Obesity; Excess Calories, Overweight and Obesity, Weight Loss
Conditions
Keywords
Litramine, Opuntia ficus-indica, weight loss
Brief summary
To evaluate the efficacy of Litramine in reducing body weight in the context of an energy-restricted diet in overweight and moderately obese subjects
Interventions
DIETARY_SUPPLEMENTLitramine
2 tablets to be taken 3 times a day after meals
DIETARY_SUPPLEMENTPlacebo tablet
2 tablets to be taken 3 times a day after meals
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 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Men and women from 18 to 70 years old 2. Overweight (BMI 25 kg/m2 - 29.9 kg/m2) for 80% of randomized subjects and obese (BMI 30 kg/m2 - 34.9 kg/m2) for 20% of randomized subjects 3. Generally in good health 4. Desire to lose weight 5. Readiness and ability to complete the 1-year 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 take IP as recommended * to avoid the use of other weight loss and/or management products and/or programs during the study * to adhere to diet recommendation during the study * 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. Written informed consent
Exclusion criteria
1. Known allergy or hypersensitivity to the components of the investigational products or source plants 2. Pathological electrocardiogram (ECG) at V1 3. History and/or presence of clinically significant condition/disorder, which per investigator's judgement could interfere with the results of the study or the safety of the subject, e.g.: * untreated or unstable thyroid gland disorder * untreated or unstable hypertension (regular blood pressure \>140/90 mm Hg) * 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 unstable diabetes mellitus type 2 * any other serious organ or systemic diseases that could influence the conduct and/or outcome of the study and/or could affect the tolerability of the subject 4. Significant surgery within the last 6 months prior to V1: * GI surgery * liposuction 5. History of eating disorders like bulimia, anorexia nervosa, binge-eating within the last 12 months prior to V1 6. 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) 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.) 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. Women of child-bearing potential: pregnancy or nursing 11. History of or current abuse of drugs, alcohol or medication 12. Participation in another clinical study in the 30 days prior to V1 and during the study 13. Any other reason for exclusion as per investigator's judgment, e.g. insufficient compliance with study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in mean body weight (kg) of overweight subjects | 52 weeks | Difference in mean body weight (kg) of overweight subjects after 52 weeks of IP intake in comparison between verum and placebo |
Secondary
| Measure | Time frame |
|---|---|
| Difference in mean body weight (kg) of all subjects | 52 weeks |
| Difference in mean body weight (kg) of obese subjects | 52 weeks |
| Proportion of subjects who lost at least 3%, 5% and 10% of baseline body weight | 52 weeks |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse effects | 52 weeks | Assessment of adverse events throughout the study |
| Safety parameters (Lab parameters, vital signs) | 52 weeks | Assessment of laboratory results in full blood count, clinical chemistry, blood pressure and pulse rate |
Countries
Germany
Outcome results
None listed