MetabolismNCT02138630
Capsaicinoid Ingestion, Human Metabolism and Exercise (Phase 2)
A study testing Capsaicin in people with Metabolism and Exercise, run by University of Prince Edward Island at 1 site in Canada.
Trial summary
Capsaicinoids (the active ingredient in hot peppers) have been shown to cause a moderate increase in energy expenditure (50 kcal/day) as well as reductions in appetite, energy intake, and (visceral) adiposity. As such, there is considerable interest in capsaicinoid for weight loss supplements. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolism, Exercise
- What is being tested?
- Capsaicin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2014to Jan 2016
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects will be male or female, 18 yr -45yr and free from any known or suspected chronic conditions. General health and suitability to participate in an exercise/health research study will be confirmed through use of the PAR-Q+ screening questionnaire
Who cannot join
- Any participant who has a positive answer to a screening question will be required to seek physician approval prior to any physical exercise. Baseline arrhythmia (tachycardia (>100pbm) and systolic or diastolic hypertension (>140/90 mmHg) will also be reason for exclusion. During baseline anthropometric assessment we will confirm that participants all fall within a typical BMI range (20-30 kg/m2) of either "normal" weight or "overweight", but not "underweight" or "obese". Persons who take cardiovascular medications, metabolic medications, smoke cigarettes, excessively consume alcohol, are prone to heartburn, or have a previous diagnosis of hyperlipidemia or hyperinsulemia will also be excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Physiological Effects of Capsaicinoid Ingestion on Human Metabolism and Exercise Performance
Capsaicinoids (the active ingredient in hot peppers) have been shown to cause a moderate increase in energy expenditure (50 kcal/day) as well as reductions in appetite, energy intake, and (visceral) adiposity. As such, there is considerable interest in capsaicinoid for weight loss supplements. Owing to the fact that these changes are believed to be driven by catecholamine release and alterations in fat oxidation, there is growing belief that capsaicin may also offer potential ergogenic benefits (performance enhancement) during exercise, similar to the affect of caffeine, which works through similar pathways. Of particular interest are the recent findings that free-fatty acids in the blood are elevated 2-2.5hrs post ingestion, yet changes in typical cardiovascular or sympathetic nervous tone indicators (heart rate, blood pressure) were unaffected, suggesting some of the negative consequences of other stimulants may be avoided. At present, however, more in depth investigations of the effects on endothelial function, vascular autonomic tone and inflammation are lacking.
Although there are some indications that capsaicinoid ingestion may alter factors associated exercise performance (such as increased fat oxidation for glucose sparing), to date these studies have primarily used very low exercise intensities wherein these effects are typically unnecessary, and results are not generalizable to the typical race intensities of endurance sport competition. Performance measures have also been a noticeably absent outcome from research to date.
Hypotheses: 1), Exercise performance will improve, at a level similar to those demonstrated for caffeine ingestion 2) ratings of perceived exertion will go down with the effect of causing intensity to go up 3) During sustained aerobic activity approaching the aerobic threshold alterations in substrate use will be minimal (but possibly meaningful in regard to performance); alterations at rest will be more pronounced. 4) acute alterations (6o min post single dose) in blood pressure, HRV, arterial stiffness and RMR will mirror the effects observed for more prolonged exposure in phase 1.
- Conditions
- Metabolism, Exercise
- Being tested
- Capsaicin, Placebo
- Keywords
- Exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapsaicinDietary supplement
Also called Capsimax
PlaceboDietary supplement
Sugar capsule
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
| Capsaicin | Experimental | Single Capsule, "Capsimax" 100 mg, ingested 60 min prior to exercise Receives: Dietary Supplement: Capsaicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance
Exercise: Time to exhaustion on a cycle ergometer at controlled relative intensity
Measured: 2 to 4 hours
Secondary outcomes (1)
Substrate Use
Measurement of expired gases
Measured: 2 to 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2014 (estimated)
- Study startJun 2014
- Primary completionJan 2016 (estimated)
- Study completionJan 2016 (estimated)
Why it stopped: Project abandoned
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MetabolismStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Prince Edward Island
- Sponsor type
- University, hospital or other
- Collaborators
- OmniActive Health Technologies
- Responsible party
- Principal investigator, Dr. Jamie Burr, University of Prince Edward Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02138630
- Sponsor's protocol ID
- OAHTCAPX-003-2014-2
- Status last verified
- Sep 2015
- First submitted
- 8 May 2014
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Physiological Effects of Capsaicinoid Ingestion on Human Metabolism and Exercise Performance
- ClinicalTrials.gov ID
- NCT02138630
- Acronym / sponsor ID
- OAHTCAPX-003-2014-2
- Conditions
- Metabolism, Exercise
- Keywords
- Exercise
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Project abandoned
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Prince Edward IslandUniversity, hospital or other
- Collaborators
- OmniActive Health Technologies
- Study start
- Jun 2014
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 14 May 2014 (estimated)
- 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.
Capsaicinoids (the active ingredient in hot peppers) have been shown to cause a moderate increase in energy expenditure (50 kcal/day) as well as reductions in appetite, energy intake, and (visceral) adiposity. As such, there is considerable interest in capsaicinoid for weight loss supplements. Owing to the fact that these changes are believed to be driven by catecholamine release and alterations in fat oxidation, there is growing belief that capsaicin may also offer potential ergogenic benefits (performance enhancement) during exercise, similar to the affect of caffeine, which works through similar pathways. Of particular interest are the recent findings that free-fatty acids in the blood are elevated 2-2.5hrs post ingestion, yet changes in typical cardiovascular or sympathetic nervous tone indicators (heart rate, blood pressure) were unaffected, suggesting some of the negative consequences of other stimulants may be avoided. At present, however, more in depth investigations of the effects on endothelial function, vascular autonomic tone and inflammation are lacking.
Although there are some indications that capsaicinoid ingestion may alter factors associated exercise performance (such as increased fat oxidation for glucose sparing), to date these studies have primarily used very low exercise intensities wherein these effects are typically unnecessary, and results are not generalizable to the typical race intensities of endurance sport competition. Performance measures have also been a noticeably absent outcome from research to date.
Hypotheses: 1), Exercise performance will improve, at a level similar to those demonstrated for caffeine ingestion 2) ratings of perceived exertion will go down with the effect of causing intensity to go up 3) During sustained aerobic activity approaching the aerobic threshold alterations in substrate use will be minimal (but possibly meaningful in regard to performance); alterations at rest will be more pronounced. 4) acute alterations (6o min post single dose) in blood pressure, HRV, arterial stiffness and RMR will mirror the effects observed for more prolonged exposure in phase 1.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
| Capsaicin | Experimental | Dietary Supplement: CapsaicinSingle Capsule, "Capsimax" 100 mg, ingested 60 min prior to exercise |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Subjects will be male or female, 18 yr -45yr and free from any known or suspected chronic conditions. General health and suitability to participate in an exercise/health research study will be confirmed through use of the PAR-Q+ screening questionnaire
Key exclusion criteria (1 listed)
- Any participant who has a positive answer to a screening question will be required to seek physician approval prior to any physical exercise. Baseline arrhythmia (tachycardia (>100pbm) and systolic or diastolic hypertension (>140/90 mmHg) will also be reason for exclusion. During baseline anthropometric assessment we will confirm that participants all fall within a typical BMI range (20-30 kg/m2) of either "normal" weight or "overweight", but not "underweight" or "obese". Persons who take cardiovascular medications, metabolic medications, smoke cigarettes, excessively consume alcohol, are prone to heartburn, or have a previous diagnosis of hyperlipidemia or hyperinsulemia will also be excluded
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 |
|---|---|---|
| CapsaicinAlso: Capsimax | Dietary supplement | Capsaicin |
| PlaceboSugar capsule | Dietary supplement | Placebo |
Primary outcome
Performance
Time frame: 2 to 4 hours
Exercise: Time to exhaustion on a cycle ergometer at controlled relative intensity
1 secondary outcome
Substrate Use
Time frame: 2 to 4 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Capsaicin in people with Metabolism and Exercise, run by University of Prince Edward Island at 1 site in Canada.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 22 Jun 2022. 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 Canada. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance (time frame: 2 to 4 hours). 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 22 Jun 2022.