NCT01746329已完成不适用
Exploratory Study on the Effect of Nutritional Intervention on Postprandial Skeletal Muscle Microcirculation in Obese Subjects
Unilever R&D2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2012年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Vascular resistance
研究概览
简要总结
In the present study, muscle perfusion will be studied before and after an oral glucose challenge following a fasting period.
详细描述
Based on data from previous studies, this physiological response is blunted in obese subjects, and the investigators expect these responses to be restored when the glucose load is combined with tea or beetroot juice in obese, insulin resistant men.
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
- None
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Aged 30-70 years.
- •Obesity (BMI>30 kg/m2)
- •insulin resistance as fasting glucose levels >6.1 mmol/L.
- •Reported intense sport activities >10 h/w.
- •Reported alcohol consumption >28 units/w
- •Signed Informed consent
- •Currently not smoking and being a non-smoker for at least 3 months prior to the start of the study.
排除标准
- •BMI ≥ 40 kg/m
- •Presence of cardiovascular disease.
- •Presence of sudden cardiac death in a 1st degree relative at an age <50 years.
- •Presence of diabetes mellitus type
- •Regular tea drinker (> 2 cups per day)
结局指标
主要结局
Vascular resistance
时间窗: Average of values obtained at 30, 60, 90, 120, 150 and 180 minutes after test product intake corrected for the value obtained at approximately 20 minutes before test product intake (baseline)
Vascular resistance (arm and leg) as obtained from venous occlusion plethysmography and corrected for blood pressure
次要结局
- echo-Doppler(Approximately 20 minutes before (baseline) and 30, 60, 90, 120, 150 and 180 minutes after test product intake)
- Near-infrared spectroscopy(Approximately 20 minutes before (baseline) and 30, 60, 90, 120, 150 and 180 minutes after test product intake)
- Glucose and insulin(Approximately 20 minutes before (baseline) and 30, 60, 90, 120, 150 and 180 minutes after test product intake)
- Vascular resistance exploratory(Approximately 20 minutes before (baseline) and 30, 60, 90, 120, 150 and 180 minutes after test product intake)
研究者
研究点 (2)
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