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.