Clinical trial NCT05398042: Ketone Administration During Inactivity and Retraining
Official title: Effect of Oral Ketone Administration During Inactivity-induced Muscle Atrophy and Retraining-induced Regeneration
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Exercise
Healthy Male/Female Subjects
Keywords: Ketone
Inactivity-induced muscle atrophy
Retraining-induced regeneration
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2022-05-31
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Smoking
* Pregnant
* 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

Primary outcomes:
measure: Exercise performance
timeFrame: Day 0 - day 14 - day 28 - day 42
measure: Echo-Doppler measurement of femoral artery
timeFrame: Day 0 - Day 14 - Day 28 - Day 42
measure: Muscle volume
timeFrame: Day 0 - Day 14 - Day 28 - Day 42
measure: Muscular functional capacity
timeFrame: Day 0 - Day 14 - Day 28 - Day 42
measure: Skeletal muscle biopsies
timeFrame: Day 0 - Day 14 - Day 28 - Day 42
measure: Skeletal muscle biopsies
timeFrame: Day 0 - Day 14 - Day 28 - Day 42
measure: Blood marker of collagen synthesis
timeFrame: Day 0 - Day 14 - Day 28 - Day 42
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Exercise Physiology Research Group
state: Vlaams-Brabant
Study officials:
References: