Effect of Oral Ketone Administration During Inactivity-induced Muscle Atrophy and Retraining-induced Regeneration

KU Leuven1 site in 1 country24 target enrollmentStarted: December 15, 2021Last updated: May 31, 2022

Conditions

Interventions

Trial Snapshot

Phase: Phase 2
Sponsor: KU Leuven
Enrollment: 24
Locations: 1
Primary Endpoint: Skeletal muscle biopsies

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

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.

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages: 18 Years to 35 Years (Adult)
Sex: All
Accepts Healthy Volunteers: Yes

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
•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

Arms & Interventions

Placebo

Placebo Comparator

Ketone placebo will be provided

Intervention: Medium Chain Triglyceride (MCT) oil (Dietary Supplement)

Ketone

Experimental

Ketone esters will be provided

Intervention: Ketone ester (Dietary Supplement)