Efficacy and Safety of Litramine in 1 Year Weight Loss Study

Study Overview
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Brief Summary
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To evaluate the efficacy of Litramine in reducing body weight in the context of an energy-restricted diet in overweight and moderately obese subjects

Official Title
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Double-blind, Randomised, Placebo-controlled 1-year Study to Evaluate the Efficacy and Safety of Litramine in Reducing Body Weight in Overweight and Moderately Obese Subjects

Conditions
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Obesity; Excess Calories, Overweight and Obesity, Weight Loss

Intervention / Treatment
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* Dietary Supplement: Litramine
* Dietary Supplement: Placebo tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women from 18 to 70 years old 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 Generally in good health Desire to lose weight Readiness and ability to complete the 1-year study, according to investigator's judgement following the screening interview Accustomed to regular daily consumption of 3 main meals (breakfast, lunch, dinner) Consistent and stable body weight in the last 3 months prior to V1 (less than 5% self- reported change) 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 Women of childbearing potential: commitment to use contraception methods negative pregnancy testing (beta human chorionic gonadotropin test in urine) at V1 Written informed consent Exclusion Criteria: Known allergy or hypersensitivity to the components of the investigational products or source plants Pathological electrocardiogram (ECG) at V1 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 Significant surgery within the last 6 months prior to V1: GI surgery liposuction History of eating disorders like bulimia, anorexia nervosa, binge-eating within the last 12 months prior to V1 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) Any electronic medical implant 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.) 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) Women of child-bearing potential: pregnancy or nursing History of or current abuse of drugs, alcohol or medication Participation in another clinical study in the 30 days prior to V1 and during the study Any other reason for exclusion as per investigator's judgment, e.g. insufficient compliance with study procedures

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo tablet<br>* 2 tablets to be taken 3 times a day after meals<br>|
| Experimental: Litramine<br> | Dietary Supplement: Litramine<br>* 2 tablets to be taken 3 times a day after meals<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in mean body weight (kg) of overweight subjects | Difference in mean body weight (kg) of overweight subjects after 52 weeks of IP intake in comparison between verum and placebo | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Litramine, Opuntia ficus-indica, weight loss