Effects of Blood Orange Juice Consumption on Endothelial Function in Healthy Overweight/Obese Men and Premenopausal Women of European Origin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Changes in flow mediated dilation between baseline and endpoint within the intervention group vs. control group
研究概览
简要总结
Epidemiological studies have indicated that the consumption of citrus fruit is inversely associated with the risk of cardiovascular disease. However, clinical data regarding the effects of blood orange juice upon endothelial function is scarce. This randomised, crossover study investigates whether blood orange juice compared to a control drink improves blood vessel function and other cardiovascular health indicators (such as blood pressure and blood lipids). All the subjects will be asked to consume blood orange juice and a control drink in a randomised order, each over a 2-week period, divided by a 1-week wash out period.
详细描述
Endothelial function measured via flow mediated dilation (FMD), blood pressure, anthropometric measures, lipid profile, high-sensitivity C-reactive protein (hsCRP) and endothelin 1 (ET-1), cyclic guanosine monophosphate (cGMP) will be evaluated in healthy overweight/obese Caucasians prior to and following 2-week consumption of blood orange juice and a control drink. Evaluation of endothelial function as measured by FMD will be conducted on specific days of the menstrual cycle to minimise the fluctuation in oestrogen levels in premenopausal women, which will be monitored in serum samples.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Generally healthy
- •Caucasians (of European origin)
- •BMI > 25 kg/m2
排除标准
- •Presence of cardiovascular diseases
- •Use of medications or dietary supplements (vitamins, antioxidants)
- •On a special diet and/or a training program to change weight
研究组 & 干预措施
Blood orange juice
Subjects will be asked to consume blood orange juice (400 ml/day) for 2 weeks.
干预措施: Blood orange juice (Dietary Supplement)
Control drink
Subjects will be asked to consume a control drink (400 ml/day) for 2 weeks.
干预措施: Control drink (Dietary Supplement)
结局指标
主要结局
Changes in flow mediated dilation between baseline and endpoint within the intervention group vs. control group
时间窗: Baseline and 2 weeks; after 1-week wash out, another baseline and 2 weeks.
FMD will be evaluated prior to and following 2-week consumption of either blood orange juice or a control drink.
次要结局
- Changes in blood pressure between baseline and endpoint within the intervention group vs. control group(Baseline and 2 weeks; after 1-week wash out, another baseline and 2 weeks.)
- Changes in flavanone metabolites between baseline and endpoint within the intervention group vs. control group(Baseline and 2 weeks; after 1-week wash out, another baseline and 2 weeks.)
- Changes in high sensitivity C-reactive protein between baseline and endpoint within the intervention group vs. control group(Baseline and 2 weeks; after 1-week wash out, another baseline and 2 weeks.)
- Changes in lipid profile between baseline and endpoint within the intervention group vs. control group(Baseline and 2 weeks; after 1-week wash out, another baseline and 2 weeks.)
- Changes in endothelin-1 (ET-1) between baseline and endpoint within the intervention group vs. control group(Baseline and 2 weeks; after 1-week wash out, another baseline and 2 weeks.)
- Changes in oestradiol between baseline and endpoint within the intervention group vs. control group(Baseline and 2 weeks; after 1-week wash out, another baseline and 2 weeks.)
- Changes in cyclic guanosine monophosphate (cGMP) between baseline and endpoint within the intervention group vs. control group(Baseline and 2 weeks; after 1-week wash out, another baseline and 2 weeks.)