Capsaicinoid Ingestion, Human Metabolism and Exercise (Phase 1)

• ClinicalTrials.gov Identifier: NCT02139852
• Recruitment Status: Unknown
• First Posted: May 15, 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. 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.

Condition or disease	Intervention/treatment	Phase
Metabolism	Dietary Supplement: Capsaicin	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
Experimental: capsaicin; Capsaicin	Dietary Supplement: Capsaicin
Placebo Comparator: Placebo

Outcome Measures

Primary Outcome Measures :

1. Energy substrate use (Fat vs Carbohydrate contributions to metabolism) [ Time Frame: 10 weeks ]
   Expired gas analysis using a metabolic computer to calculate respiratory exchange rates.

Secondary Outcome Measures :

1. Cardiovascular risk factors [ Time Frame: 10 weeks ]
   Vascular reactivity- endothelial function (Endopat), vascular stiffness (Pulse wave velocity), HRV (heart rate variability), Blood lipid/Glucose panel, blood pressure

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: NCT02139852
• Other Study ID Numbers: OAHTCAPX-003-2014
• First Posted: May 15, 2014
• Last Update Posted: September 17, 2015
• Last Verified: September 2015

Additional relevant MeSH terms:

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