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LEAN Project: Weight Loss and Appetite Suppression

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Chemi Nutra
Information provided by:
The Cooper Institute
ClinicalTrials.gov Identifier:
NCT00153790
First received: September 7, 2005
Last updated: August 1, 2012
Last verified: August 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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:

MedlinePlus related topics: Weight Control
U.S. FDA Resources

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

No publications provided

ClinicalTrials.gov Identifier: NCT00153790     History of Changes
Other Study ID Numbers: CI0151
Study First Received: September 7, 2005
Last Updated: August 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by The Cooper Institute:
green tea
weight
women

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

ClinicalTrials.gov processed this record on May 22, 2013