Efficacy Evaluation of a Test Material in the Reduction of Body Weight
and Body Mass
determine the efficacy of a product for reducing body weight and body
Qualified Individuals (BMI of 27 and over)
Start within 2 weeks from receipt of materials
Draft report within 4 weeks of completion
product to last for 6 weeks of treatment
Body Mass Index (BMI)
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.
are statistically analyzed to determine any differences from baseline
and between the two treatment groups.