Efficacy and Safety of Glucosanol in Maintaining Body Weight
- Conditions
- OverweightObesity
- Interventions
- Device: Glucosanol
- Registration Number
- NCT01435278
- Lead Sponsor
- InQpharm Group
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 51
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Glucosanol Glucosanol 2 tablets 3 times a day
- Primary Outcome Measures
Name Time Method Body weight 24 weeks Measured in kg using a calibrated scale
- Secondary Outcome Measures
Name Time Method Waist and hip circumference (cm) 24 weeks Changes from baseline to end of study
Body mass index, BMI (kg/m2) 24 weeks Changes from baseline to end of study
Body fat content and fat free mass 24 weeks Changes from baseline to end of study
Effect on appetite, hunger and food cravings 24 weeks The Control of Eating Questionnaire (COEQ) is used
Feeling of satiety 24 weeks A 4-point categorical scale is used
Evaluation of the efficacy of Glucosanol by the subjects 24 weeks A 4-point categorical scale is used
Full blood count 24 weeks Done at baseline and end of study
Clinical chemistry parameter 24 weeks Done at baseline and end of study
Blood pressure 24 weeks Measured in mm Hg
Global evaluation of the safety of Glucosanol by the subjects 24 weeks A 4-point categorical scale is used.
Global evaluation of the safety of Glucosanol by the investigators 24 weeks A 4-point categorical scale is used
Occurrence of adverse events 24 weeks All reported adverse events, regardless of causality, will be recorded in the source documents and case report forms
Trial Locations
- Locations (1)
Barbara Grube, MD
🇩🇪Berlin, Germany