An interventional study of Active Concord Grape Juice 12 oz per day and Placebo Grape Juice 12 oz per day in Obesity and Overweight, sponsored by Boston University. Completed at 1 site in United States. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-12.
Sponsored by Boston University · Not applicable, Interventional, and Other
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.
3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.
This study's enrollment of 77 is close to the median of 73 across 3,175 interventional studies indexed under Overweight.
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Of its 30 completed or terminated interventional studies of FDA-regulated products, 24 (80%) have results posted.
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Exclusion Criteria:
Active Concord Grape Juice 12 oz per day Placebo Grape Juice 12 oz per day
Other: Active Concord Grape Juice 12 oz per day · Other: Placebo Grape Juice 12 oz per day
Placebo Grape Juice 12 oz per day Active Concord Grape Juice 12 oz per day
Other: Active Concord Grape Juice 12 oz per day · Other: Placebo Grape Juice 12 oz per day
Grape Juice 12 oz per day
Placebo Grape Juice 12 oz per day
Brachial artery flow mediated dilation
Endothelial function will be assessed as brachial artery flow-mediated dilation using vascular ultrasound
Time frame: 4 weeks
Nitroglycerin-mediated dilation
Non-endothelium-dependent dilation will be assessed by measuring the dilator response to sublingual nitroglycerin using vascular ultrasound
Time frame: 4 weeks
Carotid-Femoral Pulse Wave Velocity
Central aortic stiffness will be assessed as carotid-femoral pulse wave velocity using applanation tonometry
Time frame: 4 weeks
Reactive hyperemia
We will use vascular ultrasound to determine maximal hyperemic flow velocity in the brachial artery induced by 4-minute cuff occlusion.
Time frame: 4 weeks
Fasting glucose and insulin
Fasting glucose and insulin
Time frame: 4 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Boston University