Obesity, Overweight
Conditions
Brief summary
This study is to evaluate the benefit and tolerability of two dosages of IQP-AE-103 (990mg and 1980mg daily) in reducing body weight in overweight and moderately obese subjects
Interventions
DIETARY_SUPPLEMENTIQP-AE-103 (330mg)
High dose capsules
DIETARY_SUPPLEMENTIQP-AE-103 (165mg)
Low dose capsules
DIETARY_SUPPLEMENTPlacebo
Placebo identical to verum capsules
Sponsors
InQpharm Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age 18 to 65 years 2. Overweight to moderately obese subjects (BMI ≥ 25 and \< 35 kg/m2) 3. Expressed desire for weight loss 4. Accustomed to 3 main meals/day 5. Commitment to take IP as recommended 6. Commitment to adhere to diet recommendation during the study 7. Commitment to maintain habitual level of activity/exercise during the study 8. Consistent and stable body weight for 3 months prior to V1 9. Commitment to avoid the use of other weight management products or programs during study 10. Commitment and ability to complete the subject diary and study questionnaires 11. Females of childbearing potential: negative pregnancy testing (beta HCG-test in urine) at V1, agreement to use appropriate contraception methods during the study period 12. 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. Pregnancy or nursing 3. 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) 4. Current or history of abuse of drugs, alcohol or medication 5. Clinically relevant excursions of safety laboratory parameter 6. Diabetes mellitus type 1 7. Untreated or unstable diabetes mellitus type 2 8. Untreated or unstable endocrine disorders which may influence body weight (e.g. Cushing's disease, thyroid gland disorders) 9. Stenosis in the gastrointestinal (GI) tract 10. Bariatric surgery in subject´s medical history 11. Abdominal surgery within the last 6 months prior to V1 12. Current use of medications that may affect body weight (eg. antipsychotics, anti-depressants, corticosteroids etc.) 13. Presence of acute or chronic gastrointestinal disease (e.g. inflammatory bowel disease, coeliac disease, pancreatitis) 14. Digestion/absorption disorders in gastrointestinal (GI) tract 15. History of eating disorders such as bulimia, anorexia nervosa within the past 12 months prior to V1 16. Other serious organ or systemic diseases such as cancer within the last 5 years prior to V1 17. Any electronic medical implant 18. 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 19. 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 20. Participation in similar studies or weight loss programs within last 4 weeks prior to V1 21. Participation in other studies during the last 4 weeks prior to V1 22. Inability to comply 23. Presence of other factor(s) or medication that should preclude subject participation as per investigator judgement
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in body weight (kg) | 12 weeks | Difference in mean change of body weight (kg) between the higher dosed verum (1980 mg a day) and placebo group after 12 weeks of intervention in comparison to baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in body weight (kg) | 2, 4, 8, 12 weeks | Changes in body weight (kg) after 2, 4, 8, and 12 weeks of intervention, each in comparison to baseline, between the two active and placebo group |
| Mean change in body weight (%) | 2, 4, 8, 12 weeks | Changes in body weight (%) after 2, 4, 8, and 12 weeks of intervention, each in comparison to baseline, between the two active and placebo group |
| Change in waist circumference (cm) | 2, 4, 8, 12 weeks | Changes in waist circumference after 2, 4, 8, and 12 weeks intervention, each in comparison to baseline |
| Change in hip circumference (cm) | 2, 4, 8, 12 weeks | Changes in hip circumference after 2, 4, 8, and 12 weeks intervention, each in comparison to baseline |
| Proportion of subject weight loss | 2, 4, 8, 12 weeks | Proportion of subjects who lost at least 3% and 5% of baseline body weight after 2, 4, 8, and 12 weeks intervention, each in comparison to baseline |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety parameters (lab parameters, vital signs) | 12 weeks | Change in safety lab parameters, vital signs |
Countries
Germany
Outcome results
None listed