Efficacy and Safety of Glucosanol in Maintaining Body Weight

Open-label Clinical Investigation to Evaluate the Safety and Efficacy of Glucosanol in Maintaining Body Weight Loss in Overweight and Obese Subjects

To date, there is no clinical evidence on the efficacy and safety of Glucosanol in maintaining weight loss beyond the study duration of 12 weeks. The rationale for this open-label study is to assess the efficacy in preventing regain of loss body weight and safety of Glucosanol in subjects who are overweight or obese over a longer period after the initial weight loss.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • Barbara Grube, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Previously enrolled in, complied with, and completed the INQ/K/003411 (Glucosanol weight loss) study, with weight loss of at least 3% of baseline body weight
• Age 18 to 60 years at the time of inclusion into the INQ/K/003411 study
• BMI between 25-35 at the time of inclusion into the INQ/K/003411 study
• Expressed desire for weight maintenance
• Accustomed to 3 main meals per day
• Commitment to avoid the use of other weight loss products during study
• 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 (Phaseolus vulgaris or members of the Fabaceae family)
• History of diabetes mellitus • Fasting blood glucose more than 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 (more than 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 like 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 anti-diarrheals
• Pregnancy or nursing
• Any medication or use of products for the treatment of obesity (e.g. Orlistat, other fatbinder, carb/starch blocker, fatburner, satiety products etc.)
• 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
• Presence of other factor(s) that, in the investigator's judgement, should preclude subject participation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Glucosanol; 2 tablets 3 times a day	Device: Glucosanol; 2 tablets taken 3 times a day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight	Measured in kg using a calibrated scale	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Waist and hip circumference (cm)	Changes from baseline to end of study	24 weeks
Body mass index, BMI (kg/m2)	Changes from baseline to end of study	24 weeks
Body fat content and fat free mass	Changes from baseline to end of study	24 weeks
Effect on appetite, hunger and food cravings	The Control of Eating Questionnaire (COEQ) is used	24 weeks
Feeling of satiety	A 4-point categorical scale is used	24 weeks
Evaluation of the efficacy of Glucosanol by the subjects	A 4-point categorical scale is used	24 weeks
Full blood count	Done at baseline and end of study	24 weeks
Clinical chemistry parameter	Done at baseline and end of study	24 weeks
Blood pressure	Measured in mm Hg	24 weeks
Global evaluation of the safety of Glucosanol by the subjects	A 4-point categorical scale is used.	24 weeks
Global evaluation of the safety of Glucosanol by the investigators	A 4-point categorical scale is used	24 weeks
Occurrence of adverse events	All reported adverse events, regardless of causality, will be recorded in the source documents and case report forms	24 weeks

Collaborators and Investigators

• Sponsor: InQpharm Group

Publications and helpful links

General Publications

• Grube B, Chong WF, Chong PW, Riede L. Weight reduction and maintenance with IQP-PV-101: a 12-week randomized controlled study with a 24-week open label period. Obesity (Silver Spring). 2014 Mar;22(3):645-51. doi: 10.1002/oby.20577. Epub 2013 Sep 5. Erratum In: Obesity (Silver Spring). 2014 Oct;22(10):2274-5.

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: September 13, 2011
• First Submitted That Met QC Criteria: September 15, 2011
• First Posted (Estimate): September 16, 2011

Study Record Updates

• Last Update Posted (Estimate): July 27, 2012
• Last Update Submitted That Met QC Criteria: July 25, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: Obesity; Overweight; Satiety; BMI; Body weight; Weight maintenance
• Additional Relevant MeSH Terms: Overweight; Body Weight
• Other Study ID Numbers: INQ/017011