ExercisePhase 2NCT05398042
Ketone Administration During Inactivity and Retraining
A Phase 2 study testing Ketone ester and Medium Chain Triglyceride (MCT) oil in people with Exercise and Healthy Male/Female Subjects, run by KU Leuven at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise, Healthy Male/Female Subjects
- What is being tested?
- Ketone ester and Medium Chain Triglyceride (MCT) oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Dec 2021to 31 Aug 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Exercise Physiology Research Group
Leuven, Vlaams-Brabant, 3001
Peter Hespel, Prof., +3216329091, peter.hespel@kuleuven.be
About this study
Official title: 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.
- Conditions
- Exercise, Healthy Male/Female Subjects
- Being tested
- Ketone ester, Medium Chain Triglyceride (MCT) oil
- Keywords
- Ketone, Inactivity-induced muscle atrophy, Retraining-induced regeneration
- Medical subject headings
- Motor Activity, Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketone esterDietary supplement
A daily dose of 3x20g of ketone ester supplementation during a six week intervention period
Medium Chain Triglyceride (MCT) oilDietary supplement
A daily dose of 3x12.8g of MCT oil supplementation during a six week intervention period
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Ketone placebo will be provided Receives: Dietary Supplement: Medium Chain Triglyceride (MCT) oil |
| Ketone | Experimental | Ketone esters will be provided Receives: Dietary Supplement: Ketone ester |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise performance
Changes in exercise performance as evaluated during a graded exercise test
Measured: Day 0 - day 14 - day 28 - day 42
Echo-Doppler measurement of femoral artery
Change in blood flow of arteria femoralis
Measured: Day 0 - Day 14 - Day 28 - Day 42
Muscle volume
Change in volume of quadriceps evaluated by computed-tomography scan
Measured: 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
Measured: Day 0 - Day 14 - Day 28 - Day 42
Skeletal muscle biopsies
Changes in myofibrillar protein synthesis
Measured: Day 0 - Day 14 - Day 28 - Day 42
Skeletal muscle biopsies
Changes in connective tissue protein synthesis
Measured: 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
Measured: Day 0 - Day 14 - Day 28 - Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start15 Dec 2021
- Primary completion20 Jun 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Hespel, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05398042
- Sponsor's protocol ID
- S65695
- Status last verified
- May 2022
- First submitted
- 6 Dec 2021
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral Ketone Administration During Inactivity-induced Muscle Atrophy and Retraining-induced Regeneration
- ClinicalTrials.gov ID
- NCT05398042
- Acronym / sponsor ID
- S65695
- Conditions
- Exercise, Healthy Male/Female Subjects
- Keywords
- Ketone, Inactivity-induced muscle atrophy, Retraining-induced regeneration
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 20 Jun 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 31 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Medium Chain Triglyceride (MCT) oilKetone placebo will be provided |
| Ketone | Experimental | Dietary Supplement: Ketone esterKetone esters will be provided |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketone esterA daily dose of 3x20g of ketone ester supplementation during a six week intervention period | Dietary supplement | Ketone |
| Medium Chain Triglyceride (MCT) oilA daily dose of 3x12.8g of MCT oil supplementation during a six week intervention period | Dietary supplement | Placebo |
Primary outcome
Exercise performance
Time frame: Day 0 - day 14 - day 28 - day 42
Changes in exercise performance as evaluated during a graded exercise test
Echo-Doppler measurement of femoral artery
Time frame: Day 0 - Day 14 - Day 28 - Day 42
Change in blood flow of arteria femoralis
Muscle volume
Time frame: Day 0 - Day 14 - Day 28 - Day 42
Change in volume of quadriceps evaluated by computed-tomography scan
Muscular functional capacity
Time frame: Day 0 - Day 14 - Day 28 - Day 42
Change in mean power produced during 30 unilateral knee extensions on a knee-extension apparatus
Skeletal muscle biopsies
Time frame: Day 0 - Day 14 - Day 28 - Day 42
Changes in myofibrillar protein synthesis
Skeletal muscle biopsies
Time frame: Day 0 - Day 14 - Day 28 - Day 42
Changes in connective tissue protein synthesis
Blood marker of collagen synthesis
Time frame: Day 0 - Day 14 - Day 28 - Day 42
Change in PINP (n-terminal peptide of pro-collagen I) concentration in blood
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ketone ester and Medium Chain Triglyceride (MCT) oil in people with Exercise and Healthy Male/Female Subjects, run by KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter Hespel, Prof. (+3216329091, peter.hespel@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise performance (time frame: Day 0 - day 14 - day 28 - day 42). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2022; AzTrials last refreshed its copy on 3 Nov 2026.