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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00825838
• Other study ID #: CH19-001
• Status: Completed
• Phase: Phase 2
• First received: January 18, 2009
• Last updated: January 20, 2009
• Start date: April 2006
• Est. completion date: March 2007

Study information

• Verified date: January 2009
• Source: Ajinomoto USA, INC.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 2007
• Est. primary completion date: October 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ajinomoto USA, INC.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	body weight and body composition		12 weeks	No
Secondary	resting metabolic rate and substrate oxidation		12 weeks	No