NCT05058157进行中（未招募）不适用
Ketone Plasma Kinetics After Oral Intake of Different Ketogenic Formulae
Société des Produits Nestlé (SPN)1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年8月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Ketone Plasma Kinetics After Oral Intake of Different Ketogenic Formulae
研究概览
简要总结
This research project aims at evaluating the effect of various ketone precursors and their formulations on blood ketone level after oral intake. Evaluation of the GI tolerability of the various formula will be also evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- •Healthy men and women, based on the screening visit and medical history,
- •BMI in the normal and overweight range 18.5 ≤ BMI ≤ 27;
- •Able to understand and sign informed consent form.
排除标准
- •Any medication possibly impacting the postprandial glucose and insulin response (based on anamnesis),
- •Any medication impacting dietary fat absorption and metabolism,
- •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,
- •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,
- •Family or hierarchical relationships with Clinical Innovation Lab at Nestlé Research, Lausanne, Switzerland,
- •Volunteer who cannot be expected to comply with the protocol,
- •Smokers unable to stop for the day of the visit.
结局指标
主要结局
Ketone Plasma Kinetics After Oral Intake of Different Ketogenic Formulae
时间窗: 0 (baseline) to 4 hours after products consumption
Incremental area under the curve of total blood ketones
次要结局
未报告次要终点
研究者
研究点 (1)
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