Liver steatosis Digestive System Fatty (change of) liver, not elsewhere classified
Conditions
Interventions
Participants are randomized by simple randomization to:
1. Bergacyn® (provided by Herbal & Antioxidant SRL, Bianco, RC, Italy): one softgel pill containing 300 mg of a combination product containing b
Sponsors
Italian Ministry of University and Research (MIUR)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Over 30 years old 2. Both genders 3. Liver steatosis defined by CAP score over 216 dB/m
Exclusion criteria
Exclusion criteria: 1. Past and current alcohol abuse 2. Clinical and laboratory signs of chronic hepatitis B and/or C virus infection 3. Allergies to cardoon, artichoke or maize 4. Triglycerides concentration over 250 mg/dl 5. Autoimmune or cholestatic liver disease 6. Liver cirrhosis 7. Pregnancy 8. Nephrotic syndrome 9. Chronic renal failure 10. Gastroesophageal reflux 11. Cancer 12. Taking amiodarone, antiretroviral agents, corticosteroids, methotrexate, tamoxifen, valproate. The study's protocol allowed to enrol only long-term lipid-lowering drugs users (more than 6 weeks)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Liver fat content and/or liver steatosis markers measured by transient elastography (Fibroscan) at baseline and after 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured at baseline and after 12 weeks: 1. Disease progression measured by liver elastography 2. Insulin resistance measured by colorimetric test 3. Lipids in blood measured by colorimetric test 4. PCSK9 modulation measured by ELISA/colorimetric test 5. Inflammatory markers measured by colorimetric test 6. Endothelial function and other hemodynamic parameters measured by Endo-PAT | — |
Countries
Italy
Outcome results
None listed