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Endurance Trial: Ketone and Carbohydrate Supplementation

RecruitingNAAges 20 Years - 50 YearsMaleUniversity of Sao Paulo
NCT07792876 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This randomized, double-blind, crossover study investigates the effects of exogenous ketone supplementation on physical and cognitive performance in amateur endurance athletes during exhaustive exercise. Participants will complete three 3-hour cycling sessions under different nutritional conditions: carbohydrate alone (CHO), carbohydrate plus ketone (CHO-KET), and placebo (PLA). The study will assess cognitive function through validated computerized tests, physical performance via distance covered, and metabolic responses through blood biomarkers. Additionally, peripheral blood mononuclear cells (PBMCs) will be collected and cultured with LPS or not. Other PBMCs co-cultured with neuronal cells (SH-SY5Y) to investigate neuro-immune interactions. The primary hypothesis is that ketone supplementation will preserve cognitive function and enhance physical performance during prolonged exhausti

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📋 Eligibility rules (as published)
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.
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What it tests

  • Carbohydrate beverage
  • (R)-1,3-butanediol
  • Pre-exercise non-caloric placebo
  • During-exercise non-caloric placebo
  • Standardized evening meal
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Where

1 site
School of Physical Education and Sport of Ribeirão Preto - University of São Paulo
Ribeirão Preto, Brazil
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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