Clinical trial NCT01435278: Efficacy and Safety of Glucosanol in Maintaining Body Weight
Official title: Open-label Clinical Investigation to Evaluate the Safety and Efficacy of Glucosanol in Maintaining Body Weight Loss in Overweight and Obese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Overweight
Obesity
Keywords: Weight maintenance
BMI
Body weight
Overweight
Obesity
Satiety
Lead sponsor: InQpharm Group
Sponsor class: INDUSTRY
First posted: 2011-09-16
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Body weight
timeFrame: 24 weeks
Secondary outcomes:
measure: Waist and hip circumference (cm)
timeFrame: 24 weeks
measure: Body mass index, BMI (kg/m2)
timeFrame: 24 weeks
measure: Body fat content and fat free mass
timeFrame: 24 weeks
measure: Effect on appetite, hunger and food cravings
timeFrame: 24 weeks
measure: Feeling of satiety
timeFrame: 24 weeks
measure: Evaluation of the efficacy of Glucosanol by the subjects
timeFrame: 24 weeks
measure: Full blood count
timeFrame: 24 weeks
measure: Clinical chemistry parameter
timeFrame: 24 weeks
measure: Blood pressure
timeFrame: 24 weeks
measure: Global evaluation of the safety of Glucosanol by the subjects
timeFrame: 24 weeks
measure: Global evaluation of the safety of Glucosanol by the investigators
timeFrame: 24 weeks
measure: Occurrence of adverse events
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Barbara Grube, MD
Study officials:
References:
citation: 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.