ExerciseNCT04579770
Effect of Oral Ketone and Sodium Bicarbonate Administration During Endurance Exercise in Hypoxia
A study testing Ketone ester and Sodium bicarbonate in people with Exercise and Hypoxia, run by Jozef Stefan Institute at 1 site in Belgium.
Trial summary
This study is investigating the effects of oral ketone and sodium bicarbonate administration on physiological and metabolic parameters during cycling endurance exercise in hypoxia. Ketone body supplementation is commonly used among elite endurance athletes that also compete in the hypoxia (at altitude). 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 and Sodium bicarbonate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteBelgium
- Study dates
- 4 Nov 2020to 15 Dec 2020
- 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 between 18 and 35 years old
- Recreational or competitive cyclist performing regularly cycling training sessions of at least 4 hours, with an average training volume of more than 6 hours per week
- Good health status confirmed by a medical screening
- VO2max higher than 55 ml.min-1.kg-1
- Body Mass Index (BMI) between 18 and 25
Who cannot join
- 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
- Intake of analgesics, anti-inflammatory agents, or supplementary anti-oxidants, from 2 weeks prior to the start of the study.
- Blood donation within 3 months prior to the start of the study
- Smoking
- More than 3 alcoholic beverages per day, including a maximum of one glass of wine per day
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: Effect of Oral Ketone and Sodium Bicarbonate Administration on Physiological and Metabolic Parameters During Endurance Exercise in Hypoxia
This study is investigating the effects of oral ketone and sodium bicarbonate administration on physiological and metabolic parameters during cycling endurance exercise in hypoxia. Ketone body supplementation is commonly used among elite endurance athletes that also compete in the hypoxia (at altitude). To-date effects of ketones have only been investigated in normoxia and the data in hypoxia is lacking. Hence, we want to investigate the effect of oral ketone ester intake with and without additional sodium bicarbonate (NaHCO3) ingestion on i) blood-acid base balance and ii) exercise performance during prolonged exercise under hypoxic conditions. Information obtained via this study should provide valuable information with regard to optimisation of exercise training and athletic performance, and more importantly, provide pioneering insight on the metabolic and physiological responses to ketosis under hypoxic conditions.
- Being tested
- Ketone ester, Sodium bicarbonate, Placebo
- Keywords
- exercise, hypoxia, ketone
- Medical subject headings
- Motor Activity, Hypoxia, Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketone esterDietary supplement
75g ketone ester in the form of a drink [96% (R)-3-hydroxybutyl (R)-3-hydroxybutyrate, Oxfordshire, UK)] will be provided.
Sodium bicarbonateOther
Sodium bicarbonate - widely accessible food ingredient will be provided.
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Only carbohydrates will be provided Receives: Other: Placebo |
| Ketone ester | Experimental | Ketone ester with carbohydrates will be provided Receives: Dietary Supplement: Ketone ester |
| Ketone ester + bicarbonate | Experimental | Ketone ester with bicarbonate and carbohydrates will be provided Receives: Dietary Supplement: Ketone ester; Other: Sodium bicarbonate |
| Bicarbonate | Experimental | Bicarbonate and carbohydrates will be provided Receives: Other: Sodium bicarbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cycling performance - Simulated 15-min long time trial
Performance (average power output) during the 15 min long time trial on an ergometer
Measured: 5 hours - this is how long each experimental session is going to last. Subjects would be asked to do it 3 times as there are 3 different experimental conditions
Change in Cycling performance - Simulated Sprint
Time to exhaustion at 175% of the intensity of the second lactate threshold
Measured: 5 hours - this is how long each experimental session is going to last. Subjects would be asked to do it 3 times as there are 3 different experimental conditions
Change in Blood acid-base balance (pH and [HCO3-]) during cycling
Blood acid-base balance assement
Measured: 5 hours - this is how long each experimental session is going to last. Subjects would be asked to do it 3 times as there are 3 different experimental conditions
Secondary outcomes (6)
Change in Blood ketone concentrations during exercise
Blood ketone assesment
Measured: 5 hours - this is how long each experimental session is going to last. Subjects would be asked to do it 3 times as there are 3 different experimental conditions
Change in Blood glucose concentrations during exercise
Blood glucose assesment
Measured: 5 hours - this is how long each experimental session is going to last. Subjects would be asked to do it 3 times as there are 3 different experimental conditions
Change in Blood lactate concentrations during exercise
Blood lactate assesment
Measured: 5 hours - this is how long each experimental session is going to last. Subjects would be asked to do it 3 times as there are 3 different experimental conditions
Change in Respiratory parameters (VE, V̇O2 and V̇CO2) during exercise
Gas exchange measurement
Measured: 5 hours - this is how long each experimental session is going to last. Subjects would be asked to do it 3 times as there are 3 different experimental conditions
Change in arterial oxygen saturation during exercise
Pulse oxymetry measurement
Measured: 5 hours - this is how long each experimental session is going to last. Subjects would be asked to do it 3 times as there are 3 different experimental conditions
Change in muscle oxygenation during exercise
Near infrared spectroscopy measuremet
Measured: 5 hours - this is how long each experimental session is going to last. Subjects would be asked to do it 3 times as there are 3 different experimental conditions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start4 Nov 2020
- Primary completion5 Dec 2020
- Study completion15 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jozef Stefan Institute
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven
- Responsible party
- Principal investigator, Tadej Debevec, Jozef Stefan Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04579770
- Sponsor's protocol ID
- J5-9350
- Status last verified
- Feb 2021
- First submitted
- 24 Sep 2020
- Last updated
- 9 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral Ketone and Sodium Bicarbonate Administration on Physiological and Metabolic Parameters During Endurance Exercise in Hypoxia
- ClinicalTrials.gov ID
- NCT04579770
- Acronym / sponsor ID
- J5-9350
- Keywords
- exercise, hypoxia, ketone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Jozef Stefan InstituteUniversity, hospital or other
- Collaborators
- KU Leuven
- Study start
- 4 Nov 2020 (actual)
- Primary completion
- 5 Dec 2020 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 8 Oct 2020 (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 is investigating the effects of oral ketone and sodium bicarbonate administration on physiological and metabolic parameters during cycling endurance exercise in hypoxia. Ketone body supplementation is commonly used among elite endurance athletes that also compete in the hypoxia (at altitude). To-date effects of ketones have only been investigated in normoxia and the data in hypoxia is lacking. Hence, we want to investigate the effect of oral ketone ester intake with and without additional sodium bicarbonate (NaHCO3) ingestion on i) blood-acid base balance and ii) exercise performance during prolonged exercise under hypoxic conditions. Information obtained via this study should provide valuable information with regard to optimisation of exercise training and athletic performance, and more importantly, provide pioneering insight on the metabolic and physiological responses to ketosis under hypoxic conditions.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboOnly carbohydrates will be provided |
| Ketone ester | Experimental | Dietary Supplement: Ketone esterKetone ester with carbohydrates will be provided |
| Ketone ester + bicarbonate | Experimental | Dietary Supplement: Ketone ester, Other: Sodium bicarbonateKetone ester with bicarbonate and carbohydrates will be provided |
| Bicarbonate | Experimental | Other: Sodium bicarbonateBicarbonate and carbohydrates will be provided |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Males between 18 and 35 years old
- Recreational or competitive cyclist performing regularly cycling training sessions of at least 4 hours, with an average training volume of more than 6 hours per week
- Good health status confirmed by a medical screening
- VO2max higher than 55 ml.min-1.kg-1
- Body Mass Index (BMI) between 18 and 25
Key exclusion criteria (9 listed)
- 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
- Intake of analgesics, anti-inflammatory agents, or supplementary anti-oxidants, from 2 weeks prior to the start of the study.
- Blood donation within 3 months prior to the start of the study
- Smoking
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 ester75g ketone ester in the form of a drink [96% (R)-3-hydroxybutyl (R)-3-hydroxybutyrate, Oxfordshire, UK)] will be provided. | Dietary supplement | Ketone ester, Ketone ester + bicarbonate |
| Sodium bicarbonateSodium bicarbonate - widely accessible food ingredient will be provided. | Other | Bicarbonate, Ketone ester + bicarbonate |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Change in Cycling performance - Simulated 15-min long time trial
Time frame: 5 hours - this is how long each experimental session is going to last. Subjects would be asked to do it 3 times as there are 3 different experimental conditions
Performance (average power output) during the 15 min long time trial on an ergometer
Change in Cycling performance - Simulated Sprint
Time frame: 5 hours - this is how long each experimental session is going to last. Subjects would be asked to do it 3 times as there are 3 different experimental conditions
Time to exhaustion at 175% of the intensity of the second lactate threshold
Change in Blood acid-base balance (pH and [HCO3-]) during cycling
Time frame: 5 hours - this is how long each experimental session is going to last. Subjects would be asked to do it 3 times as there are 3 different experimental conditions
Blood acid-base balance assement
6 secondary outcomes
Change in Blood ketone concentrations during exercise
Time frame: 5 hours - this is how long each experimental session is going to last. Subjects would be asked to do it 3 times as there are 3 different experimental conditions
Change in Blood glucose concentrations during exercise
Time frame: 5 hours - this is how long each experimental session is going to last. Subjects would be asked to do it 3 times as there are 3 different experimental conditions
Change in Blood lactate concentrations during exercise
Time frame: 5 hours - this is how long each experimental session is going to last. Subjects would be asked to do it 3 times as there are 3 different experimental conditions
Change in Respiratory parameters (VE, V̇O2 and V̇CO2) during exercise
Time frame: 5 hours - this is how long each experimental session is going to last. Subjects would be asked to do it 3 times as there are 3 different experimental conditions
Change in arterial oxygen saturation during exercise
Time frame: 5 hours - this is how long each experimental session is going to last. Subjects would be asked to do it 3 times as there are 3 different experimental conditions
Change in muscle oxygenation during exercise
Time frame: 5 hours - this is how long each experimental session is going to last. Subjects would be asked to do it 3 times as there are 3 different experimental conditions
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 9 Feb 2021.
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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.
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 study testing Ketone ester and Sodium bicarbonate in people with Exercise and Hypoxia, run by Jozef Stefan Institute 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 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: finished, as of the sponsor's last update on 9 Feb 2021. 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 Cycling performance - Simulated 15-min long time trial (time frame: 5 hours - this is how long each experimental session is going to last. Subjects would be asked to do it 3 times as there are 3 different experimental conditions). 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 9 Feb 2021; AzTrials last refreshed its copy on 7 Nov 2026.