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NCT00153790 Clinical Trial

LEAN Project: Weight Loss and Appetite Suppression

Weight Loss Clinical Trial

Official title:
The Effect of Soy Lecithin-derived N-oleoyl-phosphatidyl-ethanolamine (NOPE) and Green Tea-derived Epigallocatechin Gallate (EGCG) on Indices of Weight Loss and Appetite Suppression

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00153790
Other study ID # CI0151
Secondary ID
Status Completed
Phase Phase 1
First received September 7, 2005
Last updated March 12, 2014
Start date April 2005
Est. completion date May 2006

Study information
Verified date March 2014
Source The Cooper Institute
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The primary aim is to examine whether the intake of PhosphoLEAN is effective in aiding a cohort of women in losing weight. Participants taking the supplement will have significantly greater improvement in study outcomes than those taking the placebo.

Description:

Participants will be randomized to either a control or treatment group taking the dietary supplement containing a soy lecithin-derived N-oleoyl-phosphatidyl-ethanolamine (NOPE) and caffeine free Green Tea-derived epigallocathchin gallate (EGCG) whose trade name is PhosphoLean. The outcome is to determine the effects on indices of weight loss and appetite suppression. Participants will return at 6, 12, and 16 weeks for clinical measures.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date May 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 30 Years to 45 Years
Eligibility Inclusion Criteria:

- 30-45 years, women, overweight or obese class I, premenopausal, maintain current diet and exercise regimen

Exclusion Criteria:

- pregnant or planning to become pregnant, currently have or history of cancer, heart disease, anemia, diabetes, depression

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• PhosphoLean

Locations
Country Name City State
United States The Cooper Institute Dallas Texas

Sponsors (2)
Lead Sponsor Collaborator
The Cooper Institute Chemi Nutra

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Weight Loss
Primary Appetite Suppression
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