Clinical trial NCT06612658: Acute Effect of Capsimax on Resistance Exercise Performance, Muscle Oxygenation, Nitric Oxide Release, Resting Energy Expenditure and Reaction Time
Official title: A Prospective, Randomized Double-Blind, Placebo-Controlled, Cross-Over Study to Evaluate Acute Effect of Capsimax on Resistance Exercise Performance, Muscle Oxygenation, Nitric Oxide Release, Resting Energy Expenditure and Reaction Time
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: None Volunteer
Keywords: capsaicin
capsimax
Lead sponsor: Hofstra University
Sponsor class: OTHER
Collaborators: name: OmniActive Health Technologies
First posted: 2024-09-25
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, double-blind, placebo-controlled, cross-over study
Primary purpose: OTHER

Brief summary: 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

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

1. Male subjects aged between 18-35 years (both limits inclusive).
2. Subjects must have a BMI of 18.5 to 29.9 kg/m2 (both limits inclusive)
3. Subjects must have greater than one year of resistance training experience at a frequency of 2 days per week.
4. Subjects must be proficient in the barbell back squat exercise.
5. Subjects must be free of any physical limitations or chronic illness that may affect performance.
6. Subjects must be free of any medications.
7. Subjects who agree to refrain from consuming alcohol 24 hours prior to the visit days.
8. Subjects who agreed to refrain from consuming caffeine and caffeine-containing products 12 hour prior to visit days
9. Subject willing to provide written consent.

Exclusion Criteria:

1. Subjects who have hypersensitivity or history of allergy to the study product.
2. Subjects with inability to swallow soft gel capsules.
3. Subjects with any other medical condition that might adversely impact the safety of the study participants or confound the study results.
4. Subjects who require medications.
5. Subjects who regularly use a dietary supplement containing Capsimax or other ingredients that would impact study endpoints.
6. Subjects who had been treated with any investigational drug or investigational device within a period of 3 months prior to study entry

Primary outcomes:
measure: Resistance exercise performance
timeFrame: 1 day
measure: Isometric strength test
timeFrame: 1 day
Secondary outcomes:
measure: Energy expenditure
timeFrame: 1 day
measure: Nitric oxide release and skeletal muscle oxygenation
timeFrame: 1 day
measure: Subjective feelings of pain and rating of perceived exertion
timeFrame: 1 day
Other outcomes:
measure: Reaction time
timeFrame: 1 day
Locations:
city: Hempstead
country: United States
facility: Hofstra University
state: New York
Study officials:
affiliation: Hofstra University
name: Adam M Gonzalez, PhD
role: PRINCIPAL_INVESTIGATOR
References: