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Completed

NCT Number: NCT01775748

Effect of Concord Grape Juice on Endothelial Function

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston University School of Medicine

Boston, Massachusetts, 02118, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active Concord Grape Juice 12 oz per day

Other

Grape Juice 12 oz per day

Placebo Grape Juice 12 oz per day

Other

Placebo Grape Juice 12 oz per day

Primary outcomes

  1. Brachial artery flow mediated dilation

    Time frame: 4 weeks

    Endothelial function will be assessed as brachial artery flow-mediated dilation using vascular ultrasound

Secondary outcomes

  1. 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

  2. Carotid-Femoral Pulse Wave Velocity

    Time frame: 4 weeks

    Central aortic stiffness will be assessed as carotid-femoral pulse wave velocity using applanation tonometry

  3. 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 outcomes

  1. Fasting glucose and insulin

    Time frame: 4 weeks

    Fasting glucose and insulin

Sponsors and collaborators

Lead sponsor

Boston University

Other

Collaborators

  • Welch's, Inc.

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 25, 2013
Registry last updated
Feb 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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