KetosisNCT06472427
The Effect of Butanediol Ingestion on Skeletal Muscle Angiogenesis in Hypoxia
A study testing Normoxic recovery and ketones (NKE) and Hypoxic recovery and ketones (HKE) 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 intermittent exogenous ketosis (IEK) as well as hypoxia on muscular pro-angiogenic factors- after a 60-min HIIT bout in normoxia. Moreover, blood and muscle oxygenation status, as well as peripheral blood flow and cognitive function will be assessed. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Ketosis, Hypoxia, Angiogenesis
- What is being tested?
- Normoxic recovery and ketones (NKE) and Hypoxic recovery and ketones (HKE)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jul 2024to 30 Jul 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
- Written informed consent must be obtained prior to any experimental procedures
- Biological male or biological females using oral contraception 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 kg/m2
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 or performance. Intake will be assessed during recruitment and the sport medical screening.
- Intake of analgesics, anti-inflammatory agents, or supplementary anti-oxidants, within two weeks of study participation.
- Recent residence or training under hypoxia; more than 7 days exposure to altitude > 1500 m during the 3 months preceding the study.
- Blood donation within 3 months of study participation.
- Habitual smoking
Show all 11Show fewer
- Pre-existing, diagnosed psychiatric conditions or anxiety
- Females that are pregnant or are planning to be pregnant before the end of the study (end of May 2024)
- Depression or anxiety as assessed by the Beck Depression Inventory 25 (Appendix 2) and Beck Anxiety Inventory 26 (Appendix 3). 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 (Appendix 4).
- Any other reason that might pose undue risk to the participant, or introduce bias into the study outcomes, at the discretion of the research team.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Acute Effect of (R)-1,3-butanediol Ingestion on Post-exercise Skeletal Muscle Angiogenesis in Healthy Adults Under Normoxic and Hypoxic Conditions.
This study specifically aims to elucidate the effects of intermittent exogenous ketosis (IEK) as well as hypoxia on muscular pro-angiogenic factors- after a 60-min HIIT bout in normoxia. Moreover, blood and muscle oxygenation status, as well as peripheral blood flow and cognitive function will be assessed.
Read the detailed description
After an exercise bout, angiogenesis is incredibly important in the recovery process as an increased number of capillaries enables higher metabolite transport to and from the working muscle. Often, a training strategy consists of living-high (sleeping at -stimulated- altitude) and training low (training at sea level). A decreased oxygen availability, also known as hypoxia, however poses an additional stress on the human body, potentially compromising the overall training efficiency. Ketones are recently found to increase angiogenesis in response to overload training (increased skeletal muscle capillarization and VEGF content) and to increase serum EPO concentrations. Therefore, the investigators want to evaluate the isolated and interactive effects of both ketones and hypoxia on post-exercise recovery and factors implicated in skeletal muscle angiogenesis, after training in normoxia. Moreover, a performance test will be performed after 7h of hypoxic or normoxic recovery by means of a simulated 15 min all-out time trial. During the 7h post-exercise window, biological samples are collected (muscle biopsies, venous blood samples, urine, capillary blood samples). Moreover, blood and muscle oxygenation, peripheral blood flow and cognitive function are assessed at regular timepoints.
- Conditions
- Ketosis, Hypoxia, Angiogenesis
- Being tested
- Normoxic recovery and placebo (NPL), Normoxic recovery and ketones (NKE), Hypoxic recovery and placebo (HPL), Hypoxic recovery and ketones (HKE)
- Keywords
- Exercise, Recovery, 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.
Normoxic recovery and placebo (NPL)Dietary supplement
Altitude: sea level Dietary supplement: placebo. Water: 98.3% w/w Bitter flavour type: 0.7% w/w Monk fruit extract: 0.04% w/w Tasteva: 0.03% w/w Citric acid: 0.6% w/w Flavor blend: 0.02% w/w Bitter masking flavour: 0.2% w/w Passion fruit flavour: 0.005% w/w
Normoxic recovery and ketones (NKE)Dietary supplement
Altitude: sea level Dietary supplement: Commercially available Ketone-IQ butanediol drink R-1,3-butanediol: 28.6% w/v in water
Hypoxic recovery and placebo (HPL)Dietary supplement
Altitude: 3,000m (simulated) Dietary supplement: placebo. Water: 98.3% w/w Bitter flavour type: 0.7% w/w Monk fruit extract: 0.04% w/w Tasteva: 0.03% w/w Citric acid: 0.6% w/w Flavor blend: 0.02% w/w Bitter masking flavour: 0.2% w/w Passion fruit flavour: 0.005% w/w
Hypoxic recovery and ketones (HKE)Dietary supplement
Altitude: 3,000m (simulated) Dietary supplement: Commercially available Ketone-IQ butanediol drink R-1,3-butanediol: 28.6% w/v in water
| Study group | Role | What they receive |
|---|---|---|
| 1 session with normoxic post-exercise recovery, supplemented with placebo (NPL) | Placebo comparator | Normoxic training, followed by normoxic recovery with placebo supplements Receives: Dietary Supplement: Normoxic recovery and placebo (NPL) |
| 1 session with normoxic post-exercise recovery, supplemented with ketones (NKE) | Experimental | Normoxic training, followed by normoxic recovery with ketone supplements Receives: Dietary Supplement: Normoxic recovery and ketones (NKE) |
| 1 session with hypoxic post-exercise recovery, supplemented with placebo (HPL) | Experimental | Normoxic training, followed by hypoxic (simulated altitude of 3000m) recovery with placebo supplements Receives: Dietary Supplement: Hypoxic recovery and placebo (HPL) |
| 1 session with hypoxic post-exercise recovery, supplemented with ketones (HKE) | Experimental | Normoxic training, followed by hypoxic (simulated altitude of 3000m) recovery with ketone supplements Receives: Dietary Supplement: Hypoxic recovery and ketones (HKE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-exercise muscle VEGF mRNA expression
Measured using PCR on collected muscle biopsies
Measured: Muscle biopsies are collected 10 minutes after the end of training as well as 3 hours later.
Post-exercise serum EPO concentrations
Measured using ELISA on collected serum samples
Measured: Venous blood samples are collected 10 minutes after the end of training as well as 3 hours, 5 hours and 7 hours later.
Secondary outcomes (6)
Change in muscular VEGF concentration
Measured using Western Blotting on muscle biopsies
Measured: Muscle biopsies are collected 10 minutes after the end of training as well as 3 hours later.
Change in serum VEGF concentration
Measured using ELISA on collected serum samples
Measured: Venous blood samples are collected immediately (5 minutes) after the end of training, as well as 3hours, 5hours and 7hours later..
Change in blood oxygenation
Measured using pulse oximetry with a sensor on the forehead
Measured: Continuously measured starting 30 minutes after the end of exerciseuntil 7.5 hours later
Change in skeletal muscle oxygenation
Measured using NIRS with a sensor on the belly of the m. vastus lateralis (skeletal muscle)
Measured: Measured during resting measurements performed 30 minutes, 3hours and 30minutes as well as 6hours and 30minutes after the end of training.
Change in peripheral blood flow
Measured using duplex ultrasonography
Measured: Measured during resting measurements performed 30 minutes, 3hours and 30minutes as well as 6hours and 30minutes after the end of the training
Exercise performance
Measured as the average power output (W) during a 15 minutes all-out time trial
Measured: Performed 7hours and 30minutes after the end of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start1 Jul 2024
- Primary completion30 Jul 2024
- Study completion30 Jul 2024
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.
- 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 normoxic post-exercise recovery, supplemented with placebo (NPL) 1 session with normoxic post-exercise recovery, supplemented with ketones (NKE) 1 session with hypoxic post-exercise recovery, supplemented with placebo (HPL) 1 session with hypoxic post-exercise recovery, supplemented with ketones (HKE)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 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, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06472427
- Sponsor's protocol ID
- S68402
- Status last verified
- Sep 2024
- First submitted
- 30 May 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 Acute Effect of (R)-1,3-butanediol Ingestion on Post-exercise Skeletal Muscle Angiogenesis in Healthy Adults Under Normoxic and Hypoxic Conditions.
- ClinicalTrials.gov ID
- NCT06472427
- Acronym / sponsor ID
- S68402
- Conditions
- Ketosis, Hypoxia, Angiogenesis
- Keywords
- Exercise, Recovery, Living high training low
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 25 Jun 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 specifically aims to elucidate the effects of intermittent exogenous ketosis (IEK) as well as hypoxia on muscular pro-angiogenic factors- after a 60-min HIIT bout in normoxia. Moreover, blood and muscle oxygenation status, as well as peripheral blood flow and cognitive function will be assessed.
Detailed description
After an exercise bout, angiogenesis is incredibly important in the recovery process as an increased number of capillaries enables higher metabolite transport to and from the working muscle. Often, a training strategy consists of living-high (sleeping at -stimulated- altitude) and training low (training at sea level). A decreased oxygen availability, also known as hypoxia, however poses an additional stress on the human body, potentially compromising the overall training efficiency. Ketones are recently found to increase angiogenesis in response to overload training (increased skeletal muscle capillarization and VEGF content) and to increase serum EPO concentrations. Therefore, the investigators want to evaluate the isolated and interactive effects of both ketones and hypoxia on post-exercise recovery and factors implicated in skeletal muscle angiogenesis, after training in normoxia. Moreover, a performance test will be performed after 7h of hypoxic or normoxic recovery by means of a simulated 15 min all-out time trial. During the 7h post-exercise window, biological samples are collected (muscle biopsies, venous blood samples, urine, capillary blood samples). Moreover, blood and muscle oxygenation, peripheral blood flow and cognitive function are assessed at regular timepoints.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- 1 session with normoxic post-exercise recovery, supplemented with placebo (NPL) 1 session with normoxic post-exercise recovery, supplemented with ketones (NKE) 1 session with hypoxic post-exercise recovery, supplemented with placebo (HPL) 1 session with hypoxic post-exercise recovery, supplemented with ketones (HKE)
| Arm | Type | Receives |
|---|---|---|
| 1 session with normoxic post-exercise recovery, supplemented with placebo (NPL) | Placebo comparator | Dietary Supplement: Normoxic recovery and placebo (NPL)Normoxic training, followed by normoxic recovery with placebo supplements |
| 1 session with normoxic post-exercise recovery, supplemented with ketones (NKE) | Experimental | Dietary Supplement: Normoxic recovery and ketones (NKE)Normoxic training, followed by normoxic recovery with ketone supplements |
| 1 session with hypoxic post-exercise recovery, supplemented with placebo (HPL) | Experimental | Dietary Supplement: Hypoxic recovery and placebo (HPL)Normoxic training, followed by hypoxic (simulated altitude of 3000m) recovery with placebo supplements |
| 1 session with hypoxic post-exercise recovery, supplemented with ketones (HKE) | Experimental | Dietary Supplement: Hypoxic recovery and ketones (HKE)Normoxic training, followed by hypoxic (simulated altitude of 3000m) recovery with ketone supplements |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Written informed consent must be obtained prior to any experimental procedures
- Biological male or biological females using oral contraception 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 kg/m2
Key exclusion criteria (11 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 or performance. Intake will be assessed during recruitment and the sport medical screening.
- Intake of analgesics, anti-inflammatory agents, or supplementary anti-oxidants, within two weeks of study participation.
- Recent residence or training under hypoxia; more than 7 days exposure to altitude > 1500 m during the 3 months preceding the study.
- Blood donation within 3 months of study participation.
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 |
|---|---|---|
| Normoxic recovery and placebo (NPL)Altitude: sea level Dietary supplement: placebo. Water: 98.3% w/w Bitter flavour type: 0.7% w/w Monk fruit extract: 0.04% w/w Tasteva: 0.03% w/w Citric acid: 0.6% w/w Flavor blend: 0.02% w/w Bitter masking flavour: 0.2% w/w Passion fruit flavour: 0.005% w/w | Dietary supplement | 1 session with normoxic post-exercise recovery, supplemented with placebo (NPL) |
| Normoxic recovery and ketones (NKE)Altitude: sea level Dietary supplement: Commercially available Ketone-IQ butanediol drink R-1,3-butanediol: 28.6% w/v in water | Dietary supplement | 1 session with normoxic post-exercise recovery, supplemented with ketones (NKE) |
| Hypoxic recovery and placebo (HPL)Altitude: 3,000m (simulated) Dietary supplement: placebo. Water: 98.3% w/w Bitter flavour type: 0.7% w/w Monk fruit extract: 0.04% w/w Tasteva: 0.03% w/w Citric acid: 0.6% w/w Flavor blend: 0.02% w/w Bitter masking flavour: 0.2% w/w Passion fruit flavour: 0.005% w/w | Dietary supplement | 1 session with hypoxic post-exercise recovery, supplemented with placebo (HPL) |
| Hypoxic recovery and ketones (HKE)Altitude: 3,000m (simulated) Dietary supplement: Commercially available Ketone-IQ butanediol drink R-1,3-butanediol: 28.6% w/v in water | Dietary supplement | 1 session with hypoxic post-exercise recovery, supplemented with ketones (HKE) |
Primary outcome
Post-exercise muscle VEGF mRNA expression
Time frame: Muscle biopsies are collected 10 minutes after the end of training as well as 3 hours later.
Measured using PCR on collected muscle biopsies
Post-exercise serum EPO concentrations
Time frame: Venous blood samples are collected 10 minutes after the end of training as well as 3 hours, 5 hours and 7 hours later.
Measured using ELISA on collected serum samples
6 secondary outcomes
Change in muscular VEGF concentration
Time frame: Muscle biopsies are collected 10 minutes after the end of training as well as 3 hours later.
Change in serum VEGF concentration
Time frame: Venous blood samples are collected immediately (5 minutes) after the end of training, as well as 3hours, 5hours and 7hours later..
Change in blood oxygenation
Time frame: Continuously measured starting 30 minutes after the end of exerciseuntil 7.5 hours later
Change in skeletal muscle oxygenation
Time frame: Measured during resting measurements performed 30 minutes, 3hours and 30minutes as well as 6hours and 30minutes after the end of training.
Change in peripheral blood flow
Time frame: Measured during resting measurements performed 30 minutes, 3hours and 30minutes as well as 6hours and 30minutes after the end of the training
Exercise performance
Time frame: Performed 7hours and 30minutes after the end of training
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 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 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 Normoxic recovery and ketones (NKE) and Hypoxic recovery and ketones (HKE) 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 5 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: finished, 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?
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?
Post-exercise muscle VEGF mRNA expression (time frame: Muscle biopsies are collected 10 minutes after the end of training as well as 3 hours later.). The study lists 2 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.