KetosisNCT05588427
Effect of Ketone Ester Supplementation on Hypoxic Tolerance
A study testing Ketone ester in people with Ketosis and Hypoxia, run by KU Leuven at 1 site in Belgium.
Trial summary
This WP specifically aims to elucidate the effects of IEK on hypoxic tolerance and the development and severity of AMS symptoms, blood and tissue oxygenation status, as well as sleep quality during an episode of acute exposure to severe hypoxia. 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
- 16 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Nov 2022to 31 Dec 2022
- 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
- Males or females between 18 and 35 years old
- Body Mass Index (BMI) between 18 and 25
- Physically fit and regularly involved in physical activity (2-5 exercise sessions of > 30min per week)
- Good health status confirmed by a medical screening
- Non smoking
- Normal sleep pattern as assessed by the Pittsburgh Sleep Quality Index (PSQI, appendix 2)
Who cannot join
- Any kind of injury/pathology that is a contra-indication for hypoxic exposure and/or to perform high-intensity exercise
- Intake of any medication or nutritional supplement that is known to affect exercise, performance or sleep
- 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 a period of 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 10Show fewer
- Smoking
- More than 3 alcoholic beverages per day
- Involvement in elite athletic training at a semi-professional or professional level
- 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 WP specifically aims to elucidate the effects of IEK on hypoxic tolerance and the development and severity of AMS symptoms, blood and tissue oxygenation status, as well as sleep quality during an episode of acute exposure to severe hypoxia.
Read the detailed description
Acute altitude exposure impairs exercise tolerance and performance, decreases the rate of maximal oxygen uptake (V̇O2max), cognitive function and sleep quality, and often also induces symptoms of acute mountain sickness (AMS). Previous studies have clearly indicated that ketone bodies exert a neuroprotective effect under hypoxic-ischemic conditions as well as improve hypoxic tolerance in rodents. In support of these earlier observations, recent pilot experiments in young volunteers in our laboratory provide proof of concept that IEK can attenuate oxygen desaturation during exercise in hypoxia. Therefore, given that impaired exercise tolerance in hypoxia is primarily due to impaired oxidative energy production in active tissues (brain and muscle), we hypothesize that IEK can increase blood and tissue (muscle and brain) oxygenation status in hypoxia and thereby enhance global hypoxic tolerance, as well as improve exercise tolerance and endurance exercise performance.
- Being tested
- Ketone ester, Placebo
- Keywords
- Acute Mountain Sickness, Sleep, Cognitive Decline
- Medical subject headings
- Ketosis, Hypoxia, Altitude Sickness, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketone esterDietary supplement
A total of 240g ketone ester supplementation will be provided in one of the 28h experimental sessions in order to establish intermittent exogenous ketosis. Sucralose (5% w/w) is added to the ketone ester (R)-3-hydroxybutyl (R)-3-hydroxybutyrate
PlaceboDietary supplement
Water, 5% sucralose (w/w), octaacetate (1 mM)
| Study group | Role | What they receive |
|---|---|---|
| Ketone group | Experimental | Ketone esters will be provided Receives: Dietary Supplement: Ketone ester |
| Placebo group | Placebo comparator | Ketone placebo will be provided Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in incidence of acute mountain sickness symptoms
Scored by Lake Louise Scoring system
Measured: Hour 0 - Hour 4 - Hour 10 - Hour 24 - Hour 28
Change in oxygenation status of brain, blood, muscle
Measured by NIRS, pulse oximetry, blood samples
Measured: Hour 1 - Hour 4 - Hour 10 - Hour 24 - Hour 28
Change in cerebral blood flow
Measured using duplex ultrasound
Measured: Hour 1 - Hour 4 - Hour 10 - Hour 24 - Hour 28
Time in hypoxia
Total time that subjects were able to comply to the experimental protocol and supplementation protocol
Measured: From start of hypoxic exposure until subjects are too sick to comply to (supplementation) protocol or until end of protocol, up to 29 hours
Secondary outcomes (1)
Sleep quality
Measured using polysomnography
Measured: Throughout the entire duration of the night, up to 9 hours after individual bedtime
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start15 Nov 2022
- Primary completion20 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 ketone ester supplementation and 1 session with taste and viscosity matched placebo
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 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
- NCT05588427
- Sponsor's protocol ID
- S66320
- Status last verified
- Aug 2023
- First submitted
- 14 Oct 2022
- Last updated
- 5 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ketone Ester Supplementation on Hypoxic Tolerance
- ClinicalTrials.gov ID
- NCT05588427
- Acronym / sponsor ID
- S66320
- Keywords
- Acute Mountain Sickness, Sleep, Cognitive Decline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 20 Oct 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.
This WP specifically aims to elucidate the effects of IEK on hypoxic tolerance and the development and severity of AMS symptoms, blood and tissue oxygenation status, as well as sleep quality during an episode of acute exposure to severe hypoxia.
Detailed description
Acute altitude exposure impairs exercise tolerance and performance, decreases the rate of maximal oxygen uptake (V̇O2max), cognitive function and sleep quality, and often also induces symptoms of acute mountain sickness (AMS). Previous studies have clearly indicated that ketone bodies exert a neuroprotective effect under hypoxic-ischemic conditions as well as improve hypoxic tolerance in rodents. In support of these earlier observations, recent pilot experiments in young volunteers in our laboratory provide proof of concept that IEK can attenuate oxygen desaturation during exercise in hypoxia. Therefore, given that impaired exercise tolerance in hypoxia is primarily due to impaired oxidative energy production in active tissues (brain and muscle), we hypothesize that IEK can increase blood and tissue (muscle and brain) oxygenation status in hypoxia and thereby enhance global hypoxic tolerance, as well as improve exercise tolerance and endurance exercise performance.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 1 session with ketone ester supplementation and 1 session with taste and viscosity matched placebo
| Arm | Type | Receives |
|---|---|---|
| Ketone group | Experimental | Dietary Supplement: Ketone esterKetone esters will be provided |
| Placebo group | Placebo comparator | Dietary Supplement: PlaceboKetone placebo will be provided |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Males or females between 18 and 35 years old
- Body Mass Index (BMI) between 18 and 25
- Physically fit and regularly involved in physical activity (2-5 exercise sessions of > 30min per week)
- Good health status confirmed by a medical screening
- Non smoking
Key exclusion criteria (10 listed)
- Any kind of injury/pathology that is a contra-indication for hypoxic exposure and/or to perform high-intensity exercise
- Intake of any medication or nutritional supplement that is known to affect exercise, performance or sleep
- 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 a period of 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 |
|---|---|---|
| Ketone esterA total of 240g ketone ester supplementation will be provided in one of the 28h experimental sessions in order to establish intermittent exogenous ketosis. Sucralose (5% w/w) is added to the ketone ester (R)-3-hydroxybutyl (R)-3-hydroxybutyrate | Dietary supplement | Ketone group |
| PlaceboWater, 5% sucralose (w/w), octaacetate (1 mM) | Dietary supplement | Placebo group |
Primary outcome
Change in incidence of acute mountain sickness symptoms
Time frame: Hour 0 - Hour 4 - Hour 10 - Hour 24 - Hour 28
Scored by Lake Louise Scoring system
Change in oxygenation status of brain, blood, muscle
Time frame: Hour 1 - Hour 4 - Hour 10 - Hour 24 - Hour 28
Measured by NIRS, pulse oximetry, blood samples
Change in cerebral blood flow
Time frame: Hour 1 - Hour 4 - Hour 10 - Hour 24 - Hour 28
Measured using duplex ultrasound
Time in hypoxia
Time frame: From start of hypoxic exposure until subjects are too sick to comply to (supplementation) protocol or until end of protocol, up to 29 hours
Total time that subjects were able to comply to the experimental protocol and supplementation protocol
1 secondary outcome
Sleep quality
Time frame: Throughout the entire duration of the night, up to 9 hours after individual bedtime
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 5 Sep 2023.
- 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 6 inclusion and 10 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 5 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?
Change in incidence of acute mountain sickness symptoms (time frame: Hour 0 - Hour 4 - Hour 10 - Hour 24 - Hour 28). 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?
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 5 Sep 2023.