| Weight
Loss |
| Outline: |
Double-Blind
Efficacy Evaluation of a Test Material in the Reduction of Body Weight
and Body Mass |
| Objective: |
To
determine the efficacy of a product for reducing body weight and body
mass |
| Subjects: |
60
Qualified Individuals (BMI of 27 and over) |
| Timing: |
6
week study
Start within 2 weeks from receipt of materials
Draft report within 4 weeks of completion |
| Quantity: |
Enough
product to last for 6 weeks of treatment |
| Methodology: |
Body
Weight
Body Mass Index (BMI) |
|
Procedure:
|
Subjects
are screened over the telephone and qualified on Day 1 of the study.
A registered nurse takes and records vital signs, weight, and BMI.
Qualified subjects are assigned into 1 of 2 product groups, dispensed
product and given instructions for use and a daily diary. Vital sings,
weight and BMI measurements are taken again after 1, 3 and 6 weeks
of product usage.
Results
are statistically analyzed to determine any differences from baseline
and between the two treatment groups.
|