Effect of Concord Grape Juice on Endothelial Function

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Welch's, Inc.
Information provided by (Responsible Party):
Boston University
ClinicalTrials.gov Identifier:
NCT01775748
First received: January 23, 2013
Last updated: July 15, 2014
Last verified: July 2014
  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: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Effect Of Concord Grape Juice On Endothelial Function In Obese And Overweight Individuals Over Age 50

Resource links provided by NLM:


Further study details as provided by Boston University:

Primary Outcome Measures:
  • Brachial artery flow mediated dilation [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Endothelial function will be assessed as brachial artery flow-mediated dilation using vascular ultrasound


Secondary Outcome Measures:
  • Nitroglycerin-mediated dilation [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Central aortic stiffness will be assessed as carotid-femoral pulse wave velocity using applanation tonometry

  • Reactive hyperemia [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Fasting glucose and insulin


Estimated Enrollment: 60
Study Start Date: January 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Boston University
ClinicalTrials.gov Identifier: NCT01775748     History of Changes
Other Study ID Numbers: H-31937
Study First Received: January 23, 2013
Last Updated: July 15, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 22, 2014