Benefit and Tolerability of IQP-LU-104 in Weight Loss

This is an interventional treatment trial for Overweight focused on measuring Flaxseed mucilage, Weight loss, Satiety Read More

Inclusion Criteria:

1. Age 18 to 65 years
2. Overweight (BMI 25 to < 30 kg/m2) and moderately obese (BMI 30 to < 35 kg/m2) subjects
3. Generally in good health
4. Desire to lose weight
5. Accustomed to regular daily consumption of 3 main meals (breakfast, lunch, dinner)
6. Consistent and stable body weight in the last 3 months prior to V1 (less than 5% self-reported change)

7. Subject's agreement to comply with study procedures, in particular:

   • to take IP as recommended
   • to follow diet recommendation during the study
   • to complete the subject diary and study questionnaires
   • to maintain the habitual level of physical activity during the study

8. Women of childbearing potential:

   • commitment to use contraception methods
   • negative pregnancy testing (beta human chorionic gonadotropin test in urine) at V1
9. Consents to participate, understands requirements of the study and is willing to comply

Exclusion Criteria:

1. Known sensitivity to the ingredients of the investigational product or source of ingredients

2. History and/or presence of clinically significant condition/disorder, which per investigator's judgment could interfere with the results of the study or the safety of the subject, e.g.:

   • untreated or non-stabilised thyroid gland disorder
   • untreated or non-stabilised hypertension (regular systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg)
   • acute or chronic gastrointestinal (GI) disease or digestion/absorption disorders (e.g. inflammatory bowel disease, coeliac disease, pancreatitis etc.)
   • diabetes mellitus type 1
   • untreated or non-stabilised diabetes mellitus type 2
   • any other relevant serious organ or systemic diseases

3. Significant surgery within the last 6 months prior to V1:

   • GI surgery
   • liposuction
4. History of eating disorders like bulimia, anorexia nervosa, binge-eating within the last 12 months prior to V1

5. Deviation of safety laboratory parameter(s) at V1 that is:

   • 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)
6. Any electronic medical implant

7. Regular medication and/or supplementation and/or treatment within the last month prior to V1 and during the study, which per investigator's judgment could interfere with the results of the study or the safety of the subject, e.g.:

   • that could influence body weight (e.g. systemic cortcosteroids, antipsychotics, anti-depressants)
   • that could influence gastrointestinal functions (e.g. antibiotics, laxatives, opioids, anticholinergics etc.) as per investigator judgment
   • for weight management (e.g. fat binder, carbohydrate/starch blocker, fat burner, satiety products etc.)
   • any other relevant medication and/or supplementation
8. Diet/weight loss programs within the last 3 months prior to V1 and during the study
9. 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)
10. Vegetarian, vegan or other restrictive diet
11. Women of child-bearing potential: pregnancy or nursing
12. History of or current abuse of drugs, alcohol or medication
13. Participation in another clinical study in the 30 days prior to V1 and during the study
14. Any other reason for exclusion as per investigator's judgment