Overweight and Obesity Clinical Trial
Official title:
Double-blind, Randomized, Placebo-controlled, Bicentric Clinical Investigation to Evaluate Safety and Efficacy of Glucosanol in Reducing Body Weight in Overweight and Obese Subjects
Glucosanol™, the medical device to be investigated contains a proprietary plant extract that
is a natural inhibitor of alpha-amylase and can reduce starch digestion.
The rationale for this study is to confirm that Glucosanol™ ingestion will reduce body
weight. A double-blind, randomized, placebo-controlled design has been chosen to assess the
efficacy and safety of Glucosanol™ in subjects who are overweight and mildly obese.
Preparations that reduce absorption of calories from dietary carbohydrates could be
decisively meaningful for the regulation of bodyweight or obesity. Hence, Glucosanol™ may be
used as a tool for the treatment of obesity and weight management through reduced
carbohydrate absorption.
The rationale for this study is to confirm that Glucosanol™ ingestion will reduce body
weight. A double-blind, randomized, placebo-controlled design has been chosen to assess the
efficacy and safety of Glucosanol™ in subjects who are overweight and mildly obese.
The specific hypotheses to be accepted or rejected by statistical data from the clinical
investigation are beneficial effects of the device on weight loss (kg) and body fat content.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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