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Our preliminary reports have found in silico and in vitro that the milk thistle derivative Silibinin(A) is able to inhibit pancreatic lipase, in a similar way that the classical anti-obesity drug orlistat.
Therefore, the investigators want to carry out the present trial in order to confirm that Silibinin(A) is able to in vivo inhibit pancreatic lipase, which will reduce the fat absorption and therefore will decrease the amount of energy from food intake.
Considering that milk thistle has been extensively studied in humans as liver-protector, the investigators consider that the use of human subjects will be of great interest to accelerate the employment of this compound to improve the effectiveness of dietary treatment in overweight/obese subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INTERVENTION | Experimental | Silibinin (A) for three months, with an administration regimen of 3 oral doses of 300 mg per day, before each main meal. |
|
| CONTROL | Placebo Comparator | Similar treatment regimen, but with a placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Silibinin A | Dietary Supplement | The compound will be administered following a 300 mg / 3 day schedule, before each main meal. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of total body weight loss | Change in body weight from baseline to the end of study period (3 months). | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma total cholesterol | Change in plasma total cholesterol levels from baseline to the end of study period (3 months). | 3 months |
| Plasma low density level cholesterol (cLDL) | Change in plasma cLDL levels from baseline to the end of study period (3 months). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juan José Hernández Morante, PhD | Catholic University of Murcia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Nursing. Catholic University of Murcia | Murcia | 30107 | Spain |
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| Label | URL |
|---|---|
| Webpage of the research group and contact info. | View source |
| Webpage of other collaborators | View source |
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The data derived from the present trial will be located in public domain databases, concretely in the Mendeley data repository (https://data.mendeley.com/). Nevertheless, all data will be available by request to the main researcher, Dr. Juan José Hernández Morante (e-mail:jjhernandez@ucam.edu).
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D006937 | Hypercholesterolemia |
| D015228 | Hypertriglyceridemia |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D000077385 | Silybin |
| ID | Term |
|---|---|
| D012838 | Silymarin |
| D044947 | Flavonolignans |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 |
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| 3 months |
| Plasma triglycerides | Change in plasma triglyceride levels from baseline to the end of study period (3 months). | 3 months |
| Body mass index (BMI) | Change in BMI from baseline to the end of study period. | 3 months |
| Body fat percentage | Change in body fat from baseline to the end of study period. | 3 months |
| Waist circumference | Change in waist circumference from baseline to the end of study period. | 3 months |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |