NCT02241681已完成不适用
Medium Chain Triglycerides Plasma Profile and Their Metabolites After Oral Peptamen Intake
Société des Produits Nestlé (SPN)2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2014年10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
- 20
- 试验地点
- 2
- 主要终点
- Measure of plasma Medium Chain Triglycerides (MCT)
研究概览
简要总结
Medium Chain Triglycerides (MCT) have been used for many years as a good source of lipid to decrease potential for fat malabsorption. However, the pharmacokinetics of MCT and of their metabolites have not been explored in details.
This is an exploratory study aiming at determining the plasma level of MCT and their metabolites after oral intake of Peptamen.
详细描述
20 subjects will be given 250mL of peptamen 1.5 twice, with 4 hours of interval, on a single day.
Plasma kinetics of MCTs and their metabolites will be made over 8 hours from baseline
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
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
- •Healthy males and females
- •Aged between 20 and 65 years old
- •BMI in the normal range (18.5 to 25.0 kg/m2)
- •Having signed his/her consent form
排除标准
- •Clinically relevant digestive (including malabsorption or major surgery), renal, hepatic, pancreatic or metabolic disease (diabetes, hypo or hyperthyroidism, hypo or hypercorticism), as determined by the medical (screening) visit and a standard blood chemistry analysis (glucose, total cholesterol, ALDL, AHDL, triglycerides, ASAT, ALTI, gamma GT, RCRP, creatinine)
- •Medically diagnosed anemia based on a blood formula
- •Food allergy, lactose intolerance and intolerance to milk proteins (anamnesis)
- •Smokers (anamnesis)
- •Pregnancy (anamnesis)
- •Under corticoids or hormone (adrenal, thyroid) treatment
- •Alcohol intake: > 2 units a day (anamnesis)
- •Consumption of illicit drugs (anamnesis)
- •Having given blood within the last month, or willing to make a blood donation until one month following the end of the study
- •Subject who cannot be expected to comply with the study procedures, including consuming the test product
- •Currently participating or having participated in another clinical trial during the last month prior to the beginning of this study.
结局指标
主要结局
Measure of plasma Medium Chain Triglycerides (MCT)
时间窗: over 8 hours post intake
Tmax, Cmax and AUC for MCTs as compared to baseline.
次要结局
- Measure of plasma MCT metabolites such as free fatty acids(over 8 hours post intake)
研究者
研究点 (2)
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