Ketone Administration During Inactivity and Retraining

Exercise Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05398042
• Other study ID #: S65695
• Status: Recruiting
• Phase: Phase 2
• Start date: December 15, 2021
• Est. completion date: August 31, 2022

Study information

• Verified date: May 2022
• Source: KU Leuven
• Contact: Peter Hespel, Prof.
• Phone: +3216329091
• Email: peter.hespel[@]kuleuven.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: August 31, 2022
• Est. primary completion date: June 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Exercise

Intervention

Dietary Supplement:
• Ketone ester
A daily dose of 3x20g of ketone ester supplementation during a six week intervention period
• Medium Chain Triglyceride (MCT) oil
A daily dose of 3x12.8g of MCT oil supplementation during a six week intervention period

Locations

Country	Name	City	State
Belgium	Exercise Physiology Research Group	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise performance	Changes in exercise performance as evaluated during a graded exercise test	Day 0 - day 14 - day 28 - day 42
Primary	Echo-Doppler measurement of femoral artery	Change in blood flow of arteria femoralis	Day 0 - Day 14 - Day 28 - Day 42
Primary	Muscle volume	Change in volume of quadriceps evaluated by computed-tomography scan	Day 0 - Day 14 - Day 28 - Day 42
Primary	Muscular functional capacity	Change in mean power produced during 30 unilateral knee extensions on a knee-extension apparatus	Day 0 - Day 14 - Day 28 - Day 42
Primary	Skeletal muscle biopsies	Changes in myofibrillar protein synthesis	Day 0 - Day 14 - Day 28 - Day 42
Primary	Skeletal muscle biopsies	Changes in connective tissue protein synthesis	Day 0 - Day 14 - Day 28 - Day 42
Primary	Blood marker of collagen synthesis	Change in PINP (n-terminal peptide of pro-collagen I) concentration in blood	Day 0 - Day 14 - Day 28 - Day 42