LEAN Project: Weight Loss and Appetite Suppression - Full Text View

Purpose

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.

Condition	Intervention	Phase
Weight Loss	Drug: PhosphoLean	Phase I

MedlinePlus related topics:

Weight Control

ChemIDplus related topics:

Epigallocatechin gallate Proteins, soy Lecithin Ethanolamine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study

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

Further study details as provided by The Cooper Institute:

Primary Outcome Measures:

Weight Loss
Appetite Suppression

Estimated Enrollment:	60
Study Start Date:	April 2005
Estimated Study Completion Date:	May 2006

Detailed 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.

Eligibility

Ages Eligible for Study:	30 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00153790

Locations


United States, Texas
	The Cooper Institute
	Dallas, Texas, United States, 75230

Sponsors and Collaborators

The Cooper Institute

Chemi Nutra

Investigators


Principal Investigator:	Conrad Earnest, PhD	The Cooper Institute

More Information

Study ID Numbers:	CI0151
First Received:	September 7, 2005
Last Updated:	March 30, 2006
ClinicalTrials.gov Identifier:	NCT00153790
Health Authority:	United States: Institutional Review Board

Keywords provided by The Cooper Institute:

green tea

weight

women

Study placed in the following topic categories:

Body Weight

Epigallocatechin gallate

Signs and Symptoms

Weight Loss

Body Weight Changes

ClinicalTrials.gov processed this record on October 07, 2008

Sponsors and Collaborators:	The Cooper Institute Chemi Nutra
Information provided by:	The Cooper Institute
ClinicalTrials.gov Identifier:	NCT00153790