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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: None Volunteer
• Intervention / Treatment: Dietary supplement: A novel, proprietary encapsulated form of Capsicum extract in beadlet form standardized to 2% capsaicinoids

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

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adam M Gonzalez, PhD; Phone Number: 516-463-5224; Email: adam.m.gonzalez@hofstra.edu

Study Locations

• United States
  • New York
    • Hempstead, New York, United States, 11549
      • Hofstra University
      • Contact: Adam M Gonzalez, PhD; Phone Number: 516-463-5224; Email: adam.m.gonzalez@hofstra.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Microcrystalline cellulose	Dietary supplement: A novel, proprietary encapsulated form of Capsicum extract in beadlet form standardized to 2% capsaicinoids; This study will investigate the effect of the supplement on exercise performance.; Other Names: Capsaicin; Capsimax
Experimental: Capsimax; Capsules containing either 100 mg Capsimax (OmniActive Health Technologies)	Dietary supplement: A novel, proprietary encapsulated form of Capsicum extract in beadlet form standardized to 2% capsaicinoids; This study will investigate the effect of the supplement on exercise performance.; Other Names: Capsaicin; Capsimax

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resistance exercise performance	Performance during the barbell back squat exercise protocol (e.g., repetitions performed, total volume, peak power, average power).	1 day
Isometric strength test	Physical performance metrics will be assessed during an isometric mid-thigh pull test including peak power and rate of force development	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Energy expenditure	Resting energy expenditure metrics	1 day
Nitric oxide release and skeletal muscle oxygenation	Prior to initiating the barbell back squat exercise protocol, participants will have a sensor (NNOXX One, NNOXX Inc.) secured to a standardized position on the thigh to measure nitric oxide release and muscle oxygenation (i.e., a measure of how much blood and oxygen is being delivered to the working muscle) during exercise. This is a non-invasive device that adheres to the skin with tape and allows for real-time feedback regarding the status of the muscle (Figure 1). NNOXX One utilizes spectrometer and optical sensors to non-invasively measure muscle oxygenation and nitric oxide by analyzing the absorption and reflection of light interacting with bodily tissues.	1 day
Subjective feelings of pain and rating of perceived exertion	Questionnaires will be provided prior to supplementation, prior to exercise, and following the resistance exercise protocol. Participants will be instructed to assess their subjective feelings of fatigue and pain using a 15-cm visual analog scale (VAS). The scale will be anchored by the words "low" and "high" to represent extreme ratings where the greater measured value represents a greater feeling. Questions will be structured as "My level of fatigue is." Participants will be asked to rate their feelings at each time point by marking on the corresponding line. A rating of perceived exertion (RPE) will also be recorded following the resistance exercise protocol.	1 day

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reaction time	Reaction time will be assessed with a visual-cognitive reactionary test	1 day

Collaborators and Investigators

• Sponsor: Hofstra University
• Collaborators: OmniActive Health Technologies
• Investigators: Principal Investigator: Adam M Gonzalez, PhD, Hofstra University

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): May 30, 2025
• Study Completion (Estimated): May 30, 2025

Study Registration Dates

• First Submitted: September 10, 2024
• First Submitted That Met QC Criteria: September 22, 2024
• First Posted (Actual): September 25, 2024

Study Record Updates

• Last Update Posted (Actual): September 25, 2024
• Last Update Submitted That Met QC Criteria: September 22, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: capsaicin; capsimax
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Dermatologic Agents; Antipruritics; Capsaicin
• Other Study ID Numbers: 20240805-AHK-SHS-GON-1; HO-01 (Other Grant/Funding Number: OmniActive Health Technologies)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No