DBRPC Study to Evaluate the Efficacy and Safety of IQP-AE-103 in Overweight and Moderately Obese Subjects

Inclusion Criteria

• •1. Men and women from 18 to 70 years old
• •2. Body mass index (BMI) 25 kg/m2 - 34.9 kg/m2
• •3. Having at least one of the following traits:
• •* waist circumference ≥ 94 cm in men and ≥ 80 cm in women
• •* triglyceride levels ≥ 150 mg/dL (1.7 mmol/L)
• •* high-density lipoprotein cholesterol (HDL-C) levels: ≤ 40 mg/dL (1.0 mmol/L) in men and ≤ 50 mg/dL (1.3 mmol/L) in women
• •* blood pressure (BP), average value of the last two values of the triplicate measurement: systolic BP ≥ 130 mmHg, diastolic BP ≥ 85 mmHg
• •* fasting blood glucose ≥ 100 mg/dL
• •4. Desire to lose weight
• •5. Readiness and ability to complete the study, according to investigator's judgement following the screening interview
• •6. Accustomed to regular daily consumption of 3 main meals (breakfast, lunch, dinner)
• •7. Consistent and stable body weight in the last 3 months prior to V1 (less than 5% self-reported change)
• •8. Subject's agreement to comply with study procedures, in particular:
• •* to adhere to diet recommendation during the study
• •* to take IP as recommended
• •* to avoid the use of other weight loss and/or management products and/or programs during the study
• •* to keep the habitual level of physical activity
• •* to complete the subject diary and study questionnaires
• •9. Women of childbearing potential:
• •* commitment to use contraception methods
• •* negative pregnancy testing (beta human chorionic gonadotropin test in urine) at V1
• •10. Readiness not to participate in another clinical study during this study Participation is based upon written informed consent by the participant following written and oral information by the investigator regarding nature, purpose, consequences and possible risks of the clinical study.
• •* clinically significant or
• •* \>2x upper limit of normal, unless the deviation is justified by a previously known not clinically relevant condition (e.g. Gilbert's syndrome)
• •7. Any electronic medical implant
• •8. 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. laxatives, opioids, anticholinergics etc.) as per investigator judgement
• •* for weight management (e.g. fat binder, carbohydrate/ starch blocker, fat burner, satiety products, acupuncture etc.)
• •* that could influence lipid levels, blood pressure and/or glycemic control
• •9. Self-reported smoking cessation within 6 months prior to V1 and/or during the study (regular smoking during the study at the same level as prior to the study is allowed)
• •10. Women of child-bearing potential: pregnancy or nursing
• •11. History of or current abuse of drugs, alcohol or medication
• •12. Participation in another study during the last 30 days prior to V1
• •13. Any other reason for exclusion as per investigator's judgment, e.g. insufficient compliance with study procedures