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Ketone Administration During Inactivity and Retraining

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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05398042
Enrollment
24
Registered
2022-05-31
Start date
2021-12-15
Completion date
2022-08-31
Last updated
2022-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exercise, Healthy Male/Female Subjects

Keywords

Ketone, Inactivity-induced muscle atrophy, Retraining-induced regeneration

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.

Interventions

DIETARY_SUPPLEMENTMedium Chain Triglyceride (MCT) oil

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

DIETARY_SUPPLEMENTKetone ester

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

Sponsors

KU Leuven
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Exercise performanceDay 0 - day 14 - day 28 - day 42Changes in exercise performance as evaluated during a graded exercise test
Echo-Doppler measurement of femoral arteryDay 0 - Day 14 - Day 28 - Day 42Change in blood flow of arteria femoralis
Muscle volumeDay 0 - Day 14 - Day 28 - Day 42Change in volume of quadriceps evaluated by computed-tomography scan
Muscular functional capacityDay 0 - Day 14 - Day 28 - Day 42Change in mean power produced during 30 unilateral knee extensions on a knee-extension apparatus
Skeletal muscle biopsiesDay 0 - Day 14 - Day 28 - Day 42Changes in myofibrillar protein synthesis
Blood marker of collagen synthesisDay 0 - Day 14 - Day 28 - Day 42Change in PINP (n-terminal peptide of pro-collagen I) concentration in blood

Countries

Belgium

Contacts

Primary ContactPeter Hespel, Prof.
peter.hespel@kuleuven.be+3216329091
Backup ContactRuben Robberechts
ruben.robberechts@kuleuven.be+3272833757

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026