Exogenous KetosisEarly Phase 1NCT07224282
The Effects of Ketone Supplements With Carbohydrates on Cycling Performance Above Lactate Threshold
A Early Phase 1 study testing Ketone supplementation and Carbohydrate in people with Exogenous Ketosis, run by University of Oklahoma at 1 site in United States.
Trial summary
The goal of this clinical trial is to determine whether a ketone supplement with carbohydrates extends time to fatigue during cycling compared with a carbohydrate-only supplement in healthy, trained cyclists aged 18-55. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Exogenous Ketosis
- What is being tested?
- Ketone supplementation and Carbohydrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2025to 3 May 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Highly trained males and females
- Ages 18-55
- Greater than or equal to six hours of cycling training per week
- Participants from the University of Oklahoma, Oklahoma cycling teams, and local cycling races in Oklahoma.
Who cannot join
- Cardiovascular disease
- Respiratory disease
- Gastrointestinal disease
- Metabolic disease
- Kidney disease
- Neurological disease
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Oklahoma
Norman, Oklahoma, 73019
Rebecca Larson, Ph.D, 405-325-5211, rdlarson@ou.eduu
About this study
Official title: The Effects of R-1,3-Butanediol With Carbohydrate Supplementation on Cycling Performance Above Lactate Threshold
The goal of this clinical trial is to determine whether a ketone supplement with carbohydrates extends time to fatigue during cycling compared with a carbohydrate-only supplement in healthy, trained cyclists aged 18-55. The main questions it aims to answer are:
Is the time to fatigue increased with ketone supplementation and carbohydrates compared to carbohydrates alone? Will ketone supplementation with carbohydrates produce lower blood lactate concentrations compared to carbohydrates alone?
Read more
Participants will:
- Perform a staged maximal cycling exercise test on a stationary bicycle.
- Finger prick to obtain a drop of blood for lactate measurements.
- Wear a mask connected to a metabolic cart to measure breath contents.
- Perform a cycling exercise test to fatigue for at least one hour.
- Consume either a ketone supplement with carbohydrates or a carbohydrate supplement during the exercise at least 4 times.
- Finger prick to obtain a drop of blood to measure blood lactate, ketones, and glucose.
Read the detailed description
The significance of this study is to address gaps in the literature by investigating the combined effects of R-1,3-Butanediol and carbohydrate supplementation on cycling performance during steady-state exercise above the lactate threshold. Participants include:
- Trained cyclists ages 18-55
- ≥ 6 hours of cycle training per week.
- Above average VO2max for their age range per ACSM guidelines.
- The sample is drawn from the University of Oklahoma, local cycling events in Oklahoma, and local bicycle shops.
There will be a total of three visits, lasting approximately one hour and separated by at least 7 days. The protocol begins with a familiarization visit, during which participants complete a maximal graded exercise test. They are instructed to be at least 4 hours postabsorptive and not complete strenuous exercise within 24 hours of the initial visit, and each participant signs an informed consent form, fills out a POMS questionnaire, and exercise history questionnaire (PAR-Q). Participants' height and weight were recorded, and their bicycles will be connected to the cycling trainer or will use the Zwift One stationary bicycle. To determine VO2 max and lactate threshold, a continuous incremental cycling test will be performed. The test begins at 1 watt per kilogram of body weight and increases 0.5 watts per kilogram of body weight every 3 minutes until two of the following were reached: volitional fatigue, inability to maintain cadence within 10 rpm of their preferred cadence, maximal heart rate within 10 bpm of age-predicted max heart rate, or respiratory exchange ratio greater than 1.10 The intent is to provide insights into metabolic and performance responses beyond traditional exercise intensities. The findings could inform endurance athletes and coaches on nutritional strategies for sustaining performance during high-intensity efforts.The study aims to investigate the performance effects of a ketone supplement (R-1,3-Butanediol) with carbohydrate supplementation on cycling performance above the lactate threshold. It aims to determine whether time to fatigue will be affected and if blood lactate concentrations will decrease due to ketone supplementation. Hypotheses include:
Time to fatigue is increased with ketone supplementation and carbohydrates compared to carbohydrates alone.
Ketone supplementation with carbohydrates will produce lower blood lactate concentrations compared to carbohydrates alone.
- Conditions
- Exogenous Ketosis
- Being tested
- Ketone supplementation, Carbohydrate
- Keywords
- Exogenous ketones, Time to fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketone supplementationDietary supplement
30-gram carbohydrate beverage with 5 grams of R-1,3-Butanediol every 30 minutes of experimental visit
CarbohydrateDietary supplement
Also called Dextrose
30-gram carbohydrate beverage with bitter flavoring
| Study group | Role | What they receive |
|---|---|---|
| Ketone supplementation with carbohydrates | Experimental | Not described Receives: Dietary Supplement: Ketone supplementation; Dietary Supplement: Carbohydrate |
| Carbohydrate supplement only | Placebo comparator | Not described Receives: Dietary Supplement: Carbohydrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to fatigue
Measured: Through study completion, an average of 2 weeks.
Secondary outcomes (3)
Blood lactate
Measured: Through study completion, an average of 2 weeks.
Blood Glucose
Measured: Through study completion, an average of 2 weeks.
Beta-hydroxybutyrate levels
Using a finger prick to obtain a drop of blood to measure beta-hydroxybutyrate levels in the blood.
Measured: Through study completion, an average of 2 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2025
- Study start17 Nov 2025 (estimated)
- Primary completion9 Mar 2026 (estimated)
- Study completion3 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Exogenous KetosisStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07224282
- Sponsor's protocol ID
- 18836
- Status last verified
- Nov 2025
- First submitted
- 28 Oct 2025
- Last updated
- 4 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Beltz NM, Gibson AL, Janot JM, Kravitz L, Mermier CM, Dalleck LC. Graded Exercise Testing Protocols for the Determination of VO2max: Historical Perspectives, Progress, and Future Considerations. J Sports Med (Hindawi Publ Corp). 2016;2016:3968393. doi: 10.1155/2016/3968393. Epub 2016 Dec 25.
PubMed 28116349Dearlove DJ, Harrison OK, Hodson L, Jefferson A, Clarke K, Cox PJ. The Effect of Blood Ketone Concentration and Exercise Intensity on Exogenous Ketone Oxidation Rates in Athletes. Med Sci Sports Exerc. 2021 Mar 1;53(3):505-516. doi: 10.1249/MSS.0000000000002502.
PubMed 32868580Leckey JJ, Ross ML, Quod M, Hawley JA, Burke LM. Ketone Diester Ingestion Impairs Time-Trial Performance in Professional Cyclists. Front Physiol. 2017 Oct 23;8:806. doi: 10.3389/fphys.2017.00806. eCollection 2017.
PubMed 29109686Shaw DM, Merien F, Braakhuis A, Plews D, Laursen P, Dulson DK. The Effect of 1,3-Butanediol on Cycling Time-Trial Performance. Int J Sport Nutr Exerc Metab. 2019 Sep 1;29(5):466-473. doi: 10.1123/ijsnem.2018-0284.
PubMed 30632425Cox PJ, Kirk T, Ashmore T, Willerton K, Evans R, Smith A, Murray AJ, Stubbs B, West J, McLure SW, King MT, Dodd MS, Holloway C, Neubauer S, Drawer S, Veech RL, Griffin JL, Clarke K. Nutritional Ketosis Alters Fuel Preference and Thereby Endurance Performance in Athletes. Cell Metab. 2016 Aug 9;24(2):256-68. doi: 10.1016/j.cmet.2016.07.010. Epub 2016 Jul 27.
PubMed 27475046
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of R-1,3-Butanediol With Carbohydrate Supplementation on Cycling Performance Above Lactate Threshold
- ClinicalTrials.gov ID
- NCT07224282
- Acronym / sponsor ID
- 18836
- Conditions
- Exogenous Ketosis
- Keywords
- Exogenous ketones, Time to fatigue
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 17 Nov 2025 (estimated)
- Primary completion
- 9 Mar 2026 (estimated)
- Study completion
- 3 May 2026 (estimated)
- First posted
- 4 Nov 2025 (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.
The goal of this clinical trial is to determine whether a ketone supplement with carbohydrates extends time to fatigue during cycling compared with a carbohydrate-only supplement in healthy, trained cyclists aged 18-55. The main questions it aims to answer are:
Is the time to fatigue increased with ketone supplementation and carbohydrates compared to carbohydrates alone? Will ketone supplementation with carbohydrates produce lower blood lactate concentrations compared to carbohydrates alone?
Participants will:
- Perform a staged maximal cycling exercise test on a stationary bicycle.
- Finger prick to obtain a drop of blood for lactate measurements.
- Wear a mask connected to a metabolic cart to measure breath contents.
- Perform a cycling exercise test to fatigue for at least one hour.
- Consume either a ketone supplement with carbohydrates or a carbohydrate supplement during the exercise at least 4 times.
- Finger prick to obtain a drop of blood to measure blood lactate, ketones, and glucose.
Detailed description
The significance of this study is to address gaps in the literature by investigating the combined effects of R-1,3-Butanediol and carbohydrate supplementation on cycling performance during steady-state exercise above the lactate threshold. Participants include:
- Trained cyclists ages 18-55
- ≥ 6 hours of cycle training per week.
- Above average VO2max for their age range per ACSM guidelines.
- The sample is drawn from the University of Oklahoma, local cycling events in Oklahoma, and local bicycle shops.
There will be a total of three visits, lasting approximately one hour and separated by at least 7 days. The protocol begins with a familiarization visit, during which participants complete a maximal graded exercise test. They are instructed to be at least 4 hours postabsorptive and not complete strenuous exercise within 24 hours of the initial visit, and each participant signs an informed consent form, fills out a POMS questionnaire, and exercise history questionnaire (PAR-Q). Participants' height and weight were recorded, and their bicycles will be connected to the cycling trainer or will use the Zwift One stationary bicycle. To determine VO2 max and lactate threshold, a continuous incremental cycling test will be performed. The test begins at 1 watt per kilogram of body weight and increases 0.5 watts per kilogram of body weight every 3 minutes until two of the following were reached: volitional fatigue, inability to maintain cadence within 10 rpm of their preferred cadence, maximal heart rate within 10 bpm of age-predicted max heart rate, or respiratory exchange ratio greater than 1.10 The intent is to provide insights into metabolic and performance responses beyond traditional exercise intensities. The findings could inform endurance athletes and coaches on nutritional strategies for sustaining performance during high-intensity efforts.The study aims to investigate the performance effects of a ketone supplement (R-1,3-Butanediol) with carbohydrate supplementation on cycling performance above the lactate threshold. It aims to determine whether time to fatigue will be affected and if blood lactate concentrations will decrease due to ketone supplementation. Hypotheses include:
Time to fatigue is increased with ketone supplementation and carbohydrates compared to carbohydrates alone.
Ketone supplementation with carbohydrates will produce lower blood lactate concentrations compared to carbohydrates alone.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketone supplementation with carbohydrates | Experimental | Dietary Supplement: Ketone supplementation, Dietary Supplement: Carbohydrate |
| Carbohydrate supplement only | Placebo comparator | Dietary Supplement: Carbohydrate |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Highly trained males and females
- Ages 18-55
- Greater than or equal to six hours of cycling training per week
- Participants from the University of Oklahoma, Oklahoma cycling teams, and local cycling races in Oklahoma.
Key exclusion criteria (7 listed)
- Cardiovascular disease
- Respiratory disease
- Gastrointestinal disease
- Metabolic disease
- Kidney disease
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 supplementation30-gram carbohydrate beverage with 5 grams of R-1,3-Butanediol every 30 minutes of experimental visit | Dietary supplement | Ketone supplementation with carbohydrates |
| CarbohydrateAlso: Dextrose30-gram carbohydrate beverage with bitter flavoring | Dietary supplement | Carbohydrate supplement only, Ketone supplementation with carbohydrates |
Primary outcome
Time to fatigue
Time frame: Through study completion, an average of 2 weeks.
3 secondary outcomes
Blood lactate
Time frame: Through study completion, an average of 2 weeks.
Blood Glucose
Time frame: Through study completion, an average of 2 weeks.
Beta-hydroxybutyrate levels
Time frame: Through study completion, an average of 2 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2025.
- Background: PubMed 28116349Beltz NM, Gibson AL, Janot JM, Kravitz L, Mermier CM, Dalleck LC. Graded Exercise Testing Protocols for the Determination of VO2max: Historical Perspectives, Progress, and Future Considerations. J Sports Med (Hindawi Publ Corp). 2016;2016:3968393. doi: 10.1155/2016/3968393. Epub 2016 Dec 25.
- Background: PubMed 32868580Dearlove DJ, Harrison OK, Hodson L, Jefferson A, Clarke K, Cox PJ. The Effect of Blood Ketone Concentration and Exercise Intensity on Exogenous Ketone Oxidation Rates in Athletes. Med Sci Sports Exerc. 2021 Mar 1;53(3):505-516. doi: 10.1249/MSS.0000000000002502.
- Background: PubMed 29109686Leckey JJ, Ross ML, Quod M, Hawley JA, Burke LM. Ketone Diester Ingestion Impairs Time-Trial Performance in Professional Cyclists. Front Physiol. 2017 Oct 23;8:806. doi: 10.3389/fphys.2017.00806. eCollection 2017.
- Background: PubMed 30632425Shaw DM, Merien F, Braakhuis A, Plews D, Laursen P, Dulson DK. The Effect of 1,3-Butanediol on Cycling Time-Trial Performance. Int J Sport Nutr Exerc Metab. 2019 Sep 1;29(5):466-473. doi: 10.1123/ijsnem.2018-0284.
- Background: PubMed 27475046Cox PJ, Kirk T, Ashmore T, Willerton K, Evans R, Smith A, Murray AJ, Stubbs B, West J, McLure SW, King MT, Dodd MS, Holloway C, Neubauer S, Drawer S, Veech RL, Griffin JL, Clarke K. Nutritional Ketosis Alters Fuel Preference and Thereby Endurance Performance in Athletes. Cell Metab. 2016 Aug 9;24(2):256-68. doi: 10.1016/j.cmet.2016.07.010. Epub 2016 Jul 27.
- Individual participant dataSharing planned: No
Related trials for Exogenous Ketosis
Enrolling by invitationPhase 2
Chronic Exogenous Ketosis in HFpEF
Heart Failure With Preserved Ejection Fraction (HFPEF), Heart Failure With Normal Ejection Fraction
RecruitingPhase 2
Exogenous Ketone Supplementation in ICU Delirium
ICU Delirium, Critical Illness
Recruiting
Recovery With Exogenous Ketones and Antipsychotics
First Episode Psychosis
Recruiting
Symptoms of Polycystic Ovarian Syndrome Ameliorated by Keto-Adaptation Pilot
PCOS (Polycystic Ovary Syndrome)
RecruitingPhase 2
Exogenous KETOne Supplements in Patients Hospitalized for Acute Heart Failure
Acute Heart Failure (AHF)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Ketone supplementation and Carbohydrate in people with Exogenous Ketosis, run by University of Oklahoma at 1 site in United States.
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 4 inclusion and 7 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: opening soon, as of the sponsor's last update on 4 Nov 2025. 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 United States. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rebecca Larson, Ph.D. (405-325-5211, rdlarson@ou.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to fatigue (time frame: Through study completion, an average of 2 weeks.). 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 NCT07224282, which also lists 5 linked publications.
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 4 Nov 2025.