Effect Of Concord Grape Juice On Endothelial Function In Obese And Overweight Individuals Over Age 50
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 2
- 主要终点
- Brachial artery flow mediated dilation
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index ≥ 25 and < 40 kg/m2
- •Age ≥ 50 years
- •Otherwise healthy
排除标准
- •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
研究组 & 干预措施
Active First
Active Concord Grape Juice 12 oz per day Placebo Grape Juice 12 oz per day
干预措施: Active Concord Grape Juice 12 oz per day (Other)
Active First
Active Concord Grape Juice 12 oz per day Placebo Grape Juice 12 oz per day
干预措施: Placebo Grape Juice 12 oz per day (Other)
Placebo First
Placebo Grape Juice 12 oz per day Active Concord Grape Juice 12 oz per day
干预措施: Active Concord Grape Juice 12 oz per day (Other)
Placebo First
Placebo Grape Juice 12 oz per day Active Concord Grape Juice 12 oz per day
干预措施: Placebo Grape Juice 12 oz per day (Other)
结局指标
主要结局
Brachial artery flow mediated dilation
时间窗: 4 weeks
Endothelial function will be assessed as brachial artery flow-mediated dilation using vascular ultrasound
次要结局
- Nitroglycerin-mediated dilation(4 weeks)
- Reactive hyperemia(4 weeks)
- Carotid-Femoral Pulse Wave Velocity(4 weeks)