SleepPhase 2NCT05439720
Acute Effect of Exogenous Ketosis on Sleep Architecture Following Strenuous Exercise
A Phase 2 study testing Ketone ester and Exercise in people with Sleep, run by KU Leuven at 1 site in Belgium.
Trial summary
The aim of this study is to investigate the effect of oral ketone ester administration on sleep architecture. To investigate this, the investigators use a randomised, placebo-controlled, cross-over research design. The study comprises three experimental sessions, each separated by a one-week washout period. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Ketone ester and Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteBelgium
- Study dates
- 15 May 2022to 15 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males between 18 and 35 years old
- Recreational or competitive cyclists performing regularly cycling training sessions with an average training volume of more than 6 hours per week
- Good health status confirmed by a medical screening
- Body Mass Index (BMI) between 18 and 25
- Normal sleep pattern as assessed by the Pittsburgh Sleep Quality Index (PSQI)
- Moderate sleep chronotype, assessed by the Horne and Östberg questionnaire
Who cannot join
- Excessive daytime sleepiness as assessed by the Epworth scale
- Depression or anxiety as assessed by the Beck Depression Inventory and Beck Anxiety Inventory
- Night-shifts or travel across time zones in the month preceding the study
- Any kind of injury/pathology that is a contra-indication to perform high-intensity exercise
- Intake of any medication or nutritional supplement that is known to affect exercise performance or sleep
- Smoking
Show all 9Show fewer
- Involvement in elite athletic training at a semi-professional or professional level
- Current participation in another research trial
- Any other argument to believe that the subject is unlikely to successfully complete the full study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Effect of Exogenous Ketosis on Sleep Architecture Following Morning and Evening Strenuous Exercise
The aim of this study is to investigate the effect of oral ketone ester administration on sleep architecture. To investigate this, the investigators use a randomised, placebo-controlled, cross-over research design. The study comprises three experimental sessions, each separated by a one-week washout period. Two of the three experimental sessions consist of a 120 minutes cycling endurance training session (ET) two hours after breakfast and an evening high-intensity-interval training (HIIT) ending one hour before bedtime. After each training session, and 30 minutes before sleeptime, subjects receive a ketone ester or a control drink . To investigate the effects of strenuous exercise on sleep alone, an additional experimental session without exercise is added.
Before bedtime, a venous blood sample is taken to evaluate hormones playing an important role in sleep regulation. During the experimental sessions, the subjects sleep in a sleep facility to evaluate quality of sleep. Time spent in different sleep phases is measured via polysomnography (PSG). Urine output throughout the day and night will be collected for measurement of urinary excretion of adrenaline and noradrenaline as an index of intrinsic sympathetic activity.
- Conditions
- Sleep
- Being tested
- Ketone ester, Placebo, Exercise
- Keywords
- Ketone, Exercise, Sleep
- Medical subject headings
- Ketosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketone esterDietary supplement
A dose of 25g of ketone ester after each training session and 30 minutes before sleeptime. The total dose is 75g of ketone ester.
PlaceboDietary supplement
Collagen peptan (3g) mixed with 1 mM bitter sucrose octaacetate and 20ml of pure water. A dose of 25g of placebo drink is provided after each training session and 30 minutes before sleeptime. The total dose is 75g of placebo drink.
ExerciseBehavioural
A 120 minutes cycling endurance training session (ET) two hours after breakfast and an evening high-intensity-interval training (HIIT) ending one hour before bedtime
| Study group | Role | What they receive |
|---|---|---|
| Exercise and ketone | Experimental | Ketone ester is provided Receives: Dietary Supplement: Ketone ester; Behavioral: Exercise |
| Exercise and placebo | Placebo comparator | Placebo is provided Receives: Dietary Supplement: Placebo; Behavioral: Exercise |
| Non-exercise and placebo | Placebo comparator | Placebo is provided Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total sleep time
Change in total sleep time between conditions as evaluated with polysomnography
Measured: Between each condition, interspersed each time with a one-week wash-out period (The total duration of the measurements is two weeks)
Urinary nocturnal adrenaline excretion
Change in urinary nocturnal adrenaline excretion between conditions
Measured: Between each condition, interspersed each time with a one-week wash-out period (The total duration of the measurements is two weeks)
Urinary nocturnal noradrenaline excretion
Change in urinary nocturnal adrenaline excretion between conditions
Measured: Between each condition, interspersed each time with a one-week wash-out period (The total duration of the measurements is two weeks)
Secondary outcomes (5)
Total rapid-eye-movement sleep
Change in total rapid-eye-movement sleep between conditions as evaluated with polysomnography
Measured: Between each condition, interspersed each time with a one-week wash-out period (The total duration of the measurements is two weeks)
Total non-rapid-eye-movement sleep
Change in total non-rapid-eye-movement sleep between conditions as evaluated with polysomnography
Measured: Between each condition, interspersed each time with a one-week wash-out period (The total duration of the measurements is two weeks)
Total slow-wave sleep
Change in total slow-wave sleep between conditions as evaluated with polysomnography
Measured: Between each condition, interspersed each time with a one-week wash-out period (The total duration of the measurements is two weeks)
Plasma adrenaline concentration
Change in plasma adrenaline concentration between conditions
Measured: Between each condition, interspersed each time with a one-week wash-out period (The total duration of the measurements is two weeks)
Plasma noradrenaline concentration
Change in plasma noradrenaline concentration between conditions
Measured: Between each condition, interspersed each time with a one-week wash-out period (The total duration of the measurements is two weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start15 May 2022
- Primary completion1 Jul 2022 (estimated)
- Study completion15 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SleepStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 11 participants (actual)
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
- NCT05439720
- Sponsor's protocol ID
- S65394
- Status last verified
- Jun 2022
- First submitted
- 16 Jun 2022
- Last updated
- 30 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Robberechts R, Albouy G, Hespel P, Poffe C. Exogenous Ketosis Improves Sleep Efficiency and Counteracts the Decline in REM Sleep after Strenuous Exercise. Med Sci Sports Exerc. 2023 Nov 1;55(11):2064-2074. doi: 10.1249/MSS.0000000000003231. Epub 2023 Jun 1.
PubMed 37259248
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect of Exogenous Ketosis on Sleep Architecture Following Morning and Evening Strenuous Exercise
- ClinicalTrials.gov ID
- NCT05439720
- Acronym / sponsor ID
- S65394
- Conditions
- Sleep
- Keywords
- Ketone, Exercise, Sleep
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 11 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 15 May 2022 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 15 Aug 2022 (estimated)
- First posted
- 30 Jun 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 ester administration on sleep architecture. To investigate this, the investigators use a randomised, placebo-controlled, cross-over research design. The study comprises three experimental sessions, each separated by a one-week washout period. Two of the three experimental sessions consist of a 120 minutes cycling endurance training session (ET) two hours after breakfast and an evening high-intensity-interval training (HIIT) ending one hour before bedtime. After each training session, and 30 minutes before sleeptime, subjects receive a ketone ester or a control drink . To investigate the effects of strenuous exercise on sleep alone, an additional experimental session without exercise is added.
Before bedtime, a venous blood sample is taken to evaluate hormones playing an important role in sleep regulation. During the experimental sessions, the subjects sleep in a sleep facility to evaluate quality of sleep. Time spent in different sleep phases is measured via polysomnography (PSG). Urine output throughout the day and night will be collected for measurement of urinary excretion of adrenaline and noradrenaline as an index of intrinsic sympathetic activity.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exercise and ketone | Experimental | Dietary Supplement: Ketone ester, Behavioral: ExerciseKetone ester is provided |
| Exercise and placebo | Placebo comparator | Dietary Supplement: Placebo, Behavioral: ExercisePlacebo is provided |
| Non-exercise and placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo is provided |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Males between 18 and 35 years old
- Recreational or competitive cyclists performing regularly cycling training sessions with an average training volume of more than 6 hours per week
- Good health status confirmed by a medical screening
- Body Mass Index (BMI) between 18 and 25
- Normal sleep pattern as assessed by the Pittsburgh Sleep Quality Index (PSQI)
Key exclusion criteria (9 listed)
- Excessive daytime sleepiness as assessed by the Epworth scale
- Depression or anxiety as assessed by the Beck Depression Inventory and Beck Anxiety Inventory
- Night-shifts or travel across time zones in the month preceding the study
- Any kind of injury/pathology that is a contra-indication to perform high-intensity exercise
- Intake of any medication or nutritional supplement that is known to affect exercise performance or sleep
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 dose of 25g of ketone ester after each training session and 30 minutes before sleeptime. The total dose is 75g of ketone ester. | Dietary supplement | Exercise and ketone |
| PlaceboCollagen peptan (3g) mixed with 1 mM bitter sucrose octaacetate and 20ml of pure water. A dose of 25g of placebo drink is provided after each training session and 30 minutes before sleeptime. The total dose is 75g of placebo drink. | Dietary supplement | Exercise and placebo, Non-exercise and placebo |
| ExerciseA 120 minutes cycling endurance training session (ET) two hours after breakfast and an evening high-intensity-interval training (HIIT) ending one hour before bedtime | Behavioural | Exercise and ketone, Exercise and placebo |
Primary outcome
Total sleep time
Time frame: Between each condition, interspersed each time with a one-week wash-out period (The total duration of the measurements is two weeks)
Change in total sleep time between conditions as evaluated with polysomnography
Urinary nocturnal adrenaline excretion
Time frame: Between each condition, interspersed each time with a one-week wash-out period (The total duration of the measurements is two weeks)
Change in urinary nocturnal adrenaline excretion between conditions
Urinary nocturnal noradrenaline excretion
Time frame: Between each condition, interspersed each time with a one-week wash-out period (The total duration of the measurements is two weeks)
Change in urinary nocturnal adrenaline excretion between conditions
5 secondary outcomes
Total rapid-eye-movement sleep
Time frame: Between each condition, interspersed each time with a one-week wash-out period (The total duration of the measurements is two weeks)
Total non-rapid-eye-movement sleep
Time frame: Between each condition, interspersed each time with a one-week wash-out period (The total duration of the measurements is two weeks)
Total slow-wave sleep
Time frame: Between each condition, interspersed each time with a one-week wash-out period (The total duration of the measurements is two weeks)
Plasma adrenaline concentration
Time frame: Between each condition, interspersed each time with a one-week wash-out period (The total duration of the measurements is two weeks)
Plasma noradrenaline concentration
Time frame: Between each condition, interspersed each time with a one-week wash-out period (The total duration of the measurements is two weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
- Derived from this study: PubMed 37259248Robberechts R, Albouy G, Hespel P, Poffe C. Exogenous Ketosis Improves Sleep Efficiency and Counteracts the Decline in REM Sleep after Strenuous Exercise. Med Sci Sports Exerc. 2023 Nov 1;55(11):2064-2074. doi: 10.1249/MSS.0000000000003231. Epub 2023 Jun 1.
- Individual participant dataSharing planned: Undecided
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Healthy Adult Participants
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Exercise in people with Sleep, 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 6 inclusion and 9 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 30 Jun 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total sleep time (time frame: Between each condition, interspersed each time with a one-week wash-out period (The total duration of the measurements is two weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05439720, which also lists 1 linked publication.
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 30 Jun 2022.