NCT05398042

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2021

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2021

Completed
9 days until next milestone

Study Start

First participant enrolled

December 15, 2021

Completed
6 months until next milestone

First Posted

Study publicly available on registry

May 31, 2022

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

May 31, 2022

Status Verified

May 1, 2022

Enrollment Period

6 months

First QC Date

December 6, 2021

Last Update Submit

May 25, 2022

Conditions

ExerciseHealthy Male/Female Subjects

Keywords

KetoneInactivity-induced muscle atrophyRetraining-induced regeneration

Outcome Measures

Primary Outcomes (7)

  • 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Ketone placebo will be provided

Dietary Supplement: Medium Chain Triglyceride (MCT) oil

Ketone

EXPERIMENTAL

Ketone esters will be provided

Dietary Supplement: Ketone ester

Interventions

Ketone esterDIETARY_SUPPLEMENT

A daily dose of 3x20g of ketone ester supplementation during a six week intervention period

Ketone
Medium Chain Triglyceride (MCT) oilDIETARY_SUPPLEMENT

A daily dose of 3x12.8g of MCT oil supplementation during a six week intervention period

Placebo

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exercise Physiology Research Group

Leuven, Vlaams-Brabant, 3001, Belgium

RECRUITING

MeSH Terms

Conditions

Motor ActivityKetosis

Interventions

formic acid 4-(3-oxobutyl)phenyl esterOils

Condition Hierarchy (Ancestors)

BehaviorAcidosisAcid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Lipids

Central Study Contacts

Peter Hespel, Prof.

CONTACT

+3216329091peter.hespel@kuleuven.be

Ruben Robberechts

CONTACT

+3272833757ruben.robberechts@kuleuven.be

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 6, 2021

First Posted

May 31, 2022

Study Start

December 15, 2021

Primary Completion

June 20, 2022

Study Completion

August 31, 2022

Last Updated

May 31, 2022

Record last verified: 2022-05

Locations

BE(1)