Body Weight Clinical Trial
Official title:
A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Effects of a Weight Management Program on Body Weight in Individuals Who Are Overweight and Otherwise Healthy
The purpose of the study is to assess the safety and effectiveness of the Weight Management Program on body weight
This is a double-blind, randomized, placebo-controlled study to evaluate the effects of a
Weight Management program on body weight. Each subject will receive a specific dose of the
study product (A) to be taken twice daily with breakfast and dinner and a specific dose of
the study product (B) to be taken 15 minutes before lunch daily for a total of 60 days. Each
subject based upon the randomization will also receive a handout with suggestions for healthy
eating and overall health.
Participants receive questionnaires, assessments, blood tests, vital signs and a body
composition analysis.
The primary objective is the assessment of the change in body weight in response to the
Weight Management program relative to baseline compared with placebo
The secondary objective is the assessment of the change in waist circumference, parameters
from the body composition analysis, appetite, the levels of blood lipids and C-reactive
protein in response to the Weight Management program relative to baseline compared with
placebo
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