- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02139852
Capsaicinoid Ingestion, Human Metabolism and Exercise (Phase 1)
The Physiological Effects of Capsaicinoid Ingestion on Human Metabolism and Exercise Performance
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.
Study Overview
Detailed Description
Study Type
Contacts and Locations
Study Locations
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Prince Edward Island
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Charlottetown, Prince Edward Island, Canada, C1A4P3
- UPEI
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Other
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Energy substrate use (Fat vs Carbohydrate contributions to metabolism)
Time Frame: 10 weeks
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Expired gas analysis using a metabolic computer to calculate respiratory exchange rates.
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10 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiovascular risk factors
Time Frame: 10 weeks
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Vascular reactivity- endothelial function (Endopat), vascular stiffness (Pulse wave velocity), HRV (heart rate variability), Blood lipid/Glucose panel, blood pressure
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10 weeks
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Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OAHTCAPX-003-2014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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