The Effects of Ketone Supplements With Carbohydrates on Cycling Performance Above Lactate Threshold
The Effects of R-1,3-Butanediol With Carbohydrate Supplementation on Cycling Performance Above Lactate Threshold
1 other identifier
interventional
15
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1
Started Nov 2025
Shorter than P25 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2025
CompletedFirst Posted
Study publicly available on registry
November 4, 2025
CompletedStudy Start
First participant enrolled
November 17, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 9, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 3, 2026
CompletedNovember 4, 2025
November 1, 2025
4 months
October 28, 2025
November 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to fatigue
Through study completion, an average of 2 weeks.
Secondary Outcomes (3)
Blood lactate
Through study completion, an average of 2 weeks.
Blood Glucose
Through study completion, an average of 2 weeks.
Beta-hydroxybutyrate levels
Through study completion, an average of 2 weeks.
Study Arms (2)
Ketone supplementation with carbohydrates
EXPERIMENTALCarbohydrate supplement only
PLACEBO COMPARATORInterventions
30-gram carbohydrate beverage with 5 grams of R-1,3-Butanediol every 30 minutes of experimental visit
30-gram carbohydrate beverage with bitter flavoring
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Cardiovascular disease
- Respiratory disease
- Gastrointestinal disease
- Metabolic disease
- Kidney disease
- Neurological disease
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Oklahoma
Norman, Oklahoma, 73019, United States
Related Publications (5)
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.
PMID: 28116349BACKGROUNDDearlove 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.
PMID: 32868580BACKGROUNDLeckey 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.
PMID: 29109686BACKGROUNDShaw 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.
PMID: 30632425BACKGROUNDCox 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.
PMID: 27475046BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2025
First Posted
November 4, 2025
Study Start
November 17, 2025
Primary Completion
March 9, 2026
Study Completion
May 3, 2026
Last Updated
November 4, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share