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The study aims to evaluate the effect of Litramine on fecal fat excretion in healthy subjects, to provide more comprehensive and robust clinical evidence in its mode of action for the treatment of obesity and weight management through dietary fat binding.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Litramine | Active Comparator | 2 tablets 3 times daily (oral consumption, 30 minutes after meal) |
|
| Placebo | Placebo Comparator | 2 tablets 3 times daily (oral consumption, 30 minutes after meal) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Litramine | Device | 2 tablets 3 times daily (oral consumption, 30 minutes after meal) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Difference between Litramine and placebo in changes of percentage fecal fat excretion after intervention | The amount of fat excreted in the feces will be quantified by the near-infrared reflectance analysis (NIRA) | 7 days per intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Full blood count | Analysis of hemoglobin, hematocrit, erythrocytes, thrombocytes, and leucocytes | Approximately 45 days |
| Clinical chemistry | Liver function, renal function, protein metabolism, lipid metabolism |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Regina Busch, MD | analyze & realize AG | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weißenseer Weg 111 | Berlin | State of Berlin | 10369 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25067985 | Derived | Uebelhack R, Busch R, Alt F, Beah ZM, Chong PW. Effects of cactus fiber on the excretion of dietary fat in healthy subjects: a double blind, randomized, placebo-controlled, crossover clinical investigation. Curr Ther Res Clin Exp. 2014 Jun 21;76:39-44. doi: 10.1016/j.curtheres.2014.02.001. eCollection 2014 Dec. |
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| Placebo |
| Device |
2 tablets 3 times daily (oral consumption, 30 minutes after meal) |
|
| Approximately 45 days |
| Blood pressure | Sitting blood pressure and heart rate will be measured using standard devices | Approximately 45 days |