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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05398042
Other study ID # S65695
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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