Benefit and Tolerability of IQP-AE-103 in Weight Loss

Inclusion criteria

• Age 18 to 65 years
• Overweight to moderately obese subjects (BMI ≥ 25 and < 35 kg/m2)
• Expressed desire for weight loss
• Accustomed to 3 main meals/day
• Commitment to take IP as recommended
• Commitment to adhere to diet recommendation during the study
• Commitment to maintain habitual level of activity/exercise during the study
• Consistent and stable body weight for 3 months prior to V1
• Commitment to avoid the use of other weight management products or programs during study
• Commitment and ability to complete the subject diary and study questionnaires
• Females of childbearing potential: negative pregnancy testing (beta HCG-test in urine) at V1, agreement to use appropriate contraception methods during the study period
• Consents to participate, understands requirements of the study and is willing to comply

Exclusion criteria

• Known sensitivity to the ingredients of the investigational product or source of ingredients
• Pregnancy or nursing
• 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)
• Current or history of abuse of drugs, alcohol or medication
• Clinically relevant excursions of safety laboratory parameter
• Diabetes mellitus type 1
• Untreated or unstable diabetes mellitus type 2
• Untreated or unstable endocrine disorders which may influence body weight (e.g. Cushing's disease, thyroid gland disorders)
• Stenosis in the gastrointestinal (GI) tract
• Bariatric surgery in subject´s medical history
• Abdominal surgery within the last 6 months prior to V1
• Current use of medications that may affect body weight (eg. antipsychotics, anti-depressants, corticosteroids etc.)
• Presence of acute or chronic gastrointestinal disease (e.g. inflammatory bowel disease, coeliac disease, pancreatitis)
• Digestion/absorption disorders in gastrointestinal (GI) tract
• History of eating disorders such as bulimia, anorexia nervosa within the past 12 months prior to V1
• Other serious organ or systemic diseases such as cancer within the last 5 years prior to V1
• Any electronic medical implant
• Use of any medication that could influence GI functions such as antibiotics within 4 weeks and any laxatives, opioids, glucocorticoids, anticholinergics within last 3 months prior to V1 and during the study, as per investigator judgement
• Any medication or use of products for the treatment of obesity (e.g. orlistat, other fat binder, carbohydrate/starch blocker, fat burner, satiety products etc.) within last 3 months prior to V1 and during the study
• Participation in similar studies or weight loss programs within last 4 weeks prior to V1
• Participation in other studies during the last 4 weeks prior to V1
• Inability to comply
• Presence of other factor(s) or medication that should preclude subject participation as per investigator judgement