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Effect of Concord Grape Juice on Endothelial Function

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01775748
First Posted: January 25, 2013
Last Update Posted: March 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Welch's, Inc.
Information provided by (Responsible Party):
Boston University
  Purpose

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.


Condition Intervention
Obesity Overweight Other: Active Concord Grape Juice 12 oz per day Other: Placebo Grape Juice 12 oz per day

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Effect Of Concord Grape Juice On Endothelial Function In Obese And Overweight Individuals Over Age 50

Further study details as provided by Boston University:

Primary Outcome Measures:
  • Brachial artery flow mediated dilation [ Time Frame: 4 weeks ]
    Endothelial function will be assessed as brachial artery flow-mediated dilation using vascular ultrasound


Secondary Outcome Measures:
  • Nitroglycerin-mediated dilation [ Time Frame: 4 weeks ]
    Non-endothelium-dependent dilation will be assessed by measuring the dilator response to sublingual nitroglycerin using vascular ultrasound

  • Carotid-Femoral Pulse Wave Velocity [ Time Frame: 4 weeks ]
    Central aortic stiffness will be assessed as carotid-femoral pulse wave velocity using applanation tonometry

  • Reactive hyperemia [ Time Frame: 4 weeks ]
    We will use vascular ultrasound to determine maximal hyperemic flow velocity in the brachial artery induced by 4-minute cuff occlusion.


Other Outcome Measures:
  • Fasting glucose and insulin [ Time Frame: 4 weeks ]
    Fasting glucose and insulin


Estimated Enrollment: 60
Actual Study Start Date: January 1, 2013
Estimated Study Completion Date: December 2017
Primary Completion Date: July 30, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01775748


Locations
United States, Massachusetts
Boston University School of Medicine
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston University
Welch's, Inc.
Investigators
Principal Investigator: Joseph A Vita, MD Boston University
Principal Investigator: Robert E Eberhardt, MD Boston University
  More Information

Responsible Party: Boston University
ClinicalTrials.gov Identifier: NCT01775748     History of Changes
Other Study ID Numbers: H-31937
First Submitted: January 23, 2013
First Posted: January 25, 2013
Last Update Posted: March 10, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms