NCT02388503已完成不适用
The Effect of a Natural Extract on the Post-prandial Blood Glucose Response After Bread Consumption: a Dose-response of Efficacy
Unilever R&D2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2015年2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
- 64
- 试验地点
- 2
- 主要终点
- Positive incremental post-prandial blood glucose area under the curve
研究概览
简要总结
This study is designed to identify the minimal effective tested dose of fruit extract consumed with a bread which provides a reduction in venous post-prandial blood glucose compared to a reference bread.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m
- •Apparently healthy males and females: no medical conditions which might affect the study measurements including diabetes type 1 and type 2, gastrointestinal dysfunction, gastrointestinal surgery and inflammatory diseases.
- •Fasting blood glucose value of subjects ≥ 3.4 and ≤ 6.1 mmol/litre (i.e. 62-110 mg/dl) at screening.
排除标准
- •Use of antibiotics within 3 months before day 1; use of any other medication except paracetamol, within 14 days before day
- •Blood donation in the past 3 months and/or during the study.
- •Reported intense sporting activities > 10 h/week.
- •Consumption of > 14 units (female subjects) and > 21 units (male subjects) alcoholic drinks in a typical week.
- •Reported dietary habits: medically prescribed diet, slimming diet, not used to eat 3 meals a day, vegetarian.
- •If female, is pregnant (or has been pregnant during the last < 3 months) or will be planning pregnancy during the study period.
- •If female, is lactating or has been lactating in the 6 weeks before screening and/or during the study period.
- •Dislike, known allergy or intolerance to test products or other food products provided during the study.
结局指标
主要结局
Positive incremental post-prandial blood glucose area under the curve
时间窗: 120 minutes
次要结局
- Post-prandial insulin response(180 minutes)
- AUC of fruit extract calculated by a non-compartmental model(180 minutes)
- Positive incremental post-prandial blood glucose area under the curve(180 minutes)
- AUC of fruit extract calculated by a population model(180 minutes)
研究者
研究点 (2)
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