Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
InQpharm Group
Age
18–65
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
BMI 25 kg/m2 - 34,9 kg/m2
Generally in good health• Desire to lose weight
Accustomed to regular daily consumption of 3 main meals (breakfast, lunch, dinner)
Consistent and stable body weight in the last 3 months prior to V1 (less than 5% self-reported change)• Readiness to take IP as recommended
Readiness to avoid the use of other weight loss and/or management products and/or programs during the study
Readiness to adhere to diet recommendation during the study
Readiness to keep the habitual level of physical activity as prior to the study during the study
Readiness and ability to complete the subject diary and study questionnaires
Negative pregnancy testing (beta HCG-test in urine) at V1 in women of childbearing potential
Women of childbearing potential: commitment to use contraception methods
You may not be if
Known allergy or hypersensitivity to the components of the investigational products
Known allergy or hypersensitivity to members of the Fabaceae family
Known food allergy (e.g. to cow's milk, eggs, wheat, crustacean, nuts etc.)
Significant disorders:
* untreated or unstable thyroid gland disorder
* untreated or unstable hypertension (\>140/90 mm Hg)
* acute or chronic gastrointestinal (GI) disease or malabsorption disorders (e.g. inflammatory bowel disease, coeliac disease, pancreatitis etc.)
* diabetes mellitus- coagulation disorder- any other serious organ or systemic diseases that could influence the conduct and/or out-come of the study and/or could affect the tolerability of the subject (in the opinion of the investigator)
Significant surgery within the last 6 months prior to V1:
* GI surgery
* liposuction
History of eating disorders like bulimia, anorexia nervosa, binge-eating within the last 12 monthsprior to V1
Clinically relevant excursions of safety laboratoryparameters
Any electronic medical implant
Regular use of anticoagulants
Regular medication and/or supplementation and/or treatment within the last 3 months prior to V1 and during the study:
* that could influence body weight (e.g. systemic corticosteroids)
* that could influence gastrointestinal functions (e.g. antibiotics, laxatives, opioids, glucocorticoids, anticholinergics, anti-diarrheals etc.) as per investigator judgement
Consumption of food supplements or natural health products for the duration of the study
Diet to lose and/or manage weight (except ac-cording to the study protocol)
Vegetarian, vegan or macrobiotic diet
Smoking cessation within 6 months prior to V1 or during the study (regular smoking during the study at the same level as prior to the study is allowed)
Pregnancy or nursing
History of or current abuse of drugs, alcohol or medication
Inability to comply with study requirements
Subjects who are deprived of their freedom by administrative or legal decision or who are in guardianship
Participation in another clinical study in the 30 days prior to V1 and during the study
