NCT02352857已完成不适用
Postprandial Glycaemic and Insulinaemic Responses After Consumption of Minicakes Containing FOS in Adults
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Glycaemic response
研究概览
简要总结
The study aims to evaluate the glycaemic and insulinaemic response of short-chain fructo-oligosaccharides (scFOS) used to replace sugars (e.g. dextrose) in foods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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) between 18.0 and 25.0 kg/m² (included);
- •Ready to keep the same volume of physical activity and the same dietary habits during the study and particularly 24 hours before each visit;
- •Be used to have breakfast;
- •Non-smoker for at least 3 months;
- •For the female participant: not being pregnant or breastfeeding and using efficient birth control;
- •Signed the consent form;
- •Able to follow the instructions of the study;
- •Health insured;
- •Accepted to be included in the National Registry for biomedical research Volunteers (Fichier VRB, Volontaires Recherches Biomédicales).
排除标准
- •Fasting blood glucose over 6.1 mmol/L (1.10 g/L) (or diabetes treated or not);
- •Fasting blood cholesterol over 6.35 mmol/L;
- •Fasting blood triglycerides over 1.70 mmol/L (or history of insulinoma);
- •Fasting blood insulin under 20 mU/L;
- •Fasting HbA1c under 7%;
- •History of hypercholesterolemia, hypertension, diabetes or glucose intolerance treated or not;
- •History of dietary allergies or coeliac disease;
- •History of digestive system disease susceptible to modify digestion or absorption like Crohn's disease;
- •Somatic or psychiatric disorders;
- •Renal insufficiency (kidney failure);
- •SGOT or ALAT over 52.5 U/L;
- •Consuming more than 3 alcoholic beverage a day;
- •Weight varied 3 kg the last 3 months.
结局指标
主要结局
Glycaemic response
时间窗: 2 hours and 5 minutes
Blood glucose kinetics with 7 points. Analysis of the Area under the curve of glucose.
次要结局
- Insulinaemic response(2 hours and 5 minutes)
- Blood glucose peak (Cmax)(One-time data (the highest one) within the 2hrs 5mins kinetics.)
- Blood insulin peak (Cmax)(One-time data (the highest one) within the 2hrs 5mins kinetics.)
- Glucose Tmax : time to reach the peak of blood glucose(One time within the 2hrs 5mins kinetics.)
- Insulin Tmax : time to reach the peak of blood insulin(One time within the 2hrs 5mins kinetics.)
研究者
Jean-Michel Lecerf
MD, Endocrinologist, Nutritionist
Institut Pasteur de Lille
研究点 (2)
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