NCT02353403已完成不适用
Postprandial Glycaemic and Insulinaemic Responses After Consumption of Dairy Desserts Containing Fructo-oligosaccharides in Adults.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 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
- 主要目的
- Basic Science
- 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
研究组 & 干预措施
Sugar
Placebo Comparator
Control group consuming a dairy dessert containing 35g of dextrose.
干预措施: Sugar (Other)
FOS
Experimental
Group consuming a dairy dessert in which 30% of the dextrose was replaced by FOS.
干预措施: FOS (Other)
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)
- Insulin Tmax : time to reach the peak of blood insulin(One time 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.)
- Blood glucose peak (Cmax)(One-time data (the highest one) 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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