Ketone Supplements for Cycling Performance

Overseen By Cole Connell

Age: 18 - 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Oklahoma

Disqualifiers: Cardiovascular, Respiratory, Gastrointestinal, Metabolic, others

Compensation: Varies

Number of Visits: 4

Duration: 3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if adding ketone supplements to carbohydrates helps trained cyclists bike longer before fatigue sets in, compared to using carbohydrates alone. Researchers also seek to find out if this combination lowers blood lactate levels, a marker of muscle fatigue. Participants will be healthy cyclists who train at least six hours a week and are already involved with cycling groups or events in Oklahoma. During the trial, cyclists will ride on a stationary bike, consume different supplements, and undergo blood tests. This study suits dedicated cyclists interested in exploring new ways to boost performance. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking performance-enhancing strategies.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial organizers or your doctor.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that ketone supplements, when taken with carbohydrates, have been tested in various studies to assess their impact on exercise performance. These studies generally find that ketone supplements are safe for use, with most people experiencing no serious issues. Some research even suggests that these supplements might enhance cycling performance when combined with substances like bicarbonate.

However, not all studies agree on the benefits for sports performance. While they appear safe, their actual effect on improving exercise outcomes, such as delaying fatigue, remains under investigation. Therefore, although ketone supplements are generally considered safe, their ability to enhance performance may vary. Always consult a doctor before starting any new supplement. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for boosting cycling performance focus on enhancing carbohydrate intake to increase energy. However, ketone supplementation with carbohydrates offers a fresh approach by providing an alternative energy source through ketones. Researchers are excited about this treatment because ketones can supply energy efficiently without the spikes and crashes often associated with high-carb diets. This could mean more sustained energy and improved performance for cyclists, making it a compelling addition to current strategies.

What evidence suggests that ketone supplements with carbohydrates might be effective for cycling performance?

This trial will compare ketone supplementation with carbohydrates to a carbohydrate supplement alone. Research has shown that combining ketone supplements with carbohydrates might help cyclists by conserving stored energy and reducing muscle breakdown. However, a review of studies found no clear proof that ketone supplements improve oxygen use during exercise in endurance sports like running. Another study suggested that while ketone supplements might aid recovery and fat burning, strong evidence does not support their enhancement of sports performance. So far, evidence that ketone supplements significantly improve cycling endurance or reduce fatigue remains limited. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for healthy, trained cyclists aged 18-55 who can perform a maximal cycling exercise test. They must be willing to consume supplements and undergo finger pricks for blood measurements. People with health conditions that could affect performance or safety during the trial cannot participate.

Inclusion Criteria

Greater than or equal to six hours of cycling training per week

I am a highly trained athlete.

I am between 18 and 55 years old.

Exclusion Criteria

Pregnancy

I have a lung or breathing condition.

I have a gastrointestinal condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Familiarization

Participants complete a maximal graded exercise test and fill out questionnaires

1 hour

1 visit (in-person)

Treatment

Participants perform cycling tests and consume supplements; blood samples are taken

3 weeks

3 visits (in-person), each separated by at least 7 days

Follow-up

Participants are monitored for performance and metabolic responses

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ketone Supplements with Carbohydrates

Trial Overview The study tests if taking ketone supplements along with carbohydrates improves cycling performance above lactate threshold better than carbs alone. It measures time to fatigue and blood lactate levels in participants performing intense cycling exercises.

How Is the Trial Designed?

Group I: Ketone supplementation with carbohydrates Experimental Treatment 2 Interventions

Group II: Carbohydrate supplement only Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11569574/

The Effects of Ketogenic Diets and Ketone Supplements on ... This review of 12 studies showed no advantages or disadvantages of ketogenic diets and ketone supplements on the aerobic performance of endurance runners.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07224282

The Effects of Ketone Supplements With Carbohydrates on ... The study aims to investigate the performance effects of a ketone supplement (R-1,3-Butanediol) with carbohydrate supplementation on cycling ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2161831322002654

Utility of Ketone Supplementation to Enhance Physical ... This systematic review aimed to aggregate data from the current literature to examine the impact of consuming ketone supplements on enhancing physical ...

4. mdpi.com mdpi.com/2673-9488/4/4/29

The Role of Exogenous Ketones in Road Cycling Results: Ketone body supplementation can theoretically spare glycogen, reduce muscle protein breakdown, enhance fat oxidation, and improve recovery by ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8243601/

Perspective: Ketone Supplementation in Sports—Does It Work? Evidence to date does not support a benefit of acute ketone supplementation on sports performance, cognition, or muscle recovery.

6. usada.org usada.org/spirit-of-sport/ketones-frequently-asked-questions/

Athletes and Ketones: Frequently Asked Questions However, there is little to no evidence that consuming metabolic ketones without changing your diet or exercise levels will have any effect on weight or ...

7. journals.humankinetics.com journals.humankinetics.com/view/journals/ijsnem/34/1/article-p1.xml

Effects of Ketone Monoester and Bicarbonate Co-Ingestion ... The main finding of the present study was that acute supplementation of KE + NaHCO3 co-ingestion, improved cycling performance during the first ...