Acute Effect of Capsimax on Resistance Exercise Performance, Muscle Oxygenation, Nitric Oxide Release, Resting Energy Expenditure and Reaction Time

Hofstra University

Status: Not yet enrolling

Conditions: None Volunteer

Treatments: Dietary Supplement: A novel, proprietary encapsulated form of Capsicum extract in beadlet form standardized to 2% capsaicinoids

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06612658

20240805-AHK-SHS-GON-1

HO-01 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full 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

Enrollment: 40 estimated patients

Sex: Male

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

40 participants in 2 patient groups, including a placebo group

Capsimax

Experimental group

Description:

Capsules containing either 100 mg Capsimax (OmniActive Health Technologies)

Treatment:

Dietary Supplement: A novel, proprietary encapsulated form of Capsicum extract in beadlet form standardized to 2% capsaicinoids

Placebo

Placebo Comparator group

Description:

Microcrystalline cellulose

Treatment:

Dietary Supplement: A novel, proprietary encapsulated form of Capsicum extract in beadlet form standardized to 2% capsaicinoids