NCT01955447已完成不适用
Effect of Different Levels of Plant-based Ingredients on Post-prandial Glucose in Healthy Subjects
Unilever R&D1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2013年11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
- 84
- 试验地点
- 1
- 主要终点
- Post-prandial blood glucose area under the curve
研究概览
简要总结
The study is designed to determine the extent to which foods containing different levels of plant-based ingredients affect blood glucose responses in healthy subjects.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willing to give consent to participate in the study in writing;
- •Healthy male and female subjects, between the age of ≥20 and ≤50 yrs of age at first screening visit;
- •Body Mass Index (BMI) between ≥18 and ≤ 25 kg/m2;
- •Apparently healthy: no medical conditions which might affect study measurement, as judged by study physician and/or measured by questionnaire, and/or assessed by haematology, blood chemistry and urinalysis;
- •Willing to comply to study protocol during the study;
- •Agreeing to be informed about medically relevant personal test-results by study physician;
- •Willing to refrain from drinking of alcohol on and one day before the blood withdrawal;
- •Fasting blood glucose value of volunteer is ≥ 3.4 and ≤ 6.1 mmol/litre (i.e. 62-110 mg/dl) at screening;
- •Haemoglobin level within clinically acceptable range (for male 12 to 17 gm/dL and for females 11 to 15 gm / dL; both inclusive) as judged by the research physician.
排除标准
- •Being an employee of Unilever or CRO;
- •Chronic smokers, tobacco chewers and drinkers;
- •Participation in any other biomedical study 3 months before screening visit day of this study and/or participating in any other biomedical study during the screening period;
- •Use of medication which interferes with study measurements including vitamins, tonics;
- •Reported intense exercise ≥10 h/week;
- •Reported weight loss/gain ≥ 10% of body weight in the 6 months preceding screening
- •Blood donation for 2 months prior to screening;
- •Urine analysis that showed any drug abuse;
- •Allergy to any food or cosmetics;
- •If female, not being pregnant or planning pregnancy during the study period;
- •If female, lactating or has been lactating for 6 weeks before pre-study investigation and/or during the study period.
结局指标
主要结局
Post-prandial blood glucose area under the curve
时间窗: 120 minutes
次要结局
- Post-prandial insulin area under the curve(120 minutes)
研究者
研究点 (1)
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