Ketone and Carbohydrate Supplementation in Endurance Cycling
Official title: Double-Blind Randomized Crossover Trial Examining the Effects of Ketone and Carbohydrate Supplementation on Molecular Biomarkers, Cognitive Function, and Physical Performance in Healthy Endurance Athletes
Run by University of Sao Paulo · NCT07792876 · Data updated 2026-11-12
This study tests whether adding ketones to a carb plan helps amateur endurance cyclists perform better and think more clearly during long, exhausting rides.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 20 Years to 50 Years |
| Sex | Men only |
| Enrollment | 12 (estimated) |
| Sponsor | University of Sao Paulo Academic / other |
| Locations | 1 site (Ribeirão Preto, São Paulo) |
| Status | Recruiting |
| Started | December 18, 2025 |
| Main results expected | January 2028 |
| Study ends | January 2029 |
| Registry record updated | August 28, 2026 |
| Trial ID | NCT07792876 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are amateur male cyclists with at least 2 years of cycling experience, 5+ hours of endurance training weekly, and a VO2max of 50 mL/kg/min or higher.
✕Probably not a fit
Individuals who do not respond to ketone supplementation or who have contraindications to high-fat or ketone-containing beverages may see no benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In this randomized, double-blind, crossover trial, amateur endurance cyclists will complete three 3-hour cycling sessions under different nutrition conditions: carbohydrate alone, carbohydrate plus ketone, and placebo. Researchers will measure cognitive performance with computer tests, physical output by distance covered, and blood biomarkers to understand metabolic responses. PBMCs will be cultured with and without inflammatory triggers to explore neuro-immune interactions. The goal is to see if ketones can support performance and brain function during prolonged exercise beyond energy supply alone.
Why it matters
Potential benefit: If ketones prove helpful, athletes may experience improved endurance performance and preserved cognitive function during long workouts.
How similar studies have gone: Previous trials on exogenous ketosis during prolonged cycling show mixed results, with some suggesting potential benefits but not yet definitive.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Amateur male cyclists; * At least 2 years of cycling experience; * At least 5 hours of endurance cycling training per week; * VO2max of at least 50 mL/kg/min. Exclusion Criteria: * Confirmed diagnosis of COVID-19 by PCR or rapid antigen test within the last 12 months; * Symptoms compatible with COVID-19 within the last six months; * Smokers; * Alcoholics; * Presence of neurological, immune, or muscular diseases; * Use of psychoactive medications in the last year; * Use of any acute medication prior three days each visit that possible could affect the experiment such as stool-altering medications and non-steroidal anti-inflammatory drugs; * Confirmed gastrointestinal infections, diseases, or disorders (e.g., coeliac disease, inflammatory bowel disease, irritable bowel syndrome, diverticular disease, gastroesophageal reflux disease); * Medical history of gastrointestinal surgery, or any other self-reported gastrointestinal issues; * Within the previous three months, if they had consumed substances that could affect gastrointestinal integrity or followed gastrointestinal-targeted dietary regimes; * Participants with any food allergy should be excluded of this study.
Where it's running
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School of Physical Education and Sport of Ribeirão Preto - University of São Paulo
Ribeirão Preto, São Paulo, Brazil Recruiting
Study contacts
- Principal investigator: Joao P Floriano — University of Sao Paulo
- Study coordinator: João P. Floriano, Bachelor of Nutrition
- Email: jp_floriano@usp.br
- Phone: +551699772-5355
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.