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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

Capsimax is a novel, proprietary encapsulated form of capsaicin, a natural and bioactive phytochemical found in chili pepper and other spicy food. The purpose of this study is to investigate the effect of Capsimax on resistance exercise performance, reaction time, and resting energy expenditure around exercise. This investigation will also measure muscle oxygenation and intramuscular nitric oxide in real time during resistance exercise using a non-invasive wearable technology. Primary Objective • To examine the effects of Capsimax on physical performance metrics including peak power and rate of force development during an isometric strength test and performance during the barbell back squat exercise protocol (e.g., repetitions performed, total volume, peak power, average power). Secondary Objectives * To examine the effects of Capsimax on resting energy expenditure around exercise. * To examine the effects of Capsimax on nitric oxide bioavailability and skeletal muscle oxygenation during exercise. Exploratory Objective • To examine the effects of Capsimax on reaction time around exercise

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 Capsimax generally safe for human use?

There is no specific safety data available for Capsimax in the provided research articles. However, general exercise interventions, including those in clinical settings, have shown low rates of adverse events, suggesting that exercise-related treatments are generally safe. ^{1 2 3 4 5}

How does the treatment Capsimax differ from other treatments for exercise performance?

Capsimax is unique because it contains capsaicinoids, which are compounds found in chili peppers that may enhance metabolism and energy expenditure, potentially improving exercise performance. Unlike other treatments, Capsimax is a natural supplement that leverages the thermogenic (heat-producing) properties of capsaicinoids to support physical activity. ^{6 7 8 9 10}

Research Team

Adam M Gonzalez, PhD

Principal Investigator

Hofstra University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Researchers' perspectives on adverse event reporting in resistance training trials: a qualitative study. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Safety of Exercise Testing in the Clinical Chinese Population. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Adverse Events Reporting of Clinical Trials in Exercise Oncology Research (ADVANCE): Protocol for a Scoping Review. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Adverse Events During Supervised Exercise Interventions in Pediatric Oncology-A Nationwide Survey. [2021]

5. Denmark pubmed.ncbi.nlm.nih.gov

Pre-race screening and stratification predicts adverse events-A 4-year study in 29585 ultra-marathon entrants, SAFER X. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Temporal response of post-activation performance enhancement induced by a plyometric conditioning activity. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Effects of heat removal through the hand on metabolism and performance during cycling exercise in the heat. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Faster V̇O2 kinetics after priming exercises of different duration but same fatigue. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Influence of priming exercise on pulmonary O2 uptake kinetics during transitions to high-intensity exercise from an elevated baseline. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

The effects of postactivation potentiation on sprint and jump performance of male academy soccer players. [2016]