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Capsaicinoid Ingestion, Human Metabolism and Exercise (Phase 1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborator:
OmniActive Health Technologies
Information provided by (Responsible Party):
Dr. Jamie Burr, University of Prince Edward Island

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

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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

Resource links provided by the National Library of Medicine

Drug Information available for: Capsaicin

Arm Intervention/treatment
Experimental: capsaicin
Capsaicin
Dietary Supplement: Capsaicin
Placebo Comparator: Placebo



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



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02139852


Locations
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Canada, Prince Edward Island
UPEI
Charlottetown, Prince Edward Island, Canada, C1A4P3
Sponsors and Collaborators
University of Prince Edward Island
OmniActive Health Technologies
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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    Key Record Dates
Last Update Posted: September 17, 2015
Last Verified: September 2015
Additional relevant MeSH terms:
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Capsaicin
Antipruritics
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs