Clinical trial Recruiting at 1 site Interventional Ages 20 to 50 Men only

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 typeInterventional
Ages20 Years to 50 Years
SexMen only
Enrollment12 (estimated)
SponsorUniversity of Sao Paulo
Academic / other
Locations1 site (Ribeirão Preto, São Paulo)
StatusRecruiting
StartedDecember 18, 2025
Main results expectedJanuary 2028
Study endsJanuary 2029
Registry record updatedAugust 28, 2026
Trial IDNCT07792876 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

  • 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

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.