None VolunteerCapsimaxNCT06612658
Acute Effect of Capsimax on Resistance Exercise Performance, Muscle Oxygenation, Nitric Oxide Release, Resting Energy Expenditure and Reaction Time
A study testing A novel, proprietary encapsulated form of Capsicum extract in beadlet form standardized to 2% capsaicinoids in people with None Volunteer, run by Hofstra University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men only
- Conditions the study is for
- None Volunteer
- What is being tested?
- A novel, proprietary encapsulated form of Capsicum extract in beadlet form standardized to 2% capsaicinoids
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2024to 30 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Hofstra University
Hempstead, New York, 11549
Adam M Gonzalez, PhD, 516-463-5224, adam.m.gonzalez@hofstra.edu
About this study
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
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).
Read more
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
Read the 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
- Conditions
- None Volunteer
- Being tested
- A novel, proprietary encapsulated form of Capsicum extract in beadlet form standardized to 2% capsaicinoids
- Keywords
- capsaicin, capsimax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A novel, proprietary encapsulated form of Capsicum extract in beadlet form standardized to 2% capsaicinoidsDietary supplement
Also called Capsimax, Capsaicin
This study will investigate the effect of the supplement on exercise performance.
| Study group | Role | What they receive |
|---|---|---|
| Capsimax | Experimental | Capsules containing either 100 mg Capsimax (OmniActive Health Technologies) Receives: Dietary Supplement: A novel, proprietary encapsulated form of Capsicum extract in beadlet form standardized to 2% capsaicinoids |
| Placebo | Placebo comparator | Microcrystalline cellulose Receives: Dietary Supplement: A novel, proprietary encapsulated form of Capsicum extract in beadlet form standardized to 2% capsaicinoids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resistance exercise performance
Performance during the barbell back squat exercise protocol (e.g., repetitions performed, total volume, peak power, average power).
Measured: 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
Measured: 1 day
Secondary outcomes (3)
Energy expenditure
Resting energy expenditure metrics
Measured: 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.
Measured: 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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start1 Oct 2024 (estimated)
- Primary completion30 May 2025 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for None VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, double-blind, placebo-controlled, cross-over study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hofstra University
- Sponsor type
- University, hospital or other
- Collaborators
- OmniActive Health Technologies
- Responsible party
- Principal investigator, Adam Gonzalez, Hofstra University
- Investigators
- Adam M Gonzalez, PhD, Principal investigator, Hofstra University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06612658
- Sponsor's protocol ID
- 20240805-AHK-SHS-GON-1
- Other IDs
- HO-01
- Acronym
- Capsimax
- Status last verified
- Sep 2024
- First submitted
- 10 Sep 2024
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06612658
- Acronym / sponsor ID
- Capsimax / 20240805-AHK-SHS-GON-1
- Conditions
- None Volunteer
- Keywords
- capsaicin, capsimax
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hofstra UniversityUniversity, hospital or other
- Collaborators
- OmniActive Health Technologies
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 25 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled, cross-over study
| Arm | Type | Receives |
|---|---|---|
| Capsimax | Experimental | Dietary Supplement: A novel, proprietary encapsulated form of Capsicum extract in beadlet form standardized to 2% capsaicinoidsCapsules containing either 100 mg Capsimax (OmniActive Health Technologies) |
| Placebo | Placebo comparator | Dietary Supplement: A novel, proprietary encapsulated form of Capsicum extract in beadlet form standardized to 2% capsaicinoidsMicrocrystalline cellulose |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A novel, proprietary encapsulated form of Capsicum extract in beadlet form standardized to 2% capsaicinoidsAlso: Capsimax, CapsaicinThis study will investigate the effect of the supplement on exercise performance. | Dietary supplement | Capsimax, Placebo |
Primary outcome
Resistance exercise performance
Time frame: 1 day
Performance during the barbell back squat exercise protocol (e.g., repetitions performed, total volume, peak power, average power).
Isometric strength test
Time frame: 1 day
Physical performance metrics will be assessed during an isometric mid-thigh pull test including peak power and rate of force development
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam M Gonzalez, PhD principal investigator
Hofstra University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A novel, proprietary encapsulated form of Capsicum extract in beadlet form standardized to 2% capsaicinoids in people with None Volunteer, run by Hofstra University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adam M Gonzalez, PhD (516-463-5224, adam.m.gonzalez@hofstra.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resistance exercise performance (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.