Effect of Concord Grape Juice on Endothelial Function

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight
• Intervention / Treatment: Other: Active Concord Grape Juice 12 oz per day; Other: Placebo Grape Juice 12 oz per day

• Study Type: Interventional
• Enrollment (Actual): 77
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston University School Of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Active First; Active Concord Grape Juice 12 oz per day Placebo Grape Juice 12 oz per day	Other: Active Concord Grape Juice 12 oz per day; Grape Juice 12 oz per day; Other: Placebo Grape Juice 12 oz per day; Placebo Grape Juice 12 oz per day
Other: Placebo First; Placebo Grape Juice 12 oz per day Active Concord Grape Juice 12 oz per day	Other: Active Concord Grape Juice 12 oz per day; Grape Juice 12 oz per day; Other: Placebo Grape Juice 12 oz per day; Placebo Grape Juice 12 oz per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brachial artery flow mediated dilation	Endothelial function will be assessed as brachial artery flow-mediated dilation using vascular ultrasound	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nitroglycerin-mediated dilation	Non-endothelium-dependent dilation will be assessed by measuring the dilator response to sublingual nitroglycerin using vascular ultrasound	4 weeks
Carotid-Femoral Pulse Wave Velocity	Central aortic stiffness will be assessed as carotid-femoral pulse wave velocity using applanation tonometry	4 weeks
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting glucose and insulin	Fasting glucose and insulin	4 weeks

Collaborators and Investigators

• Sponsor: Boston University
• Collaborators: Welch's, Inc.
• Investigators: Principal Investigator: Robert E Eberhardt, MD, Boston University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): March 19, 2014
• Study Completion (Actual): March 19, 2014

Study Registration Dates

• First Submitted: January 23, 2013
• First Submitted That Met QC Criteria: January 24, 2013
• First Posted (Estimate): January 25, 2013

Study Record Updates

• Last Update Posted (Actual): February 12, 2018
• Last Update Submitted That Met QC Criteria: February 9, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Grape juice
• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: H-31937

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No