NCT00825838CompletedPhase 2
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
Ajinomoto USA, INC.0 sites80 target enrollmentStarted: April 1, 2006Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 80
- Primary Endpoint
- body weight and body composition
Study Overview
Brief Summary
The purpose of this study is to test the safety and effectiveness of a purified extract of CH-19 Sweet, containing capsinoids.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 25 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
body weight and body composition
Time Frame: 12 weeks
Secondary Outcomes
- resting metabolic rate and substrate oxidation(12 weeks)
Investigators
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