NCT02074423已完成不适用
A Randomized, Controlled, Double-blind, Cross-over Clinical Trial, Evaluating the Effect of MealShape™ on the Postprandial Glycemia After Eating Standard Food, in Healthy Volunteers.
Dialpha2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2013年3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
- Blood glucose incremental Area Under the Curve between 0 and 120 minutes after consumption of a standard meal, compared between MealShape and the placebo
研究概览
简要总结
The purpose of the study is to evaluate the effect of MealShape, a Ceylon cinnamon extract (Cinnamomum zeylanicum) on blood glucose and insulin response after consumption of a standard meal composed of white bread, in healthy male and female volunteers.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female volunteers, able to read and write, aged from 18 to 45 years inclusive at time of screening
- •Good physical condition
- •Body Mass Index (BMI) ≥ 18,5 and < 25 kg/m²
- •Written informed consent provided prior to screening, after receiving and understanding the subject information
- •Stable body weight (< 5% variation) within the last 3 months prior to screening.
- •Subject accepting to keep the same lifestyle throughout the study regarding physical activity, no smoking etc.
- •Registered with the French Social Security, in agreement with the French law on biomedical experimentation.
排除标准
- •Subject with type 1 or 2 diabetes
- •Smoker. Light smoker (less than 5 cigarettes per day) or former smoker (smoking more than 5 cigarettes per day) having stopped less than three months. Smoking (or use of smoking substitute e.g. nicotine patch) is not permitted from screening throughout the study.
- •Subject with fasting capillary blood glucose level > 110 mg/dl.
- •Subject with fasting capillary blood glucose level ≤ 110 mg/dl and 2 hours postprandial capillary blood glucose level > 140 mg/dl during an Oral Glucose Tolerance Test.
- •Subject with any sensitivity or allergy to any of the products used within this clinical trial.
- •Intake of product (food and dietary supplement) having an effect on glycemia and insulinemia.
- •Intake of all chronic medication excepted oestroprogestative or progestative contraception started at least three months preceding the screening visit.
结局指标
主要结局
Blood glucose incremental Area Under the Curve between 0 and 120 minutes after consumption of a standard meal, compared between MealShape and the placebo
时间窗: Over 120 minutes after the consumption of a standard meal
次要结局
- Blood glucose incremental Area Under the Curve between 0 and 60 minutes compared between MealShape and the placebo after consumption of a standard meal,(Over 60 minutes after consumption of a standard meal)
- Capillary blood glucose maximal concentration between MealShape and Placebo after consumption of a standard meal(Over 120 minutes after consumption of a standard meal)
- Comparison of glycemia values between MealShape and Placebo at the following time points: T0, T15, T30, T45, T60, T90 and T120 minutes after consumption of a standard meal(Over 120 minutes after consumption of a standard meal)
- Evaluation of the safety of MealShape with adverse events recording(3 weeks)
- Insulin incremental Area under the Curve between 0 and 60 minutes compared between MealShape and Placebo after consumption of a standard meal(Over 60 minutes after connsumption of a standard meal)
- Insulin incremental Area under the Curve between 0 and 120 minutes compared between MealShape and Placebo after consumption of a standard meal(Over 120 minutes after consumption of a standard meal)
研究者
研究点 (2)
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