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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Identical to Litramine 2 tablets 3 times daily (oral consumption, after meal) |
|
| Litramine | Experimental | Fibre complex of plant origin n tablet form 2 tablets 3 times daily (oral consumption, after meal) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Litramine | Dietary Supplement | Fibre complex of plant origin in tablet form 2 tablets 3 times daily (oral consumption, after meal) |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barbara Grube | Berlin | State of Berlin | 10709 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26435849 | Derived | Grube B, Chong PW, Alt F, Uebelhack R. Weight Maintenance with Litramine (IQP-G-002AS): A 24-Week Double-Blind, Randomized, Placebo-Controlled Study. J Obes. 2015;2015:953138. doi: 10.1155/2015/953138. Epub 2015 Sep 7. |
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Trial conducted from January 2012 to September 2012 in two study sites in Germany
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Identical to Litramine 2 tablets 3 times daily (oral consumption, after meal) Placebo: Identical to Litramine tablets 2 tablets 3 times daily (oral consumption, after meal) |
| FG001 | Litramine | Fibre complex of plant origin in tablet form 2 tablets 3 times daily (oral consumption, after meal) Litramine: Fibre complex of plant origin in tablet form 2 tablets 3 times daily (oral consumption, after meal) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Identical to Litramine 2 tablets 3 times daily (oral consumption, after meal) Placebo: Identical to Litramine tablets 2 tablets 3 times daily (oral consumption, after meal) |
| BG001 | Litramine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Deviation | kg | 24 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Identical to Litramine 2 tablets 3 times daily (oral consumption, after meal) Placebo: Identical to Litramine tablets 2 tablets 3 times daily (oral consumption, after meal) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Felix Alt | Analyze & Realize | +49 30 40008100 | Falt@a-r.com |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Placebo | Dietary Supplement | Identical to Litramine tablets 2 tablets 3 times daily (oral consumption, after meal) |
|
| 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 |
Fibre complex of plant origin in tablet form 2 tablets 3 times daily (oral consumption, after meal)
Litramine: Fibre complex of plant origin in tablet form 2 tablets 3 times daily (oral consumption, after meal)
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Body weight (kg) | Mean | Standard Deviation | kg |
|
| BMI (kg/m^2) | Mean | Standard Deviation | kg/m^2 |
|
|
|
| Secondary | Waist and Hip Circumference (cm) | Changes from baseline to end of study | Not Posted | 24 weeks |
| Secondary | Body Mass Index (kg/m^2) | Changes from baseline to end of study | Not Posted | 24 weeks |
| Secondary | Full Blood Count | Erythrocytes, leukocytes, thrombocytes, haematocrit, haemoglobin, Mean corpuscular volume (MCV), Mean corpuscular haemaglobin (MCH) | Not Posted | 24 weeks |
| Secondary | Blood Pressure | Measured in mm Hg | Not Posted | 24 weeks |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Litramine | Fibre complex of plant origin in tablet form 2 tablets 3 times daily (oral consumption, after meal) Litramine: Fibre complex of plant origin in tablet form 2 tablets 3 times daily (oral consumption, after meal) | 0 | 25 | 0 | 25 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |