1 month of enrollment. Subjects taking multivitamins or other forms of vitamin E and C in doses that do not exceed two times the recommended daily allowance will not be excluded - Extreme dietary habits (i.e. Atkins, very high protein/low carbohydrate, or vegan diet

Additional Information

Official title Effect Of Concord Grape Juice On Endothelial Function In Obese And Overweight Individuals Over Age 50
Principal investigator Joseph A Vita, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by Boston University.