Bioequivalence of a Diabetes Specific Tube Feed
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Blood glucose - Product A versus Product B
研究概览
简要总结
Nutricia has a range of nutritionally complete tube feeds on the market including some specific for diabetes patients. A new product is currently under development. The aim of the present study is to assess whether the postprandial glucose response of the new product is equivalent to the postprandial glucose response of an original product. In addition, the Glycaemic Index (GI) and Glycaemic Load (GL) of the adapted product will be determined. The study will have a crossover design with healthy volunteers taking one serving of both products in a randomized order. To determine GI and GL of the adapted product subjects will also receive a reference product. Subjects will visit the study site six times: one screening visit, three study visits to measure the glucose response to the reference product and two study visits to measure the glucose response to the test and control product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
Single blind
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 and ≤ 65 years
- •Body Mass Index (BMI) ≥ 18.5 and ≤ 27.0 kg/m2
- •Written informed consent
- •Willingness and ability to comply with the protocol
- •Judged by the Investigator to be in good health
排除标准
- •Known Diabetes Mellitus type I or type II, rebound hypoglycaemia and/or any other medical condition that interferes with glucose metabolism
- •Any use of anticoagulants, systemic steroids, protease inhibitors or antipsychotics and/or any medication known to affect glucose tolerance and/or to influence digestion and absorption of nutrients within 1 week of screening, in opinion of the Investigator
- •Any known disease which influences digestion and absorption of nutrients within 1 week of screening (in the opinion of the Investigator)
- •Allergy to soy and/or any other known relevant food allergy or intolerance in opinion of the Investigator
- •Adherence to a strict vegan diet
- •Adherence to a weight loss program
- •Picky/fussy eater (being very selective about what to eat) or eating disorder
- •Known pregnancy and/or lactation
- •Current smoking or stopped smoking for < 1 month prior to screening (except for incidental smoking of ≤ 3 cigarettes/cigars/pipes per week on average in the last month)
- •Average alcohol use of > 21 glasses per week for men or > 14 glasses per week for women (on average during the last 6 months)
- •Drug or medicine abuse in opinion of the Investigator
- •Any known bleeding disorder
- •Active participation in any other clinical study with investigational or marketed products concomitantly or within 4 weeks before study visit 1, in the opinion of the Investigator
- •Major medical or surgical event requiring hospitalization within the preceding 3 months and/or scheduled in the period of study participation relevant in the opinion of the Investigator
- •Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
- •Employees of Nutricia Research and/or family members or relatives of employees
结局指标
主要结局
Blood glucose - Product A versus Product B
时间窗: 120 minutes
Blood glucose iAUC0-120 \[mmol/L\*min\] \[mmol/L\]
次要结局
- GL new product(120 minutes)
- GI new product(120 minutes)