- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00825838
Effect of Chili Pepper Extract on Weight and Fat Loss and Metabolism Increase
January 20, 2009 updated by: Ajinomoto USA, INC.
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
The purpose of this study is to test the safety and effectiveness of a purified extract of CH-19 Sweet, containing capsinoids.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
23 years to 58 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Oral ingestion of 6mg 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)
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
body weight and body composition
Time Frame: 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
resting metabolic rate and substrate oxidation
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Soren Snitker, M.D., Ph.D., University of Maryland School of Medicine
- Study Director: Yoshiyuki Fujishima, D. Phil., Ajinomoto USA, INC.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2006
Primary Completion (Actual)
October 1, 2006
Study Completion (Actual)
March 1, 2007
Study Registration Dates
First Submitted
January 18, 2009
First Submitted That Met QC Criteria
January 20, 2009
First Posted (Estimate)
January 21, 2009
Study Record Updates
Last Update Posted (Estimate)
January 21, 2009
Last Update Submitted That Met QC Criteria
January 20, 2009
Last Verified
January 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CH19-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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