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Effect of Concord Grape Juice on Endothelial Function

NCT01775748 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2018-02-12

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Welch's, Inc.

    collaborator INDUSTRY

  • Boston University

    lead OTHER

Principal Investigators

  • Robert E Eberhardt, MD · Boston University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-01-01
Primary Completion
2014-03-19
Completion
2014-03-19

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01775748 on ClinicalTrials.gov