Capsaicinoid Ingestion, Human Metabolism and Exercise

NCT02139852 | Withdrawn

• 1 other identifier: OAHTCAPX-003-2014
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolism

Outcome Measures

Primary Outcomes (1)

• Energy substrate use (Fat vs Carbohydrate contributions to metabolism)

  Expired gas analysis using a metabolic computer to calculate respiratory exchange rates.

  10 weeks

Secondary Outcomes (1)

• Cardiovascular risk factors

  10 weeks

Interventions

Capsaicin DIETARY_SUPPLEMENT

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Project abandoned

You may qualify if:

• Subjects will be male or female
• 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

You may not qualify if:

• Any participant who has a positive answer to a screening question will be required to seek physician approval prior to any physical exercise.
• 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

Sponsors & Collaborators

• University of Prince Edward Island: lead
• OmniActive Health Technologies: collaborator

Study Sites (1)

UPEI

Charlottetown, Prince Edward Island, C1A4P3, Canada

Location

MeSH Terms

Interventions

Capsaicin

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 6, 2014
• First Posted: May 15, 2014
• Study Start: June 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: June 23, 2022

Record last verified: 2022-06

Locations

CA (1)