NCT02168296已完成不适用
Exploratory Study to Assess the Pharmacokinetics in Relation to Blood Glucose and Insulin Levels After Intake of a Plant-based Ingredient in Healthy Subjects
Unilever R&D1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2014年6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
- 20
- 试验地点
- 1
- 主要终点
- AUC of the plant based ingredient calculated by a non-compartmental model
研究概览
简要总结
The study is designed to explore the pharmacokinetics of a Plant-based ingredient in two different matrices, at different dose levels.
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
- 20 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy males, age at start of the study 20 and 50 years
- •Body mass index (BMI) ≥ 20,0 and ≤ 25,0 kg/m2
- •Apparently healthy: no medical conditions which might affect the study measurements, absorption, metabolism and distribution (including diabetes type 1 and type 2, gastrointestinal dysfunction, gastrointestinal surgery and inflammatory diseases)
- •Fasting blood glucose value of subjects is ≥ 3.4 and ≤ 6.1 mmol/litre (i.e. 62-110 mg/dl) at screening
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 intense sporting activities > 10 h/w
- •Consumption of > 21 alcoholic drinks in a typical week
- •Not being used to eat breakfast
- •Reported use of any nicotine containing products in the six months preceding the study and during the study itself
- •Use of medication which interferes with study measurements
- •Reported dietary habits: medically prescribed diet, slimming diet
- •Not used to eat 3 meals a day
- •Vegetarian
- •Reported weight loss/gain (>10%) in the last six month before the study;
- •Allergy or intolerance to food products and aversion to food products;
结局指标
主要结局
AUC of the plant based ingredient calculated by a non-compartmental model
时间窗: predose, 15min, 30min, 45min, 1h, 1.5hrs, 2hrs, 3hrs, 5hrs, 8hrs, 12hrs.
次要结局
- Urinary excretion of Plant-based ingredient(24 hours)
- AUC of the plant based ingredient calculated by a compartmental model(predose, 15min, 30min, 45min, 1hr, 1.5hrs, 2hrs, 3hrs, 5hrs, 8hrs, 12hrs.)
研究者
研究点 (1)
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