Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
InQpharm Group
Age
18–60
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Efficacy and Safety of Glucosanol in Maintaining Body Weight
