Determination of the Optimal Nutrient Mix to Acutely Increase Plasma Ketones
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Plasma ketone levels
研究概览
简要总结
This study will be performed to determine the optimal nutrient mix (predominantly based on medium-chain triglycerides (MCTs)) to induce a mild ketogenic state in healthy older (60-80y), overweight/obese (BMI: 25-35 kg/m2) individuals. Since the aim is to induce a mild ketogenic state, a 25g MCT-based nutrient mix, a 25g MCT-based nutrient mix + cofactors, or a non-ketogenic control will be compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 60-80 years
- •Body mass index (BMI) 25-35 kg/m2
- •Stable dietary habits (no weight loss or gain > 5 kg in the past 3 months)
- •Participants are able to provide signed and dated written informed consent prior to any study specific procedures
排除标准
- •Type 2 diabetes
- •Pre-diabetes based on one or a combination of the following criteria:
- •ImpairedFastingGlucose(IFG):Fasting plasma glucose ≥ 6.1mmol/l and ≤ 6.9 mmol/l.
- •HbA1c of 5.7-6.4%.
- •Participants with active congestive heart failure and/or severe renal and or liver insufficiency
- •Uncontrolled hypertension
- •Alcohol consumption of > 3 servings per day for man and > 2 servings per day for woman
- •Unstable body weight (weight gain or loss > 5 kg in the last 3 months)
- •Previous enrolment in a clinical study with an investigational product during the last 3 months or as judged by the investigator which would possibly hamper our study results
- •Significant food allergies/intolerance (seriously hampering study meals)
- •Participants who do not want to be informed about unexpected medical findings
- •Blood donation during or within 2 months prior to the study
研究组 & 干预措施
non-ketogenic control
干预措施: non-ketogenic control (Dietary Supplement)
25g MCT-based nutrient mix + cofactors
干预措施: 25g MCT-based nutrient mix + cofactors (Dietary Supplement)
25g MCT-based nutrient mix
干预措施: 25g MCT-based nutrient mix (Dietary Supplement)
结局指标
主要结局
Plasma ketone levels
时间窗: Testday 1, 2, and 3
The primary outcome is plasma ketone levels determined regularly over a defined time period after ingestion of the respective nutritional supplements, expressed as area under the curve (AUC).
次要结局
未报告次要终点