Determination of the Postprandial Glycemic Response and Glycemic Index of Nutritional Products: A Randomized Controlled Clinical Trial in Healthy Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- The glycemic index of nutritional products
研究概览
简要总结
This study assesses the glycemic responses to nutritional products. During a study visit fasted subjects will consume a serving of the reference product or the test product. Capillary blood samples will be taken at baseline and at several time-points over a 2-hr period. Several nutritional products will be tested over time.
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
- None
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) between 18.5 and 27 kg/m²
排除标准
- •Fasting Glucose ≥6.1 at screening visit
- •Known history of gastrointestinal disease, bariatric surgery, AIDS, hepatitis, a history or presence of clinically important endocrine (including Type 1 or Type 2 diabetes mellitus), or any condition which might, in the opinion of the medical director either: 1) make participation dangerous to the subject or to others, or 2)affect the results.
- •Use of medications known to influence carbohydrate metabolism, gastrointestinal function or appetite, including, but not limited to adrenergic blockers, diuretics, thiazolidinediones, metformin and systemic corticosteroids within 4 weeks of the screening visit, or any medication which might, in the opinion of the medical director either: 1) make participation dangerous to the subject or to others, or 2) affect the results.
- •Major trauma or surgical event within 3 months of screening.
- •Known intolerance, sensitivity or allergy to test products.
- •Extreme dietary habits, as judged by the Investigator (i.e. Atkins diet, very high protein diets, etc.).
- •History of cancer in the prior two years, except for non-melanoma skin cancer.
研究组 & 干预措施
Arm 1
All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
干预措施: First Reference Product (Dietary Supplement)
Arm 2
All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
干预措施: Second Reference Product (Dietary Supplement)
Arm 3
All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
干预措施: Third Reference Product (Dietary Supplement)
Arm 4
All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
干预措施: First Concept Product (Dietary Supplement)
Arm 5
All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
干预措施: Second Concept Product (Dietary Supplement)
结局指标
主要结局
The glycemic index of nutritional products
时间窗: From enrollment to the end of treatment at about 6 weeks
次要结局
- 1. The postprandial glucose levels at each time point after each test product compared with the mean of the 3 references(From enrollment to the end of treatment at about 6 weeks)
- 2. The postprandial incremental area under the curve (iAUC) after each test product compared with the mean of the 3 references(From enrollment to the end of treatment at about 6 weeks)