Capsaicinoid Ingestion, Human Metabolism and Exercise (Phase 2)

• ClinicalTrials.gov Identifier: NCT02138630
• Recruitment Status: Unknown
• First Posted: May 14, 2014
• Last Update Posted: September 17, 2015
• Sponsor: University of Prince Edward Island
• Collaborator: OmniActive Health Technologies
• Information provided by (Responsible Party): Dr. Jamie Burr, University of Prince Edward Island

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Metabolism; Exercise	Dietary Supplement: Capsaicin; Dietary Supplement: Placebo	Early Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Official Title: The Physiological Effects of Capsaicinoid Ingestion on Human Metabolism and Exercise Performance
• Study Start Date: June 2014
• Estimated Primary Completion Date: January 2016
• Estimated Study Completion Date: January 2016

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Placebo	Dietary Supplement: Placebo; Sugar capsule
Experimental: Capsaicin; Single Capsule, "Capsimax" 100 mg, ingested 60 min prior to exercise	Dietary Supplement: Capsaicin; Other Name: Capsimax

Outcome Measures

Primary Outcome Measures :

1. Performance [ Time Frame: 2 to 4 hours ]
   Exercise: Time to exhaustion on a cycle ergometer at controlled relative intensity

Secondary Outcome Measures :

1. Substrate Use [ Time Frame: 2 to 4 hours ]
   Measurement of expired gases

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

Canada, Prince Edward Island

UPEI

Charlottetown, Prince Edward Island, Canada, C1A4P3

Sponsors and Collaborators

University of Prince Edward Island

OmniActive Health Technologies

More Information

• Responsible Party: Dr. Jamie Burr, Assistant Professor, University of Prince Edward Island
• ClinicalTrials.gov Identifier: NCT02138630
• Other Study ID Numbers: OAHTCAPX-003-2014-2
• First Posted: May 14, 2014
• Last Update Posted: September 17, 2015
• Last Verified: September 2015

Keywords provided by Dr. Jamie Burr, University of Prince Edward Island:

Exercise

Additional relevant MeSH terms:

Capsaicin; Antipruritics; Dermatologic Agents; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs