Overview

This trial is active, not recruiting.

Conditions metabolism, exercise
Treatments capsaicin, placebo
Phase phase 0
Sponsor University of Prince Edward Island
Collaborator OmniActive Health Technologies
Start date June 2014
End date January 2016
Trial size 15 participants
Trial identifier NCT02138630, OAHTCAPX-003-2014-2

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking double blind (subject, outcomes assessor)
Arm
(Placebo Comparator)
placebo
Sugar capsule
(Experimental)
Single Capsule, "Capsimax" 100 mg, ingested 60 min prior to exercise
capsaicin Capsimax

Primary Outcomes

Measure
Performance
time frame: 2 to 4 hours

Secondary Outcomes

Measure
Substrate Use
time frame: 2 to 4 hours

Eligibility Criteria

Male or female participants from 18 years up to 45 years old.

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

Additional Information

Official title The Physiological Effects of Capsaicinoid Ingestion on Human Metabolism and Exercise Performance
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by University of Prince Edward Island.