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

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: NCT00825838
Recruitment Status : Completed
First Posted : January 21, 2009
Last Update Posted : January 21, 2009
Sponsor:
Information provided by:
Ajinomoto USA, INC.

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

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
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
Study Start Date : April 2006
Actual Primary Completion Date : October 2006
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arms and Interventions
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Arm Intervention/treatment
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.


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

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

Eligibility Criteria
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Information from the National Library of Medicine

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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
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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
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Study Chair: Soren Snitker, M.D., Ph.D. University of Maryland School of Medicine
Study Director: Yoshiyuki Fujishima, D. Phil. Ajinomoto USA, INC.
More Information
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Responsible Party: Kentaro Maruyama, Ajinomoto USA, Inc.
ClinicalTrials.gov Identifier: NCT00825838    
Other Study ID Numbers: CH19-001
First Posted: January 21, 2009    Key Record Dates
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:
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Overweight
Overnutrition
Nutrition Disorders
Body Weight