Safety and Efficacy of Glucosanol in Reducing Body Weight in Overweight and Obese Subjects

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.

Study Overview

• Status: Completed
• Conditions: Overweight and Obesity
• Intervention / Treatment: Device: Glucosanol; Device: Placebo

Detailed Description

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
• Enrollment (Actual): 124
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10709
    • Barbara Grube

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18 to 60 years
• BMI between 25 and 35
• Expressed desire for weight loss
• Accustomed to 3 main meals/day
• Consistent and stable body weight 3 months prior to study enrolment
• Commitment to avoid the use of other weight loss products during study
• Commitment to adhere to diet recommendation
• Females' agreement to use appropriate birth control methods during the active study period
• Subject declares in writing his/her consent to participate, understands requirements of the study and is willing to comply

Exclusion Criteria:

• Known sensitivity to the ingredients of the device
• History of Diabetes mellitus
• Fasting blood glucose >7 mmol/L
• History or clinical signs of endocrine disorders which may influence body weight (e.g., Cushing's disease, thyroid gland disorders)
• Clinically relevant excursions of safety parameter
• Current use of anti-depressants
• Presence of acute or chronic gastrointestinal disease (e.g., IBD, coeliac disease. pancreatitis)
• Uncontrolled hypertension (>160/110 mm Hg)
• Stenosis in the GI tract
• Bariatric surgery
• Abdominal surgery within the last 6 months prior to enrollment
• History of eating disorders such as bulimia, anorexia nervosa within the past 12 months
• Other serious organ or systemic diseases such as cancer
• Any medication that could influence GI functions such as antibiotics, laxatives, opioids, glucocorticoids, anticholinergics, or antidiarrheals (e.g., loperamide; must have stopped 1 months before study start)
• Pregnancy or nursing
• Any medication or use of products for the treatment of obesity
• More than 3 hours strenuous sport activity per week
• History of abuse of drugs, alcohol or medication
• Smoking cessation within 6 months prior to enrolment
• Inability to comply due to language difficulties
• Participation in similar studies or weight loss programs within 3 months prior to enrolment
• Participation in other studies within 4 weeks prior to enrollment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Device: Placebo; 2 tablets 3x daily for 12 weeks
Experimental: Glucosanol	Device: Glucosanol; 2 tablets 3x daily for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 weeks
waist circumference	Changes in waist circumference	12 weeks
hip circumference	Changes in hip circumference	12 weeks
waist-hip-ratio	Changes in waist-hip-ratio	12 weeks
BMI	Changes in BMI	12 weeks
body fat	Changes in body fat (% and kg) and fat free mass (kg)	12 weeks
hunger	Changes in hunger, eating, and food craving-related items from a Control of Eating Questionnaire	12 weeks
Global evaluation of feeling of satiety	This parameter will be assessed by a 4 points categorical scale	12 weeks
Global evaluation of the efficacy	This parameter will be assessed by a 4 points categorical scale	12 weeks
Global evaluation of safety	This will be assessed by both investigators and subjects by a 4 points categorical scale.	12 weeks

Collaborators and Investigators

• Sponsor: InQpharm Group
• Investigators: Principal Investigator: Barbara Grube, MD

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: June 30, 2011
• First Submitted That Met QC Criteria: August 1, 2011
• First Posted (Estimate): August 2, 2011

Study Record Updates

• Last Update Posted (Estimate): October 8, 2013
• Last Update Submitted That Met QC Criteria: October 7, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: obesity; overweight; appetite; weight loss; satiety; body fat; waste cirumference
• Additional Relevant MeSH Terms: Overweight; Body Weight
• Other Study ID Numbers: INQ/K/003411