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Non-Alcoholic Fatty Liver Disease (NAFLD) is one of the most prevalent chronic liver diseases in Brazil and its treatment is still limited. Thus, this project aims to conduct a double-blind, controlled, randomized clinical trial to evaluate the effect of silymarin on laboratory markers and clinical evolution of adult patients with NAFLD treated at Edgard Santos Hospital, as well as identify the dietary pattern of these individuals.
Non-Alcoholic Fatty Liver Disease (NAFLD) is one of the most prevalent chronic liver diseases in Brazil. It has a significantly increasing incidence today and is considered an important global health problem. It affects approximately 20 to 30% of the adult population and increases according to the severity of the risk factors. The diagnosis of this disease usually occurs in 10 to 20% of the non-obese individuals, 50% in the overweight and 80 to 90% in the obese, being twice as present in individuals with Metabolic Syndrome. Pharmacological treatment options for NAFLD are still limited and Silybum marianum, one of the most sought-after herbal remedies in patients with liver disease, is commonly used by patients because of the claim of the hepatoprotective effect of silymarin. Studies have demonstrated the therapeutic potential of silymarin in patients with NAFLD, but clinical trials with more judicious methodological designs is still needed to prove these effects. Thus, this project aims to evaluate the efficacy of silymarin in adult patients with NAFLD seen at the Clinic of Nutrition and Hepatology of Edgard Santos Hospital. A randomized, double-blind, controlled clinical trial lasting 12 weeks will be performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Silymarin | Active Comparator | Patients will receive 2 capsules containing a total of 700mg of silymarin, 8mg of vitamin E and 50mg of phosphatidylcholine, in addition to the excipient, which should be ingested daily for 12 weeks. |
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| Placebo | Placebo Comparator | Patients will also receive similarly 2 capsules per day, but without the bioactive principle tested (silymarin). Therefore, the capsules in the control group will contain only 700 mg of maltodextrin, a neutral food component derived from starch, in addition to the excipient and the same amount of vitamin E and phosphatidylcholine to balance the two groups. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Silymarin | Dietary Supplement | It is a randomized, double-blind, controlled clinical trial to be performed at outpatient level. The intervention will last 12 weeks and the invited participants will be patients attended at the outpatient clinic of the Edgard Santos Hospital, which will be randomized into two groups: control and intervention. Data on laboratory and clinical markers, imaging, nutritional and dietary assessment will be collected at the beginning and end of the trial for comparison purposes. |
| Measure | Description | Time Frame |
|---|---|---|
| Absence or change in NAFLD degree | Absence or change in NAFLD degree, assessed by the value of the difference in the attenuation coefficient between liver and spleen obtained by computed tomography of the upper abdomen performed at the beginning and at the end of the study. | They will be dosed at baseline and after 12 weeks of intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Lipid profile | Total cholesterol (mg/dL), LDL-cholesterol (mg/dL), HDL-cholesterol (mg/dL), VLDL-cholesterol (mg/dL) and triglycerides (mg/dL) will be measured before and after the intervention. | They will be dosed at baseline and after 12 weeks of intervention. |
| Fasting blood glucose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Camila Avelar | Contact | +55 (71)991540434 | +55 | contato@camilaavelar.com.br |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Camila Ribeiro de Avelar | Recruiting | Salvador | Estado de Bahia | 40.110.060 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36899430 | Derived | de Avelar CR, Nunes BVC, da Silva Sassaki B, Dos Santos Vasconcelos M, de Oliveira LPM, Lyra AC, Bueno AA, de Jesus RP. Efficacy of silymarin in patients with non-alcoholic fatty liver disease - the Siliver trial: a study protocol for a randomized controlled clinical trial. Trials. 2023 Mar 10;24(1):177. doi: 10.1186/s13063-023-07210-6. |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D012838 | Silymarin |
| ID | Term |
|---|---|
| D044947 | Flavonolignans |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 |
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Clinical trial, randomized, double-blind and controlled
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Double-blind
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Fasting blood glucose (mg/dL) will be measured before and after the intervention. |
| They will be dosed at baseline and after 12 weeks of intervention. |
| Glycated haemoglobin | Hb A1c (%) will be measured before and after the intervention. | They will be dosed at baseline and after 12 weeks of intervention. |
| Insulin | Insulin (µU/mL) will be measured before and after the intervention. | They will be dosed at baseline and after 12 weeks of intervention. |
| Serum Iron | Serum iron (mcg/dL) will be measured before and after intervention. | They will be dosed at baseline and after 12 weeks of intervention. |
| Transferrin saturation | Transferrin saturation (%) will be measured before and after intervention. | They will be dosed at baseline and after 12 weeks of intervention. |
| Serum ferritin | Serum ferritin will be evaluated in µg/L before and after intervention. | They will be dosed at baseline and after 12 weeks of intervention. |
| Hepatic transaminases | Alanine aminotransferase (ALT) and Aspartate Aminotransferase (AST) will be evaluated in U/L before and after intervention. | They will be dosed at baseline and after 12 weeks of intervention. |
| gamma glutamyl transferase | Gamma glutamyl transferase will be evaluated in U/L before and after intervention. | They will be dosed at baseline and after 12 weeks of intervention. |
| Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |