Efficacy and Safety of Glucosanol in Maintaining Body Weight

InQpharm

Status and phase

Completed

Phase 4

Conditions

Overweight

Obesity

Treatments

Device: Glucosanol

Study type

Interventional

Funder types

Industry

Identifiers

NCT01435278

INQ/017011

Details and patient eligibility

About

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.

Enrollment

51 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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