Clinical trial NCT02139852: Capsaicinoid Ingestion, Human Metabolism and Exercise
Official title: The Physiological Effects of Capsaicinoid Ingestion on Human Metabolism and Exercise Performance
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Metabolism
Lead sponsor: University of Prince Edward Island
Sponsor class: OTHER
Collaborators: name: OmniActive Health Technologies
First posted: 2014-05-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Project abandoned

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. 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

Hypotheses:

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.

Detailed description: Project abandoned

Eligibility 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

Primary outcomes:
measure: Energy substrate use (Fat vs Carbohydrate contributions to metabolism)
timeFrame: 10 weeks
Secondary outcomes:
measure: Cardiovascular risk factors
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Charlottetown
country: Canada
facility: UPEI
state: Prince Edward Island
Study officials:
References: