NCT05587426已完成不适用
Postprandial Glucose, and Insulin Response of Sugars From Fiber: An Acute, Double Blind, Randomized Controlled Clinical Trial
Cambridge Glycoscience2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年6月3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
- 20
- 试验地点
- 2
- 主要终点
- Plasma glucose iAUC (T0 - T120min) after test meals
研究概览
简要总结
This goal of this clinical study is to investigate the postprandial glycemic and insulinemic response in healthy adults after the consumption of:
- Sugars from Fiber in comparison with dextrose
- Sugars from Fiber incorporated into chocolate chips in comparison with regular chocolate chips
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals, 20-65 years of age, inclusive.
- •Body mass index (BMI) between 19 and 35 kg/m², inclusive, at screening.
- •Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial.
- •Willing to maintain current dietary supplement and non-exclusionary medication use throughout the trial.
- •Willing to avoid the consumption of alcohol, unusual food intake, and unusual physical activity 24h prior to each study visit. Failure to follow will result in rescheduled visit.
- •Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected. health information to the study investigator.
排除标准
- •Failure to meet any one of the inclusion criteria.
- •Known history of gastrointestinal disease (e.g., diverticulitis, Crohns disease, coeliac disease etc.), bariatric surgery, AIDS, hepatitis, a history or presence of clinically important endocrine (including Type 1 or Type 2 diabetes mellitus), cardiovascular (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), pulmonary, or biliary diseases, 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.
- •Unwillingness or inability to comply with the experimental procedures and to follow INQUIS safety guidelines.
- •Known intolerance, sensitivity or allergy to test foods.
- •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.
- •Exposure to any non-registered drug product within 30 d prior to screening.
- •Self-reported pregnancy or breastfeeding.
结局指标
主要结局
Plasma glucose iAUC (T0 - T120min) after test meals
时间窗: Through intervention periods of two hours
Compare the postprandial glucose incremental area under the curve after consumption of: SFF compared to glucose or SFF chocolate chips compared to regular chocolate chips
次要结局
- Serum insulin iAUC (T0 - T120min) and each time point after test meals(Through intervention periods of two hours)
- Plasma glucose at each time point after test meals(Through intervention periods of two hours)
研究者
研究点 (2)
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