Effect of Concord Grape Juice on Endothelial Function
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 50 - Any |
| Updated: | 2/14/2018 |
| Start Date: | January 1, 2013 |
| End Date: | March 19, 2014 |
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.
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.
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
We found this trial at
1
site
72 East Concord Street
Boston, Massachusetts 02118
Boston, Massachusetts 02118
(617) 638-5300
Boston University School of Medicine A leader in medical education and research, Boston University School...
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