The Effects of a 4-week Supplementation With a Ketogenic Nutrient Mix on 24-hour Substrate Metabolism and Muscle Health
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Delta respiratory exchange ratio (from 23:00 till 04:00)
研究概览
简要总结
This study will investigate the effect of providing a daily ketogenic nutritional supplement in the evening for a prolonged time (4 weeks) to induce a mild ketogenic state during the night in healthy elderly (60-80 years), overweight/obese (BMI: 25-35 kg/m2) individuals with low physical activity, on 24h rhythmicity in energy metabolism as compared to a non-ketogenic, isocaloric control.
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
- •Sedentary lifestyle (not more than 2 hours of structured physical activity per week in the past 3 months)
- •Stable dietary habits (no weight loss or gain > 5 kg in the past 3 months)
- •Healthy (as determined by dependent physician based on medical questionnaire)
- •Regular sleeping habits (7-9h of daily sleep)
排除标准
- •Type 2 diabetes
- •Participants with active congestive heart failure and/or severe renal and or liver insufficiency
- •Uncontrolled hypertension
- •Alcohol consumption of >3 servings per day for men and >2 servings per day for women
- •Unstable body weight (weight gain or loss > 5 kg in the last 3 months) or intention to lose weight
- •Participants who are on an intermittent fasting diet
- •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 or study product)
- •Participants who do not want to be informed about unexpected medical findings
- •Blood donation during or within 2 months prior to the study
- •Disturbances in circadian rhythm determined with the follow criteria:
- •Extreme early bird or extreme night person (score ≤30 or ≥70 on MEQ-SA questionnaire)
- •Heavily varying sleep-wake rhythm
- •Night shift work during last 3 months
- •Travel across > 1 time zone in the last 3 months
- •High daily caffeine intake > 400mg (more than 4 cups of coffee or energy drinks)
研究组 & 干预措施
Ketogenic nutritional supplement
Daily ketogenic nutritional supplement for 4 weeks
干预措施: ketogenic nutritional Supplement (Dietary Supplement)
non-ketogenic, isocaloric control
Daily control for 4 weeks
干预措施: non-ketogenic, isocaloric control (Dietary Supplement)
结局指标
主要结局
Delta respiratory exchange ratio (from 23:00 till 04:00)
时间窗: Measured after 4 weeks of daily supplementation with a ketogenic nutritional supplement or non-ketogenic, isocaloric control
Measured with indirect calorimetry
次要结局
- Skeletal mitochondrial function(Measured after 4 weeks of daily supplementation with a ketogenic nutritional supplement or non-ketogenic, isocaloric control)