KetosisNCT06060093
Effect of Ketone Ester Supplementation on Sleep and Recovery in Hypoxia
A study testing Ketone ester in people with Ketosis and Hypoxia, run by KU Leuven at 1 site in Belgium.
Trial summary
This study specifically aims to elucidate the effects of IEK on sleep and recuperation in hypoxia, after training in normoxia. These conditions are in line with the widely applied live-high train-low strategy. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- What is being tested?
- Ketone ester
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Feb 2023to 31 Mar 2023
- Phase
- Interventional
- 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
- Written informed consent must be obtained prior to any experimental procedures
- Males between 18 and 35 years old
- Recreational or competitive cyclists performing regular 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
- Moderate sleep chronotype (extreme morning and evening chronotypes will be excluded), assessed by the Horne and Östberg questionnaire
Who cannot join
- Any kind of injury/pathology that is a contra-indication for hypoxic exposure and/or to perform high-intensity exercise, evaluated by a sport medical screening
- Intake of any medication or nutritional supplement that is known to affect exercise, performance or sleep. Intake will be assessed during recruitment and the sport medical screening.
- Intake of analgesics, anti-inflammatory agents, or supplementary anti-oxidants, from 2 weeks prior to the start of the study.
- Recent residence or training under hypoxia; more than 7 days exposure to altitude > 1500m during the last 3 months preceding the study.
- Night-shifts or travel across time zones in the month preceding the study
- Blood donation within 3 months prior to the start of the study
Show all 13Show fewer
- Smoking
- More than 3 alcoholic beverages per day
- Pre-existing, diagnosed psychiatric conditions or diagnosed anxiety
- Excessive daytime sleepiness as assessed by the Epworth scale
- Depression or anxiety as assessed by the Beck Depression Inventory and Beck Anxiety Inventory. Only a score in the range of 'normal ups and downs' (score 1-10) for depression or 'minimal anxiety' (score 0-7) for anxiety are tolerated.
- History of addiction or excessive caffeine/alcohol consumption assessed by a questionnaire
- 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
This study specifically aims to elucidate the effects of IEK on sleep and recuperation in hypoxia, after training in normoxia. These conditions are in line with the widely applied live-high train-low strategy. Moreover, blood and tissue oxygenation status, as well as cerebral blood flow and cognitive function will be assessed.
Read the detailed description
During training stages in order to prepare for an important event, sleep and recuperation are almost equally important as the appropriate training strategy. This training strategy often consists of living-high (sleeping at -stimulated- altitude) and training low (training at sea level). A decreased oxygen availability, also known as hypoxia, however often disrupts sleep quality and thus compromises the overall training efficiency. Ketones are recently found to improve sleep quality, thus potentially playing a pivotal role in altitude training. Therefore, the investigators want to evaluate the effects of ketones on sleep in hypoxia, after training in normoxia. Moreover, the effect on a performance test, during a simulated 30 min time trial on the next morning, will be investigated. During this protocol, cerebral blood flow will be assessed, as well as ventilation, blood and tissue oxygen status, heart rate variability, and cognitive function.
- Being tested
- Placebo, Ketone ester
- Keywords
- Exercise, Ketones, Living-high Training-low
- Medical subject headings
- Ketosis, Hypoxia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Water, 5% collagen(w/w), octoacetate (1 mM)
Ketone esterDietary supplement
A total of 75g ketone ester supplementation will be administered in 3 bouts of 25g in order to establish intermittent exogenous ketosis: twice immediately after training, and one 30 minutes before sleep. The ketone ester used is (R)-3-hydroxybutyl (R)-3-hydroxybutyrate
| Study group | Role | What they receive |
|---|---|---|
| Normoxia - placebo | Placebo comparator | Both training and sleep in normoxia, supplemented with placebo Receives: Dietary Supplement: Placebo |
| Hypoxia - placebo | Experimental | Training in normoxia and sleep in hypoxia, supplemented with placebo Receives: Dietary Supplement: Placebo |
| Hypoxia - ketones | Experimental | Training in normoxia and sleep in hypoxia, supplemented with ketones Receives: Dietary Supplement: Ketone ester |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of different sleep stages
Measured using polysomnography
Measured: Throughout the entire duration of the night, up to 9 hours after individual bedtime
Exercise performance
Measured as the average power output (W) during a 30 minutes time trial
Measured: 30 minutes on the second morning of the protocol
Change in nocturnal oxygen saturation
Measured using pulse oximetry
Measured: Throughout the entire duration of the night, up to 9 hours after individual bedtime
Absolute amount of nocturnal urinary catecholamine excretion
Measured using ELISA of collected nocturnal urine
Measured: Subjects empty bladder before sleep and urine will be collected throughout the entire duration of the night, up to 9 hours after individual bedtime and in the morning immediately after waking up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start20 Feb 2023
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
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 KetosisStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 1 session with both training and sleep in normoxia, supplemented with placebo (NPL) 1 session with training in normoxia, sleep in hypoxia, supplemented with placebo (HPL) 1 session with training in normoxia, sleep in hypoxia, supplemented with ketones (HKE)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chiel Poffé, KU Leuven
- Investigators
- Chiel Poffé, Dr., Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06060093
- Sponsor's protocol ID
- S67089
- Status last verified
- Sep 2023
- First submitted
- 29 Aug 2023
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stalmans M, Tominec D, Robberechts R, Lauriks W, Ramaekers M, Debevec T, Poffe C. A Single Night in Hypoxia Either with or without Ketone Ester Ingestion Reduces Sleep Quality without Impacting Next-Day Exercise Performance. Med Sci Sports Exerc. 2025 Apr 1;57(4):807-819. doi: 10.1249/MSS.0000000000003604. Epub 2024 Nov 18.
PubMed 39809236
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ketone Ester Supplementation on Sleep and Recovery in Hypoxia
- ClinicalTrials.gov ID
- NCT06060093
- Acronym / sponsor ID
- S67089
- Keywords
- Exercise, Ketones, Living-high Training-low
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 29 Sep 2023 (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.
This study specifically aims to elucidate the effects of IEK on sleep and recuperation in hypoxia, after training in normoxia. These conditions are in line with the widely applied live-high train-low strategy. Moreover, blood and tissue oxygenation status, as well as cerebral blood flow and cognitive function will be assessed.
Detailed description
During training stages in order to prepare for an important event, sleep and recuperation are almost equally important as the appropriate training strategy. This training strategy often consists of living-high (sleeping at -stimulated- altitude) and training low (training at sea level). A decreased oxygen availability, also known as hypoxia, however often disrupts sleep quality and thus compromises the overall training efficiency. Ketones are recently found to improve sleep quality, thus potentially playing a pivotal role in altitude training. Therefore, the investigators want to evaluate the effects of ketones on sleep in hypoxia, after training in normoxia. Moreover, the effect on a performance test, during a simulated 30 min time trial on the next morning, will be investigated. During this protocol, cerebral blood flow will be assessed, as well as ventilation, blood and tissue oxygen status, heart rate variability, and cognitive function.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- 1 session with both training and sleep in normoxia, supplemented with placebo (NPL) 1 session with training in normoxia, sleep in hypoxia, supplemented with placebo (HPL) 1 session with training in normoxia, sleep in hypoxia, supplemented with ketones (HKE)
| Arm | Type | Receives |
|---|---|---|
| Normoxia - placebo | Placebo comparator | Dietary Supplement: PlaceboBoth training and sleep in normoxia, supplemented with placebo |
| Hypoxia - placebo | Experimental | Dietary Supplement: PlaceboTraining in normoxia and sleep in hypoxia, supplemented with placebo |
| Hypoxia - ketones | Experimental | Dietary Supplement: Ketone esterTraining in normoxia and sleep in hypoxia, supplemented with ketones |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Written informed consent must be obtained prior to any experimental procedures
- Males between 18 and 35 years old
- Recreational or competitive cyclists performing regular 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
Key exclusion criteria (13 listed)
- Any kind of injury/pathology that is a contra-indication for hypoxic exposure and/or to perform high-intensity exercise, evaluated by a sport medical screening
- Intake of any medication or nutritional supplement that is known to affect exercise, performance or sleep. Intake will be assessed during recruitment and the sport medical screening.
- Intake of analgesics, anti-inflammatory agents, or supplementary anti-oxidants, from 2 weeks prior to the start of the study.
- Recent residence or training under hypoxia; more than 7 days exposure to altitude > 1500m during the last 3 months preceding the study.
- Night-shifts or travel across time zones in the month preceding the study
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 |
|---|---|---|
| PlaceboWater, 5% collagen(w/w), octoacetate (1 mM) | Dietary supplement | Hypoxia - placebo, Normoxia - placebo |
| Ketone esterA total of 75g ketone ester supplementation will be administered in 3 bouts of 25g in order to establish intermittent exogenous ketosis: twice immediately after training, and one 30 minutes before sleep. The ketone ester used is (R)-3-hydroxybutyl (R)-3-hydroxybutyrate | Dietary supplement | Hypoxia - ketones |
Primary outcome
Duration of different sleep stages
Time frame: Throughout the entire duration of the night, up to 9 hours after individual bedtime
Measured using polysomnography
Exercise performance
Time frame: 30 minutes on the second morning of the protocol
Measured as the average power output (W) during a 30 minutes time trial
Change in nocturnal oxygen saturation
Time frame: Throughout the entire duration of the night, up to 9 hours after individual bedtime
Measured using pulse oximetry
Absolute amount of nocturnal urinary catecholamine excretion
Time frame: Subjects empty bladder before sleep and urine will be collected throughout the entire duration of the night, up to 9 hours after individual bedtime and in the morning immediately after waking up
Measured using ELISA of collected nocturnal urine
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- Derived from this study: PubMed 39809236Stalmans M, Tominec D, Robberechts R, Lauriks W, Ramaekers M, Debevec T, Poffe C. A Single Night in Hypoxia Either with or without Ketone Ester Ingestion Reduces Sleep Quality without Impacting Next-Day Exercise Performance. Med Sci Sports Exerc. 2025 Apr 1;57(4):807-819. doi: 10.1249/MSS.0000000000003604. Epub 2024 Nov 18.
- Individual participant dataSharing planned: No
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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.
Chiel Poffé, Dr. principal investigator
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketone ester in people with Ketosis and Hypoxia, 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 7 inclusion and 13 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: finished, as of the sponsor's last update on 29 Sep 2023. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Duration of different sleep stages (time frame: Throughout the entire duration of the night, up to 9 hours after individual bedtime). The study lists 4 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 NCT06060093, 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 29 Sep 2023.