NCT02323542已完成不适用
Plasma Glucose Kinetics Following Ingestion of Two Cereal Products With a Different Content in Slowly Digestible Starch (SDS) in Healthy Males and Females
Mondelēz International, Inc.2 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2015年4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
- 41
- 试验地点
- 2
- 主要终点
- Rate of appearance of exogenous glucose (RaE)
研究概览
简要总结
The present study aims at investigating the effect of ingesting 2 cereal products differing by their SDS content on the kinetics of glucose in healthy volunteers.
详细描述
The present study will compare the effect of consuming cereal products alone on :
- the rates of appearance and disappearance of exogenous and total glucose
- the glycemic and insulinemic responses
- the postprandial GIP concentrations
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
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteer, male or female (half male, half female);
- •Aged between 18 and 40 years old (bounds included);
- •Non-smoker;
- •BMI ranging between 18.5 and 25 kg/m2 (bounds included)
- •Waist circumference ≤ 94 cm for men and ≤ 80 cm for women;
- •Stable body weight (± 1 kg) over the 3 months preceding the experimental period;
- •Systolic blood pressure between 95 and 145 mmHg and diastolic blood pressure between 50 and 85 mmHg;
- •For the female subjects: use of an oral contraceptive with regular menstrual cycles;
- •Subject not displaying any identified significant metabolic impairment according to the Principal Investigator;
- •Sedentary or with a moderate physical activity;
- •Not having given blood in the month prior to the selection and accepting not to give blood during the experimental period of the present study;
- •Regularly consuming a breakfast providing more than 15% of the total daily energy intake, including at least one cereal product; adequate partitioning of macronutrient intake;
- •Providing written consent for his/her participation to the study;
排除标准
- •Subject with a severe or acute disease which should influence the results of the study and to be life-threatening for the volunteer according to the Principal Investigator;
- •Subject with medical history of symptomatic vascular diseases (infarct, angina pectoris, syndrome of threat, surgery or endovascular surgery, stroke, symptomatic peripheral arteritis) which according to the investigator should interfere with the results from the study or should constitute a particular risk for the subject;
- •Subject with type 1 or type 2 diabetes;
- •Subject with any food allergy;
- •Subject with eating disorders (e.g. anorexia nervosa & bulimia) according to the Principal Investigator;
- •Subject regularly consuming more than 20 g/day of alcohol;
- •Subject regularly consuming recreational drugs;
- •Subject consuming regularly corticoids, anorectics, adrenergic drugs, gastric demulcent, cholesterol and/or lipid lowering medication, weight-loss drugs or other drugs or supplement that should impact glucose metabolism in the Principal Investigator's opinion;
- •Pregnant or lactating women;
- •Currently participating in another study or having participated in another study in the 3 months prior to the selection visit;
- •Consuming large amounts of food products naturally rich in 13C.
结局指标
主要结局
Rate of appearance of exogenous glucose (RaE)
时间窗: T0 to 300 minutes
Postprandial kinetic of RaE
次要结局
- iAUC RaE(T0 to 300 minutes)
- kinetics of Rate of disappearance of exogenous glucose (RdE), Rate of appearance of total glucose (RaT), Rate of disappearance of total glucose (RdT) and Endogenous glucose production (EGP)(T0 to 300 minutes)
- iAUC of RdE, RaT, RdT and EGP(T0 to 300 minutes)
- iAUC of glycemia and insulinemia(T0 to 300 minutes)
- kinetics of glycemia and insulinemia(T-120 to 300 minutes)
- Kinetics of plasma glucose-dependent insulinotropic peptide (GIP) concentration(T0 to 300 minutes)
- iAUC of GIP(T0 to 300 minutes)
- Kinetics of plasma FFA concentration(T0 to 300 minutes)
- dAUC of FFA(T0 to 300 minutes)
研究者
研究点 (2)
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