Acute Effect of Capsimax on Resistance Exercise Performance, Muscle Oxygenation, Nitric Oxide Release, Resting Energy Expenditure and Reaction Time
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: A novel, proprietary encapsulated form of Capsicum extract in beadlet form standardized to 2% capsaicinoids.
- Who it may be relevant to
- Registry conditions: None Volunteer. Basic parameters: 18 years — 35 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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
Interventions
- 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.
Primary outcome measures
- Resistance exercise performance [Time frame: 1 day]
- Isometric strength test [Time frame: 1 day]
Secondary outcome measures (3)
- Energy expenditure [Time frame: 1 day]
- Nitric oxide release and skeletal muscle oxygenation [Time frame: 1 day]
- Subjective feelings of pain and rating of perceived exertion [Time frame: 1 day]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Triple blind
- Primary purpose
- Other
Study locations
United States · 1 center
- Hofstra University — Hempstead
Identifiers
NCT: NCT06612658 · 20240805-AHK-SHS-GON-1 · HO-01