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Capsaicinoid Ingestion, Human Metabolism and Exercise (Phase 2)

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ClinicalTrials.gov Identifier: NCT02138630
Recruitment Status : Unknown
Verified September 2015 by Dr. Jamie Burr, University of Prince Edward Island.
Recruitment status was:  Active, not recruiting
First Posted : May 14, 2014
Last Update Posted : September 17, 2015
Sponsor:
Collaborator:
OmniActive Health Technologies
Information provided by (Responsible Party):
Dr. Jamie Burr, University of Prince Edward Island

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Metabolism Exercise Dietary Supplement: Capsaicin Dietary Supplement: Placebo Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Official Title: The Physiological Effects of Capsaicinoid Ingestion on Human Metabolism and Exercise Performance
Study Start Date : June 2014
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Capsaicin

Arm Intervention/treatment
Placebo Comparator: Placebo Dietary Supplement: Placebo
Sugar capsule

Experimental: Capsaicin
Single Capsule, "Capsimax" 100 mg, ingested 60 min prior to exercise
Dietary Supplement: Capsaicin
Other Name: Capsimax




Primary Outcome Measures :
  1. Performance [ Time Frame: 2 to 4 hours ]
    Exercise: Time to exhaustion on a cycle ergometer at controlled relative intensity


Secondary Outcome Measures :
  1. Substrate Use [ Time Frame: 2 to 4 hours ]
    Measurement of expired gases



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02138630


Locations
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Canada, Prince Edward Island
UPEI
Charlottetown, Prince Edward Island, Canada, C1A4P3
Sponsors and Collaborators
University of Prince Edward Island
OmniActive Health Technologies
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Responsible Party: Dr. Jamie Burr, Assistant Professor, University of Prince Edward Island
ClinicalTrials.gov Identifier: NCT02138630    
Other Study ID Numbers: OAHTCAPX-003-2014-2
First Posted: May 14, 2014    Key Record Dates
Last Update Posted: September 17, 2015
Last Verified: September 2015
Keywords provided by Dr. Jamie Burr, University of Prince Edward Island:
Exercise
Additional relevant MeSH terms:
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Capsaicin
Antipruritics
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs