Capsaicinoid Ingestion, Human Metabolism and Exercise (Phase 2)

NCT02138630 | Withdrawn

• 1 other identifier: OAHTCAPX-003-2014-2
• Study Type: interventional
• 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. 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.

Conditions

Metabolism; Exercise

Keywords

Exercise

Outcome Measures

Primary Outcomes (1)

• Performance

  Exercise: Time to exhaustion on a cycle ergometer at controlled relative intensity

  2 to 4 hours

Secondary Outcomes (1)

• Substrate Use

  2 to 4 hours

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Capsaicin

EXPERIMENTAL

Single Capsule, "Capsimax" 100 mg, ingested 60 min prior to exercise

Dietary Supplement: Capsaicin

Interventions

Capsaicin DIETARY_SUPPLEMENT

Also known as: Capsimax

Capsaicin

Placebo DIETARY_SUPPLEMENT

Sugar capsule

Placebo

Eligibility Criteria

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

You may qualify if:

• 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

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

Conditions

Motor Activity

Interventions

Capsaicin

Condition Hierarchy (Ancestors)

Behavior

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: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 8, 2014
• First Posted: May 14, 2014
• Study Start: June 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: June 22, 2022

Record last verified: 2015-09

Locations

CA (1)