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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00825838
First Posted: January 21, 2009
Last Update Posted: January 21, 2009
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.
Information provided by:
Ajinomoto USA, INC.
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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:


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

Primary Outcome Measures:
  • body weight and body composition [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • resting metabolic rate and substrate oxidation [ Time Frame: 12 weeks ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
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): 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

Responsible Party: Kentaro Maruyama, Ajinomoto USA, Inc.
ClinicalTrials.gov Identifier: NCT00825838     History of Changes
Other Study ID Numbers: CH19-001
First Submitted: January 18, 2009
First Posted: January 21, 2009
Last Update Posted: January 21, 2009
Last Verified: January 2009

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:
Overweight
Body Weight
Signs and Symptoms