Capsaicinoid Ingestion, Human Metabolism and Exercise (Phase 1)
|ClinicalTrials.gov Identifier: NCT02139852|
Recruitment Status : Unknown
Verified September 2015 by Dr. Jamie Burr, University of Prince Edward Island.
Recruitment status was: Active, not recruiting
First Posted : May 15, 2014
Last Update Posted : September 17, 2015
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
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel 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|
Dietary Supplement: Capsaicin
|Placebo Comparator: Placebo|
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02139852
|Canada, Prince Edward Island|
|Charlottetown, Prince Edward Island, Canada, C1A4P3|