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Clinical Trial: LEAN Project: Weight Loss and Appetite Suppression
This study is currently recruiting patients.
Verified by The Cooper Institute September 2005
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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
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
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
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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