Efficacy and Safety of Glucosanol in Maintaining Body Weight

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01435278
• Other study ID #: INQ/017011
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2011
• Last updated: July 25, 2012
• Start date: September 2011
• Est. completion date: July 2012

Study information

• Verified date: July 2012
• 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: July 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Body Weight
• Obesity
• Overweight

Intervention

Device:
• Glucosanol
2 tablets taken 3 times a day.

Locations

Country	Name	City	State
Germany	Barbara Grube, MD	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
InQpharm Group

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight	Measured in kg using a calibrated scale	24 weeks	No
Secondary	Waist and hip circumference (cm)	Changes from baseline to end of study	24 weeks	No
Secondary	Body mass index, BMI (kg/m2)	Changes from baseline to end of study	24 weeks	No
Secondary	Body fat content and fat free mass	Changes from baseline to end of study	24 weeks	No
Secondary	Effect on appetite, hunger and food cravings	The Control of Eating Questionnaire (COEQ) is used	24 weeks	No
Secondary	Feeling of satiety	A 4-point categorical scale is used	24 weeks	No
Secondary	Evaluation of the efficacy of Glucosanol by the subjects	A 4-point categorical scale is used	24 weeks	No
Secondary	Full blood count	Done at baseline and end of study	24 weeks	Yes
Secondary	Clinical chemistry parameter	Done at baseline and end of study	24 weeks	Yes
Secondary	Blood pressure	Measured in mm Hg	24 weeks	Yes
Secondary	Global evaluation of the safety of Glucosanol by the subjects	A 4-point categorical scale is used.	24 weeks	Yes
Secondary	Global evaluation of the safety of Glucosanol by the investigators	A 4-point categorical scale is used	24 weeks	Yes
Secondary	Occurrence of adverse events	All reported adverse events, regardless of causality, will be recorded in the source documents and case report forms	24 weeks	Yes