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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
124
2 tablets 3x daily for 12 weeks
2 tablets 3x daily for 12 weeks
Barbara Grube
Berlin, Germany
weight loss
The primary endpoint of this randomized, double-blind, placebo-controlled bicen-tric study is to assess the weight loss effect of Glucosanol™ (kg), in combination with a weight loss program in overweight and obese subjects.
Time frame: 12 weeks
Proportion body weight
To assess the efficacy of Glucosanol™ to increase the proportions of subjects who lose at least 3% and 5% of baseline body weight
Time frame: 12 weeks
waist circumference
Changes in waist circumference
Time frame: 12 weeks
hip circumference
Changes in hip circumference
Time frame: 12 weeks
waist-hip-ratio
Changes in waist-hip-ratio
Time frame: 12 weeks
BMI
Changes in BMI
Time frame: 12 weeks
body fat
Changes in body fat (% and kg) and fat free mass (kg)
Time frame: 12 weeks
hunger
Changes in hunger, eating, and food craving-related items from a Control of Eating Questionnaire
Time frame: 12 weeks
Global evaluation of feeling of satiety
This parameter will be assessed by a 4 points categorical scale
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Time frame: 12 weeks
Global evaluation of the efficacy
This parameter will be assessed by a 4 points categorical scale
Time frame: 12 weeks
Global evaluation of safety
This will be assessed by both investigators and subjects by a 4 points categorical scale.
Time frame: 12 weeks