Safety/Effacy Clinical Trial
Official title:
A Phase IV, Open-label, Parallel Group, Single-Center Study on the Effects of a Nutritional Supplement Combination on Body Weight Management Over a 90-day Period
Title: A Phase IV, Open-label, Single-Center Study on the Effects of a Nutritional Supplement Combination on Body Weight Management over a 90-day period
Safety assessment:
Safety will be assessed by changes in blood chemistries/hematology, and adverse events, of
nutritional supplement emergent AEs (TEAEs), classified by severity grade, relatedness to
the nutritional supplement.
Efficacy Assessment:
The objectives of this study are to evaluate the efficacy (changes in body composition and
measurements as well as influence on appetite and quality of life changes) of the
nutritional supplement administered repeatedly throughout the study.
Study Subject Population:
Healthy adult men and women are eligible for participation upon fulfillment of the
inclusion/exclusion criteria.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment