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

NCT ID: NCT00825838

Last Updated: 2009-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2007-03-31

Brief Summary

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

Detailed Description

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Conditions

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Overweight Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Oral ingestion of 6mg chili pepper extract

Group Type EXPERIMENTAL

Chronic consumption of chili pepper extract

Intervention Type DIETARY_SUPPLEMENT

6mg chili pepper extract per day in two divided doses (before the morning meal and before the evening meal) up to 12 weeks.

2

Oral ingestion of 0 mg chili pepper extract (matching placebo)

Group Type PLACEBO_COMPARATOR

Chronic consumption of matching placebo

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ajinomoto USA, INC.

INDUSTRY

Sponsor Role lead

Responsible Party

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Ajinomoto USA, Inc.

Principal Investigators

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Soren Snitker, M.D., Ph.D.

Role: STUDY_CHAIR

University of Maryland, Baltimore

Yoshiyuki Fujishima, D. Phil.

Role: STUDY_DIRECTOR

Ajinomoto USA, INC.

Other Identifiers

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CH19-001

Identifier Type: -

Identifier Source: org_study_id

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