Litramine in Weight Maintenance

Study Overview
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Brief Summary
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The effect of Litramine on weight loss has previously been studied during a 12-week intervention period with promising results. The present study looks into the effect of weight maintenance using Litramine following initial weight loss, for a longer period of 24 weeks.

Official Title
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Double-blind, Randomized, Placebo-controlled Clinical Investigation to Evaluate the Safety and Efficacy of Litramine in Maintaining Body Weight Loss in Overweight and Obese Subjects

Conditions
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Weight Maintenance, Overweight, Obese

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Documented weight loss, achieved over the last 3 to 6 months either from participation in weight loss clinical trials or weight loss regimens, of at least 3% at the point of screening BMI 25-35 before initial weight loss Documented compliance (according to the investigator's judgement) to previous weight loss clinical trials/ regimens Exclusion Criteria: Known sensitivity to the ingredients of the device (citric acid, acacia or Fabaceae family) BMI < 18.5 Presence of other factor(s) that, in the investigator's judgement, should preclude subject participation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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>Identical to Litramine 2 tablets 3 times daily (oral consumption, after meal) | Dietary Supplement: Placebo<br>* Identical to Litramine tablets 2 tablets 3 times daily (oral consumption, after meal)<br>|
| Experimental: Litramine<br>Fibre complex of plant origin n tablet form 2 tablets 3 times daily (oral consumption, after meal) | Dietary Supplement: Litramine<br>* Fibre complex of plant origin in tablet form 2 tablets 3 times daily (oral consumption, after meal)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in Body Weight From Baseline to End of 24 Weeks | Change in body weight at the end of 24 weeks measured in kg using a calibrated scale. (positive values signify weight gain, while negative values signify weight reduction | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Waist and Hip Circumference (cm) | Changes from baseline to end of study | 24 weeks | 
| Body Mass Index (kg/m^2) | Changes from baseline to end of study | 24 weeks | 
| Full Blood Count | Erythrocytes, leukocytes, thrombocytes, haematocrit, haemoglobin, Mean corpuscular volume (MCV), Mean corpuscular haemaglobin (MCH) | 24 weeks | 
| Blood Pressure | Measured in mm Hg | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Weight maintenance, Overweight, Obese, Weight management