An interventional study of Silymarin in Non-Alcoholic Fatty Liver Disease, sponsored by Camila Ribeiro de Avelar. Status unknown at 1 site in Brazil. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-08-02.
Sponsored by Camila Ribeiro de Avelar · Not applicable, Interventional, and Treatment
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.
2,083 studies on the registry are indexed under Liver Diseases; 392 are open to participants now.
This study's planned enrollment of 132 is above the median of 50 across 1,323 interventional studies indexed under Liver Diseases.
Browse Liver Diseases studies →This is the only study on the registry with Camila Ribeiro de Avelar as lead sponsor.
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Exclusion Criteria:
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.
Dietary Supplement: Silymarin
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.
Dietary Supplement: Silymarin
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.
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.
Time frame: They will be dosed at baseline and after 12 weeks of intervention.
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.
Time frame: They will be dosed at baseline and after 12 weeks of intervention.
Fasting blood glucose
Fasting blood glucose (mg/dL) will be measured before and after the intervention.
Time frame: They will be dosed at baseline and after 12 weeks of intervention.
Glycated haemoglobin
Hb A1c (%) will be measured before and after the intervention.
Time frame: They will be dosed at baseline and after 12 weeks of intervention.
Insulin
Insulin (µU/mL) will be measured before and after the intervention.
Time frame: 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.
Time frame: They will be dosed at baseline and after 12 weeks of intervention.
Transferrin saturation
Transferrin saturation (%) will be measured before and after intervention.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: They will be dosed at baseline and after 12 weeks of intervention.
Plan to share: No
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This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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