The Acute Effects of Capsiate During Exercise

NCT00692601 | Completed Phase 1

• 2 other identifiers: REB 07-410NHPD#:130269
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Acute Exercise protocol; Crossover design; Oxygen consumption (VO2); Respiratory Exchange Ratio (RER); Adrenergic System Agonism; Capsiate Natura; Young; Male

Outcome Measures

Primary Outcomes (1)

• Respiratory Exchange Ratio (RER) for substrate use

  breath by breath analysis of oxygen uptake and carbon dioxide release (recorded as the average oxygen uptake and carbon dioxide relsease every 30 seconds)

Secondary Outcomes (4)

• Heart Rate

  measured 8 times over 180 minutes

• Blood Pressure monitoring

  measured 8 times over 180 minutes

• Blood biomarkers (blood glucose, glycerol, lactate, Free fatty acids [FFA])

  measured 6 times over 180 minutes

• Plasma Catecholamines (Epinephrine, norepinephrine)

  measured 6 times over 180 minutes

Study Arms (3)

1

EXPERIMENTAL

acute oral ingestion of 3 mg capsiate

Dietary Supplement: Acute consumption of Capsiate Natura

2

EXPERIMENTAL

acute oral ingestion of 10 mg capsiate

Dietary Supplement: Acute consumption of Capsiate Natura

3

PLACEBO COMPARATOR

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

Interventions

Acute consumption of Capsiate Natura DIETARY_SUPPLEMENT

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.

Also known as: Brand: Capsiate Natura, Capsinoid

1

Acute ingestion of identical placebo capsules DIETARY_SUPPLEMENT

10 mg placebo = 0 mg total capsiate. Consumed ONCE orally as capsules 30 minutes before starting to exercise. Each capsule contains 1 mg capsiate.

3

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• Ajinomoto USA, INC.: collaborator

Study Sites (1)

Exercise Metabolism Research Laboratory, McMaster Univeristy

Hamilton, Ontario, L8S 4K1, Canada

Location

Related Publications (4)

• Masuda Y, Haramizu S, Oki K, Ohnuki K, Watanabe T, Yazawa S, Kawada T, Hashizume S, Fushiki T. Upregulation of uncoupling proteins by oral administration of capsiate, a nonpungent capsaicin analog. J Appl Physiol (1985). 2003 Dec;95(6):2408-15. doi: 10.1152/japplphysiol.00828.2002. Epub 2003 Sep 5.

  PMID: 12959953 BACKGROUND

• Ohnuki K, Haramizu S, Oki K, Watanabe T, Yazawa S, Fushiki T. Administration of capsiate, a non-pungent capsaicin analog, promotes energy metabolism and suppresses body fat accumulation in mice. Biosci Biotechnol Biochem. 2001 Dec;65(12):2735-40. doi: 10.1271/bbb.65.2735.

  PMID: 11826971 BACKGROUND

• Ohnluki K, Haramizu S, Watanabe T, Yazawa S, Fushiki T. CH-19 sweet, nonpungent cultivar of red pepper, increased body temperature in mice with vanilloid receptors stimulation by capsiate. J Nutr Sci Vitaminol (Tokyo). 2001 Aug;47(4):295-8. doi: 10.3177/jnsv.47.295.

  PMID: 11767210 BACKGROUND

• Ohnuki K, Niwa S, Maeda S, Inoue N, Yazawa S, Fushiki T. CH-19 sweet, a non-pungent cultivar of red pepper, increased body temperature and oxygen consumption in humans. Biosci Biotechnol Biochem. 2001 Sep;65(9):2033-6. doi: 10.1271/bbb.65.2033.

  PMID: 11676017 BACKGROUND

Study Officials

• Stuart M Phillips, Ph.D.

  Department of Kinesiology, McMaster University

  PRINCIPAL INVESTIGATOR

• Andrea R Josse, M.Sc.

  Department of Kinesiology, McMaster University

  STUDY DIRECTOR

• Nicholas A Burd, M.Sc.

  Department of Kinesiology, McMaster University

  STUDY DIRECTOR

• Yoshiyuki Fujishima, D.Phil.

  Ajinomoto USA, INC.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 4, 2008
• First Posted: June 6, 2008
• Study Start: April 1, 2008
• Primary Completion: July 1, 2008
• Study Completion: September 1, 2008
• Last Updated: September 16, 2008

Record last verified: 2008-06

Locations

CA (1)