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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01407393
• Other study ID #: INQ/K/003411
• Status: Completed
• Phase: Phase 4
• First received: June 30, 2011
• Last updated: October 7, 2013
• Start date: May 2011
• Est. completion date: December 2011

Study information

• Verified date: October 2013
• Source: InQpharm Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Body Weight
• Overweight
• Overweight and Obesity

Intervention

Device:
• Glucosanol
2 tablets 3x daily for 12 weeks
• Placebo
2 tablets 3x daily for 12 weeks

Locations

Country	Name	City	State
Germany	Barbara Grube	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
InQpharm Group

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	waist circumference	Changes in waist circumference	12 weeks	No
Secondary	hip circumference	Changes in hip circumference	12 weeks	No
Secondary	waist-hip-ratio	Changes in waist-hip-ratio	12 weeks	No
Secondary	BMI	Changes in BMI	12 weeks	No
Secondary	body fat	Changes in body fat (% and kg) and fat free mass (kg)	12 weeks	No
Secondary	hunger	Changes in hunger, eating, and food craving-related items from a Control of Eating Questionnaire	12 weeks	No
Secondary	Global evaluation of feeling of satiety	This parameter will be assessed by a 4 points categorical scale	12 weeks	No
Secondary	Global evaluation of the efficacy	This parameter will be assessed by a 4 points categorical scale	12 weeks	No
Secondary	Global evaluation of safety	This will be assessed by both investigators and subjects by a 4 points categorical scale.	12 weeks	Yes