Ketone Administration During Inactivity and Retraining

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

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 Overview

• Status: Recruiting
• Conditions: Exercise; Healthy Male/Female Subjects
• Intervention / Treatment: Dietary supplement: Medium Chain Triglyceride (MCT) oil; Dietary supplement: Ketone ester

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Peter Hespel, Prof.; Phone Number: +3216329091; Email: peter.hespel@kuleuven.be
• Study Contact Backup: Name: Ruben Robberechts; Phone Number: +3272833757; Email: ruben.robberechts@kuleuven.be

Study Locations

• Belgium
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3001
      • Recruiting
      • Exercise Physiology Research Group
      • Contact: Peter Hespel, Prof.; Phone Number: +3216329091; Email: peter.hespel@kuleuven.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Ketone placebo will be provided	Dietary supplement: Medium Chain Triglyceride (MCT) oil; A daily dose of 3x12.8g of MCT oil supplementation during a six week intervention period
Experimental: Ketone; Ketone esters will be provided	Dietary supplement: Ketone ester; A daily dose of 3x20g of ketone ester supplementation during a six week intervention period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exercise performance	Changes in exercise performance as evaluated during a graded exercise test	Day 0 - day 14 - day 28 - day 42
Echo-Doppler measurement of femoral artery	Change in blood flow of arteria femoralis	Day 0 - Day 14 - Day 28 - Day 42
Muscle volume	Change in volume of quadriceps evaluated by computed-tomography scan	Day 0 - Day 14 - Day 28 - Day 42
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
Skeletal muscle biopsies	Changes in myofibrillar protein synthesis	Day 0 - Day 14 - Day 28 - Day 42
Skeletal muscle biopsies	Changes in connective tissue protein synthesis	Day 0 - Day 14 - Day 28 - Day 42
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

Collaborators and Investigators

• Sponsor: KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2021
• Primary Completion (Anticipated): June 20, 2022
• Study Completion (Anticipated): August 31, 2022

Study Registration Dates

• First Submitted: December 6, 2021
• First Submitted That Met QC Criteria: May 25, 2022
• First Posted (Actual): May 31, 2022

Study Record Updates

• Last Update Posted (Actual): May 31, 2022
• Last Update Submitted That Met QC Criteria: May 25, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Ketone; Inactivity-induced muscle atrophy; Retraining-induced regeneration
• Other Study ID Numbers: S65695

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes