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Effect of Chili Pepper Extract on Weight and Fat Loss and Metabolism Increase

This study has been completed.
Sponsor:
Information provided by:
Ajinomoto USA, INC.
ClinicalTrials.gov Identifier:
NCT00825838
First received: January 18, 2009
Last updated: January 20, 2009
Last verified: January 2009
History of Changes
  Purpose

The purpose of this study is to test the safety and effectiveness of a purified extract of CH-19 Sweet, containing capsinoids.


Condition Intervention Phase
Overweight
Obesity
 Dietary Supplement: Chronic consumption of chili pepper extract
Dietary Supplement: Chronic consumption of matching placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Double-Blind Placebo-Controlled Clinical Trial of a Purified Chili Pepper Extract (CH-19 Sweet Extract) to Evaluate Its Safety and Efficacy for Weight and Fat Loss and Metabolism Change in Overweight or Obese Healthy Male and Female Adults

Resource links provided by NLM:

MedlinePlus related topics: Obesity
Drug Information available for: Capsicum
U.S. FDA Resources

Further study details as provided by Ajinomoto USA, INC.:

Primary Outcome Measures:
  • body weight and body composition [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • resting metabolic rate and substrate oxidation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: April 2006
Study Completion Date: March 2007
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Oral ingestion of 6mg chili pepper extract
 Dietary Supplement: Chronic consumption of chili pepper extract
6mg chili pepper extract per day in two divided doses (before the morning meal and before the evening meal) up to 12 weeks.
Placebo Comparator: 2
Oral ingestion of 0 mg chili pepper extract (matching placebo)
 Dietary Supplement: Chronic consumption of matching placebo
0mg chili pepper extract (matching placebo) per day in two divided doses (before the morning meal and before the evening meal) up to 12 weeks.

  Eligibility

Ages Eligible for Study:   25 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Is overweight or obese but otherwise generally healthy who interested in losing weight
  • BMI of 25 to 35 kg/m2
  • Waist/hip ratio of 0.9 or more for male and 0.85 for female.

Exclusion Criteria:

  • Type 1 or 2 diabetes mellitus
  • cardiovascular disease (other than mild, controlled hypertension or dislidemia)
  • On a weight-loss program within six months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00825838

Sponsors and Collaborators
Ajinomoto USA, INC.
Investigators
Study Chair: Soren Snitker, M.D., Ph.D. University of Maryland
Study Director: Yoshiyuki Fujishima, D. Phil. Ajinomoto USA, INC.
  More Information

No publications provided

Responsible Party: Kentaro Maruyama, Ajinomoto USA, Inc.
ClinicalTrials.gov Identifier: NCT00825838     History of Changes
Other Study ID Numbers: CH19-001
Study First Received: January 18, 2009
Last Updated: January 20, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Ajinomoto USA, INC.:
Body weight
Body composition
Resting metabolic rate and fat oxidation in men
class I obese

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
 Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013