Capsaicinoid Ingestion, Human Metabolism and Exercise

Metabolism Clinical Trial

— Phase 1  

Official title:

The Physiological Effects of Capsaicinoid Ingestion on Human Metabolism and Exercise Performance

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02139852
• Other study ID #: OAHTCAPX-003-2014
• Status: Withdrawn
• Start date: June 2014
• Est. completion date: January 2016

Study information

• Verified date: June 2022
• Source: University of Prince Edward Island
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Description:

Project abandoned

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolism

Intervention

Dietary Supplement:
• Capsaicin

Locations

Country	Name	City	State
Canada	UPEI	Charlottetown	Prince Edward Island

Sponsors (2)

Lead Sponsor	Collaborator
University of Prince Edward Island	OmniActive Health Technologies

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Energy substrate use (Fat vs Carbohydrate contributions to metabolism)	Expired gas analysis using a metabolic computer to calculate respiratory exchange rates.	10 weeks
Secondary	Cardiovascular risk factors	Vascular reactivity- endothelial function (Endopat), vascular stiffness (Pulse wave velocity), HRV (heart rate variability), Blood lipid/Glucose panel, blood pressure	10 weeks