HypoxiaNCT06596083
The Effects of Ketone Ester Supplementation During a 5 Week Live High, Train Low Altitude Training Camp
A study testing Ketone ester supplement in people with Hypoxia and Exogenous Ketosis, run by KU Leuven at 1 site in Belgium.
Trial summary
This study aims to investigate the effects of post-exercise and pre-sleep exogenous ketosis via oral ketone ester supplementation during a 5 week simulated altitude training camp. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypoxia, Exogenous Ketosis
- What is being tested?
- Ketone ester supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteBelgium
- Study dates
- 10 Sep 2024to 15 Oct 2024
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Physically fit and regularly involved in physical activity (2-5h per week)
- Good health status confirmed by a medical screening
- Non-smoking
Who cannot join
- Any kind of injury/pathology that is a contra-indication to perform high-intensity exercise
- Any kind of injury/pathology that is a contra-indication for exposure to hypoxia
- Ongoing pregnancy or breastfeeding
- intake of any medication or nutritional supplement that is proven to affect exercise performance during the last month prior to the start of the study
- Involvement in elite athletic training at a semi-professional or professional level
- Exposure to altitudes higher than 1500 m during the 3 months prior to the start of the study
Show all 9Show fewer
- Blood ferritin levels below 30 ng/mL
- Current participation in another research trial
- Any other argument to believe that the subject is unlikely to succesfully complete the full study protocol
Trial locations and contacts
1 site in 1 country.
Chiel Poffé contact
Belgium1 site, 1 recruiting
- Recruiting
KU Leuven
Leuven, Vlaams-Brabant, 3000
Chiel Poffé, chiel.poffe@kuleuven.be
About this study
This study aims to investigate the effects of post-exercise and pre-sleep exogenous ketosis via oral ketone ester supplementation during a 5 week simulated altitude training camp.
Read the detailed description
Altitude training camps, where you train at sea level but live at altitude, have become a popular way for athletes to prepare for upcoming races or events. The main aim of such training camps is to benefit from the adaptations following prolonged hypoxic exposure (increased EPO concentrations leading to an increase in oxygen carrying capacity in the blood). Recently, ketone bodies have been shown to cause similar adaptations. Therefore, this study aims to investigate whether the combination of exogenous ketosis and an altitude training camp is more beneficial compared to an altitude training camp on its own.
Participants will follow a 5 week simulated altitude training camp where they spend 75 hours per week at altitude (2000-3000 meters), while taking ketone or placebo supplements after every training sessions and before going to sleep. During these 5 weeks, they will adhere to a prescribed training plan, consisting of 5 to 7 training sessions per week. Before, after and 1 week after the training camp, their exercise performance, EPO concentrations, hemoglobin mass and VO2max will be tested.
- Conditions
- Hypoxia, Exogenous Ketosis
- Being tested
- Placebo supplement, Ketone ester supplement
- Keywords
- Altitude training camp, Exercise, Live high, train low, EPO
- Medical subject headings
- Hypoxia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo supplementDietary supplement
oral supplement containing: 16.4 grams of medium chained triglycerides, 1mM or sucrose octaacetate and water
Ketone ester supplementDietary supplement
Oral supplement containing: 25 grams of pure (R)-3-hydroxybutyl-(R)-3-hydroxybutyrate ketone monoester drink
| Study group | Role | What they receive |
|---|---|---|
| Placebo Comparator | Placebo comparator | Training intervention: 5 weeks of live high, train low followed by an additional 1 week of reduced training (to simulate preparation for an upcoming event or race) Dietary intervention: placebo supplement Receives: Dietary Supplement: Placebo supplement |
| Experimental group | Experimental | Training intervention: 5 weeks of live high, train low followed by an additional 1 week of reduced training (to simulate preparation for an upcoming event or race) Dietary intervention: Ketone ester supplement Receives: Dietary Supplement: Ketone ester supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total hemoglobin mass
Using the optimized CO-re-breathing method, total hemoglobin mass will be estimated
Measured: Day 0, Day 35, Day 42
Skeletal muscle capillarization
Changes in muscle capillarization are measured using immunohistochemical anlyses
Measured: Day 0, Day 35, Day 42
Cycling exercise performance
maximal average power output during a 30 minute time trial, cycling efficiency test and repeated sprint test
Measured: Day 0, Day 35, Day 42
Secondary outcomes (4)
Maximal oxygen uptake (VO2max)
Using ergospirometry VO2max will be measured during a graded exercise test
Measured: Day 0, Day 35, Day 42
Change in peripheral blood flow
Measured using duplex ultrasonography
Measured: Day 0, Day 35, Day 42
Serum EPO concentrations
Serum EPO concentrations will be measured using a commercially available ELISA kit
Measured: Day 0, day1, week1, week2, week3, week4, week5, day35, day42
Sleep Architecture
Polysomnography will be used to measure sleep architecture
Measured: Day 0, day1, week 3, day35, day42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start10 Sep 2024 (estimated)
- Primary completion15 Oct 2024 (estimated)
- Study completion15 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxiaStudies 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
- Parallel groups
- Model description
- Participants will go through the entire 5 week training camp and 1 week follow up while taking either ketone ester supplements (KE) or an isocaloric placebo (CON).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chiel Poffé, KU Leuven
- Investigators
- Chiel Poffé, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06596083
- Sponsor's protocol ID
- S67562
- Status last verified
- Sep 2024
- First submitted
- 27 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Ketone Ester Supplementation During a 5 Week Live High, Train Low Altitude Training Camp
- ClinicalTrials.gov ID
- NCT06596083
- Acronym / sponsor ID
- S67562
- Conditions
- Hypoxia, Exogenous Ketosis
- Keywords
- Altitude training camp, Exercise, Live high, train low, EPO
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 10 Sep 2024 (estimated)
- Primary completion
- 15 Oct 2024 (estimated)
- Study completion
- 15 Oct 2024 (estimated)
- First posted
- 19 Sep 2024 (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 aims to investigate the effects of post-exercise and pre-sleep exogenous ketosis via oral ketone ester supplementation during a 5 week simulated altitude training camp.
Detailed description
Altitude training camps, where you train at sea level but live at altitude, have become a popular way for athletes to prepare for upcoming races or events. The main aim of such training camps is to benefit from the adaptations following prolonged hypoxic exposure (increased EPO concentrations leading to an increase in oxygen carrying capacity in the blood). Recently, ketone bodies have been shown to cause similar adaptations. Therefore, this study aims to investigate whether the combination of exogenous ketosis and an altitude training camp is more beneficial compared to an altitude training camp on its own.
Participants will follow a 5 week simulated altitude training camp where they spend 75 hours per week at altitude (2000-3000 meters), while taking ketone or placebo supplements after every training sessions and before going to sleep. During these 5 weeks, they will adhere to a prescribed training plan, consisting of 5 to 7 training sessions per week. Before, after and 1 week after the training camp, their exercise performance, EPO concentrations, hemoglobin mass and VO2max will be tested.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Participants will go through the entire 5 week training camp and 1 week follow up while taking either ketone ester supplements (KE) or an isocaloric placebo (CON).
| Arm | Type | Receives |
|---|---|---|
| Placebo Comparator | Placebo comparator | Dietary Supplement: Placebo supplementTraining intervention: 5 weeks of live high, train low followed by an additional 1 week of reduced training (to simulate preparation for an upcoming event or race) Dietary intervention: placebo supplement |
| Experimental group | Experimental | Dietary Supplement: Ketone ester supplementTraining intervention: 5 weeks of live high, train low followed by an additional 1 week of reduced training (to simulate preparation for an upcoming event or race) Dietary intervention: Ketone ester supplement |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Physically fit and regularly involved in physical activity (2-5h per week)
- Good health status confirmed by a medical screening
- Non-smoking
Key exclusion criteria (9 listed)
- Any kind of injury/pathology that is a contra-indication to perform high-intensity exercise
- Any kind of injury/pathology that is a contra-indication for exposure to hypoxia
- Ongoing pregnancy or breastfeeding
- intake of any medication or nutritional supplement that is proven to affect exercise performance during the last month prior to the start of the study
- Involvement in elite athletic training at a semi-professional or professional level
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 |
|---|---|---|
| Placebo supplementoral supplement containing: 16.4 grams of medium chained triglycerides, 1mM or sucrose octaacetate and water | Dietary supplement | Placebo Comparator |
| Ketone ester supplementOral supplement containing: 25 grams of pure (R)-3-hydroxybutyl-(R)-3-hydroxybutyrate ketone monoester drink | Dietary supplement | Experimental group |
Primary outcome
Total hemoglobin mass
Time frame: Day 0, Day 35, Day 42
Using the optimized CO-re-breathing method, total hemoglobin mass will be estimated
Skeletal muscle capillarization
Time frame: Day 0, Day 35, Day 42
Changes in muscle capillarization are measured using immunohistochemical anlyses
Cycling exercise performance
Time frame: Day 0, Day 35, Day 42
maximal average power output during a 30 minute time trial, cycling efficiency test and repeated sprint test
4 secondary outcomes
Maximal oxygen uptake (VO2max)
Time frame: Day 0, Day 35, Day 42
Change in peripheral blood flow
Time frame: Day 0, Day 35, Day 42
Serum EPO concentrations
Time frame: Day 0, day1, week1, week2, week3, week4, week5, day35, day42
Sleep Architecture
Time frame: Day 0, day1, week 3, day35, day42
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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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 contact
Chiel Poffé 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 supplement in people with Hypoxia and Exogenous Ketosis, 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 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 19 Sep 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wout Lauriks (+32474360778, wout.lauriks@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total hemoglobin mass (time frame: Day 0, Day 35, Day 42). 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?
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 19 Sep 2024.