Ketone Plasma Kinetics After Oral Intake Of Different MCT Formulae
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
- KetoIndex - plasma concentration
研究概览
简要总结
This research project is aimed at identifying the MCT formulation matrixes that provide the highest ketoindex values and extended half-life, as well as to provide an initial evaluation of the GI tolerability of the various formula. For comparison, ketones salts and esters (food grade) will be also evaluated.
详细描述
Monocentric, open, randomized, controlled research project. The global research project will include several testing cycles as described in the figure 1. In each cycle, several research products (up to 4) will be tested on up to 20 participants in a partial or full cross-over design. Once cycle 1 is completed, blood parameters will be analysed and ketoindex will be calculated as area under the curve (AUC) of total ketones (BHB + AcA) over 4h / quantity of ingested MCTs in g. Based on ketoindex and ketones Thalf (T1/2: time to reach half of AUC-infinite of total ketones) values, new products will be developed for cycle 2.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 18-50 years
- •Healthy men and women, based on the medical screening visit and medical history
- •BMI in the normal and overweight range 18.5 ≤ BMI ≤
- •Able to understand and to sign a written informed consent prior to study entry
排除标准
- •Any medication possibly impacting the postprandial glucose and insulin response (on anamnesis, to the opinion of the medical expert)
- •Any medication impacting dietary fat absorption and metabolism or impacting postprandial glucose and insulin response, to the opinion of the medical expert
- •Pregnancy (on anamnesis) and/or lactation
- •Known food allergy and food intolerance
- •Individuals undergoing either dietary or exercise mediated weight loss program prescribed by a health care professional
- •Individuals under ketogenic diets, or taking regular ketones products such as MCT, ketone esters or ketone salts (calcium, magnesium, sodium, potassium)
- •Alcohol intake higher than 2 servings per day. A serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of bier
- •Having given blood within the last month, or willing to make a blood donation until one month following the end of the study
- •Participant having a hierarchical link with the research team members
- •Not expected to follow the protocol.
- •Smokers unable to stop for the day of the visit
结局指标
主要结局
KetoIndex - plasma concentration
时间窗: 4 hours
KetoIndex calculated as area under the plasma concentration versus time curve (AUC) of total ketones (BHB + AcA) over 4 hours after MCT-based products consumption / quantity of ingested MCTs in gram.
total ketones (BHB+ACA) - Half-life time
时间窗: 4 hours
Half-Life time (T ½) calculated as time to reach half of Area under the plasma concentration versus time curve (AUC)-infinite of total ketones (BHB+ACA) after MCT-based products consumption.
次要结局
- Ketones blood kinetic - Plasma concentration(4 hours)
- Ketones blood kinetics - time to maximum concentration(4 hours)
- Ketones blood kinetics - Half-life time(4 hours)
- Medium chain fatty acid C8 and C10 - plasma concentration(4 hours)
- Medium chain fatty acid C8 and C10 - concentration(4 hours)
- Medium chain fatty acid C8 and C10 - Time to maximum concentration(4 hours)
- Medium chain fatty acid C8 and C10 - Half-life time(4 hours)
- Glucose and insulin - plasma concentration(4 hours)
- Glucose and insulin - peak plasma concentration(4 hours)
- Glucose and insulin- Half-life time(4 hours)
- Ketones blood kinetics - peak plasma concentration(4 hours)
- Glucose and insulin - time to maximum concentration(4 hours)
- Gastro-intestinal tolerability assessment(24 hours)
- Adverse event incidence(24 hours)