LEAN Project: Weight Loss and Appetite Suppression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00153790
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : March 13, 2014
Chemi Nutra
Information provided by:
The Cooper Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Weight Loss Drug: PhosphoLean Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : April 2005
Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Weight Loss
  2. Appetite Suppression

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00153790

United States, Texas
The Cooper Institute
Dallas, Texas, United States, 75230
Sponsors and Collaborators
The Cooper Institute
Chemi Nutra
Principal Investigator: Conrad Earnest, PhD The Cooper Institute Identifier: NCT00153790     History of Changes
Other Study ID Numbers: CI0151
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: March 13, 2014
Last Verified: March 2014

Keywords provided by The Cooper Institute:
green tea

Additional relevant MeSH terms:
Body Weight
Weight Loss
Signs and Symptoms
Body Weight Changes
Epigallocatechin gallate
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antimutagenic Agents
Anticarcinogenic Agents
Antineoplastic Agents
Neuroprotective Agents