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

NCT06612658 | Not Yet Recruiting

• 2 other identifiers: 20240805-AHK-SHS-GON-1HO-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

None Volunteer

Keywords

capsaicin; capsimax

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Energy expenditure

  1 day

• Nitric oxide release and skeletal muscle oxygenation

  1 day

• Subjective feelings of pain and rating of perceived exertion

  1 day

Other Outcomes (1)

• Reaction time

  1 day

Study Arms (2)

Capsimax

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Microcrystalline cellulose

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

Interventions

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

This study will investigate the effect of the supplement on exercise performance.

Also known as: Capsimax, Capsaicin

Capsimax; Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hofstra University: lead
• OmniActive Health Technologies: collaborator

Study Sites (1)

Hofstra University

Hempstead, New York, 11549, United States

Location

MeSH Terms

Interventions

Capsaicin

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Study Officials

• Adam M Gonzalez, PhD

  Hofstra University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adam M Gonzalez, PhD

CONTACT

516-463-5224; adam.m.gonzalez@hofstra.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized, double-blind, placebo-controlled, cross-over study

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 25, 2024
• Study Start: October 1, 2024
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: September 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)