LEAN Project: Weight Loss and Appetite Suppression

NCT ID: NCT00153790

Last Updated: 2014-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2006-05-31

Brief Summary

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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

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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.

Conditions

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Weight Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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PhosphoLean

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Chemi Nutra

UNKNOWN

Sponsor Role collaborator

The Cooper Institute

OTHER

Sponsor Role lead

Principal Investigators

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Conrad Earnest, PhD

Role: PRINCIPAL_INVESTIGATOR

The Cooper Institute

Locations

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The Cooper Institute

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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CI0151

Identifier Type: -

Identifier Source: org_study_id

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