Capsimax for Exercise Performance

(Capsimax Trial)

Overseen By Adam M Gonzalez, PhD

Age: 18 - 65

Sex: Male

Trial Phase: Academic

Sponsor: Hofstra University

Must not be taking: All medications

Disqualifiers: Allergies, Medical conditions, Investigational drugs, others

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how Capsimax, a special form of capsaicin from chili peppers, might improve exercise performance. Researchers aim to determine if it enhances strength during exercises like squats, affects resting energy use, and improves muscle oxygen levels. The trial also examines how Capsimax influences reaction time around exercise. It is suitable for men experienced in resistance training who can perform barbell squats and are not taking medications or supplements that could interfere with the study. Participants will receive either Capsimax or a placebo (a non-active substitute) to compare results. As an unphased trial, this study offers a unique opportunity to contribute to understanding how Capsimax might enhance exercise performance.

Will I have to stop taking my current medications?

Yes, you will need to stop taking your current medications to participate in this trial, as participants must be free of any medications.

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

Research shows that Capsimax, a type of capsaicin from chili peppers, is under study for its safety and tolerability. Although specific safety data for Capsimax is not yet available, similar substances from chili peppers have been tested. These studies have found that healthy individuals generally tolerate them well.

Most people do not experience serious side effects, but some may feel a warm sensation or mild stomach upset, similar to eating spicy foods. As Capsimax is being tested for its effects on exercise performance, its safety remains under evaluation. Participants should consider this when deciding whether to join the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional exercise performance enhancers, Capsimax is derived from natural capsicum extract, which is a concentrated form of capsaicin found in chili peppers. This active ingredient is thought to boost metabolism and energy expenditure, potentially enhancing exercise performance without the stimulants typically found in other performance supplements. Researchers are excited about Capsimax because it offers a plant-based alternative that may support athletes and fitness enthusiasts in a more natural way, potentially reducing reliance on synthetic compounds.

What evidence suggests that Capsimax might be an effective treatment for exercise performance?

Research has shown that capsaicin, the main ingredient in Capsimax, can enhance exercise performance. Some studies found that capsaicin boosts strength and stamina during workouts. It might also increase the number of calories the body burns while at rest. Capsaicin is believed to improve muscle oxygenation, enhancing performance during exercise. This trial will evaluate Capsimax, which contains capsaicin, to determine its effectiveness in enhancing workout performance and energy use. ^{1 2 4 6 7}

Who Is on the Research Team?

Adam M Gonzalez, PhD

Principal Investigator

Hofstra University

Are You a Good Fit for This Trial?

This trial is for healthy volunteers interested in the effects of a chili pepper extract, Capsimax, on exercise performance. Participants should be willing to undergo tests for muscle strength, energy expenditure, and reaction time during resistance exercises.

Inclusion Criteria

Subjects proficient in the barbell back squat exercise

Subjects willing to provide written consent

I am not taking any medications.

Exclusion Criteria

Subjects with hypersensitivity or history of allergy to the study product

Subjects with any other medical condition that might adversely impact the safety of the study participants or confound the study results

Subjects who had been treated with any investigational drug or investigational device within a period of 3 months prior to study entry

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either Capsimax or placebo and undergo resistance exercise performance tests, including isometric strength tests and barbell back squat exercises.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of reaction time, energy expenditure, and subjective feelings of pain and exertion.

1 day

What Are the Treatments Tested in This Trial?

Interventions

• Capsimax

Trial Overview The study is testing Capsimax's impact on resistance exercise outcomes like power and endurance. It also looks at how it affects resting energy use, muscle oxygen levels, nitric oxide release during workouts, and reaction times.

How Is the Trial Designed?

Group I: Capsimax Experimental Treatment 1 Intervention

Capsules containing either 100 mg Capsimax (OmniActive Health Technologies)

Group II: Placebo Placebo Group 1 Intervention

Microcrystalline cellulose

Who Is Running the Clinical Trial?

Hofstra University

Lead Sponsor

Trials

6

Recruited

320+

OmniActive Health Technologies

Industry Sponsor

Trials

7

Recruited

180+

Published Research Related to This Trial

In a study of 35,110 exercise interventions for pediatric cancer patients and survivors, serious adverse events (AEs) were rare, with only six Grade 2-3 AEs reported, resulting in an incidence of 17 per 100,000 interventions, indicating that supervised exercise programs are generally safe.

While Grade 1 AEs, such as muscle soreness and circulatory problems, were more common (2,800 per 100,000 interventions), these were typically mild and likely not directly caused by the exercise, suggesting that exercise can be safely integrated into cancer care for children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events During Supervised Exercise Interventions in Pediatric Oncology-A Nationwide Survey. Gauß, G., Beller, R., Boos, J., et al.[2021]

The ADVANCE study aims to evaluate how adverse events (AEs) are reported in exercise oncology trials, which is crucial for assessing the safety of exercise interventions for cancer patients.

By reviewing published trials and using a standardized checklist for reporting AEs, the study seeks to identify gaps in current practices and inform future research on improving the consistency and transparency of AE reporting in this field.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events Reporting of Clinical Trials in Exercise Oncology Research (ADVANCE): Protocol for a Scoping Review. Luo, H., Schumacher, O., Galvão, DA., et al.[2022]

Researchers in resistance training studies often lack clear guidance and motivation for thorough adverse event (AE) reporting, which can lead to inconsistent practices.

There is a need for exercise-specific guidelines for AE reporting, as current standards are perceived as not applicable to exercise trials, highlighting the importance of tailored strategies to improve reporting consistency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Researchers' perspectives on adverse event reporting in resistance training trials: a qualitative study. El-Kotob, R., Pagcanlungan, JR., Craven, BC., et al.[2022]

This extensive 18-year study involving 50,142 exercise tests in a clinical Chinese population found a very low rate of adverse events, at just 0.6 events per 10,000 tests, indicating that exercise testing is generally safe.

The study highlights that the majority of patients undergoing these tests had existing health conditions, yet the low incidence of serious adverse events suggests improvements in clinical practices over time have enhanced safety during exercise testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Exercise Testing in the Clinical Chinese Population. Dun, Y., Olson, TP., Ripley-Gonzalez, JW., et al.[2021]

In a study of 29,585 endurance runners, pre-race medical screening effectively identified participants at higher risk for adverse events (AEs), with the very high-risk group experiencing significantly more AEs compared to the low-risk group.

The findings suggest that risk stratification can help predict who may face challenges during a race, although further research is needed to determine how screening can reduce these risks in larger populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-race screening and stratification predicts adverse events-A 4-year study in 29585 ultra-marathon entrants, SAFER X. Sewry, N., Schwellnus, M., Borjesson, M., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06612658?term=AREA%5BBasicSearch%5D(AREA%5BInterventionSearch%5D(capsicum))&rank=9

Acute Effect of Capsimax on Resistance Exercise ... The purpose of this study is to investigate the effect of Capsimax on resistance exercise performance, reaction time, and resting energy expenditure around ...

2. withpower.com withpower.com/trial/phase-none-volunteer-9-2024-12076

Capsimax for Exercise Performance · Info for Participants Trial Overview The study is testing Capsimax's impact on resistance exercise outcomes like power and endurance. It also looks at how it affects resting energy ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8778706/

Capsaicin and Its Effect on Exercise Performance, Fatigue and ... Thus there have been some reports of performance improvements induced by the consumption of a single 12 mg dose of purified CAP during a 1500-m ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2214750018300830

Capsaicinoids improve consequences of physical activity The purpose of this study was to investigate the effects of capsaicinoids (CAPs) on lipid metabolism, inflammation, antioxidant status and the changes in ...

5. trial.medpath.com trial.medpath.com/clinical-trial/8ff436751ca46813/nct06612658-capsimax-exercise-performance-muscle-oxygenation

Acute Effect of Capsimax on Resistance Exercise ... - MedPath Primary Objective • To examine the effects of Capsimax on physical performance metrics including peak power and rate of force development during an isometric ...

6. ctv.veeva.com ctv.veeva.com/study/acute-effect-of-capsimax-on-resistance-exercise-performance-muscle-oxygenation-nitric-oxide-releas

Acute Effect of Capsimax on Resistance Exercise ... The purpose of this study is to investigate the effect of Capsimax on resistance exercise performance, reaction time, and resting energy ...

7. isrctn.com isrctn.com/pdf/10975080

Tolerability and safety of capsaicinoids from capsicum ... This study will test how safe and tolerable Capsimax™ is when taken by healthy women compared with a placebo. Who can participate? Healthy women ...