Obesity, Overweight
Conditions
Keywords
Weight maintenance, BMI, Body weight, Overweight, Obesity, Satiety
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.
Interventions
DEVICEGlucosanol
2 tablets taken 3 times a day.
Sponsors
InQpharm Group
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body weight | 24 weeks | Measured in kg using a calibrated scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Waist and hip circumference (cm) | 24 weeks | Changes from baseline to 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 |
| Full blood count | 24 weeks | Done at baseline and end of study |
Countries
Germany
Outcome results
None listed