NCT02218528已完成不适用
An Exploratory Study of a Plant-based Ingredient for Reducing the Post-prandial Blood Glucose Response in Healthy Indian Adults, When Administered With a Meal
Unilever R&D1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2014年8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
- 48
- 试验地点
- 1
- 主要终点
- Positive incremental post-prandial blood glucose area unde the curve
研究概览
简要总结
The study is designed to determine the extent to which a plant-based ingredient is able to modulate blood glucose response when administered with a meal.
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
- Single (Participant)
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
- •Healthy males and females, age at start of the study ≥ 18 and ≤ 50 years;
- •Apparently healthy: no medical conditions which might affect the study measurements, as judged by study physician and/or measured by questionnaire, and/or assessed by haematology, blood chemistry and urinalysis;
- •Fasting blood glucose value of subjects 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;
- •Body mass index (BMI) ≥ 18,0 and ≤ 25,0 kg/m2;
- •Agreeing to be informed about medically relevant personal test-results by study physician;
- •Willing to comply to study protocol during study;
- •Willing to refrain from drinking of alcohol on and one day before the blood withdrawal;
- •Accessible veins on arms as determined by examination at screening;
- •Being literate;
- •HbA1C ≤ 6.5 % (48 mmol/mol).
排除标准
- •Any history of diabetes, hyper- (or hypo-) glycemia or other disorder of glucose metabolism;
- •Any history of gastro-intestinal disorders (including frequent diarrhoea for example);
- •Blood donation in the past 2 months;
- •Reported participation in another nutritional or biomedical trial 3 months before the pre-study examination or during the study;
- •Reported participation in night shift work two weeks prior to pre-study investigation or during the study. Night work is defined as working between 23.00 PM and 6.00 AM;
- •Reported intense sporting activities > 10h/w;
- •Consumption of ≥120 ml of alcoholic drinks for males and females in a typical week;
- •Drug abuse as indicated by urine analysis;
- •Chronic smokers, tobacco chewers and drinkers;
- •Use of any medication, including supplements and traditional medicine;
- •Reported dietary habits, such as a medically prescribed/slimming diet;
- •Not being used to eat breakfast;
- •Reported weight loss/gain (>10%) in the last six month before the study;
- •Being an employee of Unilever or CRO;
- •Allergy or intolerance to food products and aversion to food products provided during the study;
- •If female: pregnant or will be planning pregnancy during the study period;
- •If female: lactating or has been lactating in the 6 weeks before pre-study investigation and/or during the study period.
结局指标
主要结局
Positive incremental post-prandial blood glucose area unde the curve
时间窗: 120 minutes
次要结局
- Positive incremental post-prandial blood glucose area under the curve(180 minutes)
- Post-prandial insulin response(180 minutes)
- Assessment of gastric emptying rate(10 hours)
研究者
研究点 (1)
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