Ketone Administration During Inactivity and Retraining

Phase 2

• Conditions: Healthy Male/Female Subjects; Exercise
• Interventions: Dietary Supplement: Ketone ester; Dietary Supplement: Medium Chain Triglyceride (MCT) oil

• Registration Number: NCT05398042
• Lead Sponsor: KU Leuven

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-06
• Study Start: 2021-12-15
• Status Verified: 2022-05
• Study First Submitted QC: 2022-05-25
• Last Update Submitted: 2022-05-25
• Study First Posted: 2022-05-31
• Last Update Posted: 2022-05-31
• Primary Completion: 2022-06-20
• Study Completion: 2022-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketone	Ketone ester	Ketone esters will be provided
Placebo	Medium Chain Triglyceride (MCT) oil	Ketone placebo will be provided

Primary Outcome Measures

Name	Time	Method
Muscle volume	Day 0 - Day 14 - Day 28 - Day 42	Change in volume of quadriceps evaluated by computed-tomography scan
Muscular functional capacity	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	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	Day 0 - Day 14 - Day 28 - Day 42	Change in blood flow of arteria femoralis
Skeletal muscle biopsies	Day 0 - Day 14 - Day 28 - Day 42	Changes in connective tissue protein synthesis
Blood marker of collagen synthesis	Day 0 - Day 14 - Day 28 - Day 42	Change in PINP (n-terminal peptide of pro-collagen I) concentration in blood

Trial Locations

Locations (1)

Exercise Physiology Research Group; 🇧🇪 Leuven, Vlaams-Brabant, Belgium