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LEAN Project: Weight Loss and Appetite Suppression

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00153790
First Posted: September 12, 2005
Last Update Posted: March 13, 2014
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.
Collaborator:
Chemi Nutra
Information provided by:
The Cooper Institute
  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 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years to 45 Years   (Adult)
Sexes 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
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 ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00153790     History of Changes
Other Study ID Numbers: CI0151
First Submitted: September 7, 2005
First Posted: September 12, 2005
Last Update Posted: March 13, 2014
Last Verified: March 2014

Keywords provided by The Cooper Institute:
green tea
weight
women

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