Effect of Oral Ketone Administration During Inactivity-induced Muscle Atrophy and Retraining-induced Regeneration
试验速览
- 阶段
- 2 期
- 发起方
- KU Leuven
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Muscle volume
研究概览
简要总结
The aim of this study is to investigate the effect of oral ketone administration during inactivity-induced muscle atrophy and retraining-induced regeneration. Potential changes in muscle function (cycling performance, knee-extension force and power, jump height) and mass, blood flow and the muscular extracellular matrix will be the main focus. In this context, the dominant leg of the participants (n=24) will be immobilized with a brace for 2 weeks and subsequently retrained in a 4-week progressive resistance exercise training program to stimulate muscle regeneration. During the immobilization and rehabilitation period, participants receive either ketone ester (KE) or placebo (CON). 4 experimental sessions are performed during this time frame in order to evaluate the effects of the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Recreational sports participation, including general fitness training, between 2 and 5 hours max per week
- •Good health status confirmed by a medical screening
- •Body mass index between 18 and 25
排除标准
- •Any kind of injury/pathology that is a contra-indication to perform resistance exercise
- •Intake of any medication or nutritional supplement that could impact muscle protein synthesis during the period of the study
- •Intake of any whey protein, casein or branched-chain amino acid supplement or anti-inflammatory drug from 1 month prior to the start of the study
- •Blood donation within 3 months prior to the start of the study
- •More than 3 alcoholic beverages per day
- •Current participation in another research trial
- •Any other argument to believe that the subject is unlikely to successfully complete the full study protocol
- •Adherence to a high-fat, low-carbohydrate ketogenic diet (less than 20% of energy intake derived from carbohydrates)
- •(Cow's) milk protein allergy
结局指标
主要结局
Muscle volume
时间窗: Day 0 - Day 14 - Day 28 - Day 42
Change in volume of quadriceps evaluated by computed-tomography scan
Muscular functional capacity
时间窗: Day 0 - Day 14 - Day 28 - Day 42
Change in mean power produced during 30 unilateral knee extensions on a knee-extension apparatus
Exercise performance
时间窗: Day 0 - day 14 - day 28 - day 42
Changes in exercise performance as evaluated during a graded exercise test
Echo-Doppler measurement of femoral artery
时间窗: Day 0 - Day 14 - Day 28 - Day 42
Change in blood flow of arteria femoralis
Blood marker of collagen synthesis
时间窗: Day 0 - Day 14 - Day 28 - Day 42
Change in PINP (n-terminal peptide of pro-collagen I) concentration in blood
Skeletal muscle biopsies
时间窗: Day 0 - Day 14 - Day 28 - Day 42
Changes in myofibrillar protein synthesis
次要结局
未报告次要终点