Back to resultsLEAN Project: Weight Loss and Appetite Suppression
Primary Purpose
Weight Loss
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PhosphoLean
Sponsored by
About this trial
This is an interventional treatment trial for Weight Loss focused on measuring green tea, weight, women
Eligibility 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
Sites / Locations
- The Cooper Institute
Outcomes
Primary Outcome Measures
Weight Loss
Appetite Suppression
Secondary Outcome Measures
Full Information
NCT ID
NCT00153790
First Posted
September 7, 2005
Last Updated
March 12, 2014
Sponsor
The Cooper Institute
Collaborators
Chemi Nutra
1. Study Identification
Unique Protocol Identification Number
NCT00153790
Brief Title
LEAN Project: Weight Loss and Appetite Suppression
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 Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
The Cooper Institute
Collaborators
Chemi Nutra
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss
Keywords
green tea, weight, women
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
PhosphoLean
Primary Outcome Measure Information:
Title
Weight Loss
Title
Appetite Suppression
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Conrad Earnest, PhD
Organizational Affiliation
The Cooper Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Cooper Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
12. IPD Sharing Statement
Learn more about this trial
LEAN Project: Weight Loss and Appetite Suppression
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