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The Acute Effects of Capsiate During Exercise

This study has been completed.
Sponsor:
Collaborator:
Ajinomoto USA, INC.
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00692601
First received: June 4, 2008
Last updated: September 15, 2008
Last verified: June 2008
  Purpose

Capsiate is a non-pungent analogue of capsaicin, the component of hot peppers that makes them hot or spicy. Unlike capsaicin, capsiate is not spicy or hot. Ingestion of capsiate has been shown to increase resting oxygen consumption, body temperature, and the burning of fat. As such, capsiate appears to act in a manner similar to that of many other substances that energize us, increase our alertness and cause a rushing feeling by affecting a system in our body that is responsible for the release of adrenaline. The major difference, however, is that capsiate is broken down in the stomach into two components: vanilla and a fatty acid, and is not absorbed as capsiate into the blood stream at all. This implies that the way capsiate works is likely by acting on the cells in the gut (before it is broken down)rather than affecting all other cells in the body as it would do if it ended up in the blood. Therefore, the gut cells are thought to be the ones responsible for triggering the full-body adrenaline response. In any case, the use of capsiate has been shown to be effective in preventing weight gain and as such it may represent a possible therapy for treating obesity. Many obesity-related programs not involving medication advocate the use of diet and/or exercise. However, one of the biggest problems with weight loss from dieting alone is a general decrease in our body's ability to burn the food we eat as energy. This very problem is the reason for why people turn to adrenaline-releasing drugs like caffeine and ephedra. Unfortunately though, if too much is consumed, there is a high risk of bad side-effects. However, low dose caffeine/ephedra compounds (that are within specified FDA limits) have recently been reported to be effective. Moreover, these compounds are used with great frequency by people attempting to lose weight.

Given that capsiate increases body temperature, promotes the burning of body fat and has an exceptionally great side-effect profile, it looks to be a very effective supplement for use in treatment of obesity and overweight. As such, it would be important to test this supplement along with exercise. This is because consuming capsiate with exercise may enhance its effectiveness in increasing the burning of body fat. The primary purpose of this study is to examine the response of young healthy males to a 90 minute bout of moderate intensity cycling after having consumed 0 mg, 3 mg, or 10 mg of capsiate.


Condition Intervention Phase
Healthy
Dietary Supplement: Acute consumption of Capsiate Natura
Dietary Supplement: Acute ingestion of identical placebo capsules
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effect of Differing Doses of A Sweet Pepper Extract - Capsiate (A Capsaicin Analogue) - On Energy Expenditure and Blood Parameters in Humans During Exercise

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Respiratory Exchange Ratio (RER) for substrate use [ Time Frame: breath by breath analysis of oxygen uptake and carbon dioxide release (recorded as the average oxygen uptake and carbon dioxide relsease every 30 seconds) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Heart Rate [ Time Frame: measured 8 times over 180 minutes ] [ Designated as safety issue: No ]
  • Blood Pressure monitoring [ Time Frame: measured 8 times over 180 minutes ] [ Designated as safety issue: No ]
  • Blood biomarkers (blood glucose, glycerol, lactate, Free fatty acids [FFA]) [ Time Frame: measured 6 times over 180 minutes ] [ Designated as safety issue: No ]
  • Plasma Catecholamines (Epinephrine, norepinephrine) [ Time Frame: measured 6 times over 180 minutes ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: April 2008
Study Completion Date: September 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
acute oral ingestion of 3 mg capsiate
Dietary Supplement: Acute consumption of Capsiate Natura
10 capsules = 3 mg total capsiate. Consumed ONCE orally as capsules 30 minutes before starting to exercise. 3 active capsules containing 1 mg capsiate each and 7 placebo capsules.
Other Name: Brand: Capsiate Natura, Capsinoid
Experimental: 2
acute oral ingestion of 10 mg capsiate
Dietary Supplement: Acute consumption of Capsiate Natura
10 capsules = 10 mg total capsiate. Consumed ONCE orally as capsules 30 minutes before starting to exercise. Each capsule contains 1 mg capsiate.
Other Name: Brand: Capsiate Natura
Placebo Comparator: 3
acute oral ingestion of 0 mg capsiate ( same number of capsules as two other trials and identical looking placebo capsules)
Dietary Supplement: Acute ingestion of identical placebo capsules
10 mg placebo = 0 mg total capsiate. Consumed ONCE orally as capsules 30 minutes before starting to exercise. Each capsule contains 1 mg capsiate.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy men
  • Recreationally active
  • Non-smokers
  • Age 18-30 years
  • Favourable (low risk) answers on Standard Health Questionnaire (part of approved consent form)
  • Peak VO2 of > 40 ml/kg/min
  • Recruited from the local McMaster University campus or surrounding community.

Exclusion Criteria:

  • Women
  • Smokers
  • Contraindicated health conditions which would render someone "clinically" unhealthy i.e. diabetes, liver, kidney abnormalities, etc.
  • Possible allergies to the study products (Capsiate or Placebo)
  • The use of foods, other natural health products or pharmaceuticals that may interact with the study products
  • The use of natural health products that alter the outcome measures of the trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00692601

Locations
Canada, Ontario
Exercise Metabolism Research Laboratory, McMaster Univeristy
Hamilton, Ontario, Canada, L8S 4K1
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Ajinomoto USA, INC.
Investigators
Principal Investigator: Stuart M Phillips, Ph.D. Department of Kinesiology, McMaster University
Study Director: Andrea R Josse, M.Sc. Department of Kinesiology, McMaster University
Study Director: Nicholas A Burd, M.Sc. Department of Kinesiology, McMaster University
Study Chair: Yoshiyuki Fujishima, D.Phil. Ajinomoto USA, INC.
  More Information

Publications:
Responsible Party: Stuart M Phillips, Associate Professor, Department of Kinesiology, McMaster University
ClinicalTrials.gov Identifier: NCT00692601     History of Changes
Other Study ID Numbers: REB 07-410, NHPD#:130269
Study First Received: June 4, 2008
Last Updated: September 15, 2008
Health Authority: Canada: Health Canada

Keywords provided by McMaster University:
Acute Exercise protocol
Crossover design
Oxygen consumption (VO2)
Respiratory Exchange Ratio (RER)
Adrenergic System Agonism
Capsiate Natura
Young
Male

ClinicalTrials.gov processed this record on November 20, 2014