NCT07792876 Endurance Trial: Ketone and Carbohydrate Supplementation
| NCT ID | NCT07792876 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Sao Paulo |
| Condition | Athletic Performance |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2025-12-18 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 12 participants in total. It began in 2025-12-18 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 exhaustive exercise compared to carbohydrate supplementation alone, potentially through anti-inflammatory mechanisms and alternative energy substrate provision.
Eligibility 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.
Contact & Investigator
Joao P Floriano
PRINCIPAL INVESTIGATOR
University of Sao Paulo
Frequently Asked Questions
Who can join the NCT07792876 clinical trial?
This trial is open to male participants only, aged 20 Years or older, up to 50 Years, studying Athletic Performance. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07792876 currently recruiting?
Yes, NCT07792876 is actively recruiting participants. Contact the research team at jp_floriano@usp.br for enrollment information.
Where is the NCT07792876 trial being conducted?
This trial is being conducted at Ribeirão Preto, Brazil.
Who is sponsoring the NCT07792876 clinical trial?
NCT07792876 is sponsored by University of Sao Paulo. The principal investigator is Joao P Floriano at University of Sao Paulo. The trial plans to enroll 12 participants.