NCT00825838

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2006

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 18, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 21, 2009

Completed
Last Updated

January 21, 2009

Status Verified

January 1, 2009

Enrollment Period

6 months

First QC Date

January 18, 2009

Last Update Submit

January 20, 2009

Conditions

OverweightObesity

Keywords

Body weightBody compositionResting metabolic rate and fat oxidation in menclass I obese

Outcome Measures

Primary Outcomes (1)

  • body weight and body composition

    12 weeks

Secondary Outcomes (1)

  • resting metabolic rate and substrate oxidation

    12 weeks

Study Arms (2)

1

EXPERIMENTAL

Oral ingestion of 6mg chili pepper extract

Dietary Supplement: Chronic consumption of chili pepper extract

2

PLACEBO COMPARATOR

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

Dietary Supplement: Chronic consumption of matching placebo

Interventions

Chronic consumption of chili pepper extractDIETARY_SUPPLEMENT

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

1
Chronic consumption of matching placeboDIETARY_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.

2

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Type 1 or 2 diabetes mellitus
  • cardiovascular disease (other than mild, controlled hypertension or dislidemia)
  • On a weight-loss program within six months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

OverweightObesityBody Weight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Soren Snitker, M.D., Ph.D.

    University of Maryland, Baltimore

    STUDY CHAIR

  • Yoshiyuki Fujishima, D. Phil.

    Ajinomoto USA, INC.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 18, 2009

First Posted

January 21, 2009

Study Start

April 1, 2006

Primary Completion

October 1, 2006

Study Completion

March 1, 2007

Last Updated

January 21, 2009

Record last verified: 2009-01