This trial is active, not recruiting.

Condition metabolism
Treatment capsaicin
Phase phase 1
Sponsor University of Prince Edward Island
Collaborator OmniActive Health Technologies
Start date June 2014
End date January 2016
Trial size 40 participants
Trial identifier NCT02139852, OAHTCAPX-003-2014


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. 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.

The investigators seek to understand the effect of 3 months capsaicinoid ingestion on alterations in body composition, traditional cardiovascular risk factors and cardiovascular function


1) Continued use of capsaicinoids will alter resting metabolism substrate use, which will result in moderate (but clinically meaningful) alterations in body composition manifested as a decrease in adiposity. 2) Blood lipids will be unaffected by capsaicinoid use, as will brachial blood pressure. 3) Levels of systemic inflammation may increase slightly, and this could have an effect on vascular reactivity to hyperemic flow or baseline vascular tone. However, previous research suggests that these alterations will not be manifested in autonomic nervous tone assessed by changes in heart rate variability.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
(Placebo Comparator)

Primary Outcomes

Energy substrate use (Fat vs Carbohydrate contributions to metabolism)
time frame: 10 weeks

Secondary Outcomes

Cardiovascular risk factors
time frame: 10 weeks

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.