NCT01146470已完成不适用
A Single-Center, Double-blind, Random, Parallel Controlled Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To investigate the influence of RGC on blood pressure and vascular function.
研究概览
简要总结
The study hypothesis is that 3 Months Daily Supplementation of RGC will effect blood pressure and vascular function.
This will be a single-center, double-blind, random, parallel controlled Study. Study population will include 60 subjects, who will be divided randomly into three groups. The first group will get RGC 200mg, the second group will get RGC 400mg, and the third group will get 200mg placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 35-70
- •BMI < 40.0 kg/m2
- •Blood pressure: SYS. ≤154 mmHg, DIA. ≤93 mmHg.
排除标准
- •Breastfeeding or pregnancy.
- •Milk allergy - the substance may contain traces of milk protein (casein).
- •Taking anti-hypertensive medications.
- •Taking antioxidant food supplements, excluding probiotic agents and fibers (taken for less than two weeks before beginning the study).
- •Subjects suffering from any of the following conditions: cardiovascular disorders, renal disorders, intestinal disorders, hepatic disease, malignant or autoimmune diseases or other metabolic diseases.
- •A subject whose baseline blood tests indicate abnormalities in hepatic or renal function, thyroid function or blood count.
- •Unusual eating habits.
- •The subject is in the process of active weight loss / gain.
- •Addiction to drugs / alcohol.
- •Medically documented psychiatric problems or neurological disorders.
- •Smokers. (Subjects who quit smoking more than two years ago may be included in the study).
- •Systolic blood pressure above 154 mmHg.
- •Diastolic blood pressure above 93 mmHg.
- •Taking phosphodiesterase 5 inhibitors for the treatment of erectile dysfunction (Viagra, Cialis, etc.).
结局指标
主要结局
To investigate the influence of RGC on blood pressure and vascular function.
时间窗: 3 months of treatment
次要结局
- The change in oxidative stress parameters(3 months of treatment)
研究者
研究点 (1)
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