Effect of Concord Grape Juice on Endothelial Function

Obesity Clinical Trial

Official title:

Effect Of Concord Grape Juice On Endothelial Function In Obese And Overweight Individuals Over Age 50

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01775748
• Other study ID #: H-31937
• Status: Completed
• Phase: N/A
• First received: January 23, 2013
• Last updated: February 9, 2018
• Start date: January 1, 2013
• Est. completion date: March 19, 2014

Study information

• Verified date: February 2018
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: March 19, 2014
• Est. primary completion date: March 19, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Other:
• 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

Locations

Country	Name	City	State
United States	Boston University School of Medicine	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston University	Welch's, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fasting glucose and insulin	Fasting glucose and insulin	4 weeks
Primary	Brachial artery flow mediated dilation	Endothelial function will be assessed as brachial artery flow-mediated dilation using vascular ultrasound	4 weeks
Secondary	Nitroglycerin-mediated dilation	Non-endothelium-dependent dilation will be assessed by measuring the dilator response to sublingual nitroglycerin using vascular ultrasound	4 weeks
Secondary	Carotid-Femoral Pulse Wave Velocity	Central aortic stiffness will be assessed as carotid-femoral pulse wave velocity using applanation tonometry	4 weeks
Secondary	Reactive hyperemia	We will use vascular ultrasound to determine maximal hyperemic flow velocity in the brachial artery induced by 4-minute cuff occlusion.	4 weeks