Back to resultsEffect of Chili Pepper Extract on Weight and Fat Loss and Metabolism Increase
Primary Purpose
Overweight, Obesity
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Chronic consumption of chili pepper extract
Chronic consumption of matching placebo
Sponsored by
About this trial
This is an interventional treatment trial for Overweight focused on measuring Body weight, Body composition, Resting metabolic rate and fat oxidation in men, class I obese
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Oral ingestion of 6mg chili pepper extract
Oral ingestion of 0 mg chili pepper extract (matching placebo)
Outcomes
Primary Outcome Measures
body weight and body composition
Secondary Outcome Measures
resting metabolic rate and substrate oxidation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00825838
Brief Title
Effect of Chili Pepper Extract on Weight and Fat Loss and Metabolism Increase
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 Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Ajinomoto USA, INC.
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to test the safety and effectiveness of a purified extract of CH-19 Sweet, containing capsinoids.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
Body weight, Body composition, Resting metabolic rate and fat oxidation in men, class I obese
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Oral ingestion of 6mg chili pepper extract
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Oral ingestion of 0 mg chili pepper extract (matching placebo)
Intervention Type
Dietary Supplement
Intervention Name(s)
Chronic consumption of chili pepper extract
Intervention Description
6mg chili pepper extract per day in two divided doses (before the morning meal and before the evening meal) up to 12 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Chronic consumption of matching placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
body weight and body composition
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
resting metabolic rate and substrate oxidation
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Soren Snitker, M.D., Ph.D.
Organizational Affiliation
University of Maryland, Baltimore
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Yoshiyuki Fujishima, D. Phil.
Organizational Affiliation
Ajinomoto USA, INC.
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Effect of Chili Pepper Extract on Weight and Fat Loss and Metabolism Increase
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