Clinical Trial: LEAN Project: Weight Loss and Appetite Suppression

This study is currently recruiting patients.
Verified by The Cooper Institute September 2005

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

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 Loss and Dieting

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: 
Primary Outcomes: Weight Loss; Appetite Suppression
Expected Total Enrollment:  60

Study start: April 2005;  Expected completion: May 2006
Last follow-up: May 2006;  Data entry closure: May 2006

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 caffiene 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 clincial measures.

Eligibility

Ages Eligible for Study:  30 Years   -   45 Years,  Genders Eligible for Study:  Female

Accepts Healthy Volunteers

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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00153790

Jo Talley      972 341 3281    jtalley@cooperinst.org

Texas
      The Cooper Institute, Dallas,  Texas,  75230,  United States; Recruiting
Jo Talley  972-341-3281    jtalley@cooperinst.org 
Conrad Earnest, PhD,  Principal Investigator

Study chairs or principal investigators

Conrad Earnest, PhD,  Principal Investigator,  The Cooper Institute   

More Information

Study ID Numbers:  CI0151
Last Updated:  September 9, 2005
Record first received:  September 7, 2005
ClinicalTrials.gov Identifier:  NCT00153790
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-13



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