Treatment of hepatic steatosis in patients with NAFLD Digestive System
Conditions
Interventions
Participants were enrolled after providing written informed consent and were randomly assigned (by computer-generated random numbers) in a 1:1 ratio to one of two treatment groups:
Intervention group:
Sponsors
Regione Calabria
Eligibility
Sex/Gender
All
Age
30 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. NAFLD defined by a CAP score value =248 dB/m 2. Age 30 - 75 years
Exclusion criteria
Exclusion criteria: 1. Alcohol intake >30 g/day for men or >20 g/day for women 2. BMI = 35 kg/m² 3. Allergy to tomatoes and nickel 4. HBV, HCV, HIV infection 5. Pregnancy 6. Type 2 Diabetes Mellitus (T2DM) 7. Triglycerides > 250 mg/dL 8. Gastroesophageal reflux disease 9. Hepatic and renal failure 10. Cirrhosis of the liver and other chronic liver diseases 11. Gallstones 12. Chronic intestinal diseases 13. Chronic debilitating diseases 14. Parenteral nutrition 15. Use of specific drugs (amiodarone, antiretrovirals, corticosteroids, methotrexate, tamoxifen, valproate, or lipid-lowering drugs for less than 6 weeks) 16. Use of food supplements or functional foods aimed at reducing hepatic steatosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Amount of intrahepatic fat (i.e. Controlled Attenuation Parameter value, CAP score), assessed by Transient Vibration-Controlled Elastography (Fibroscan), at baseline and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| At baseline and 12 weeks: 1. Severity of NAFLD, assessed by FibroScan 2. LDL-cholesterol, measured using biochemical assays, after 12 weeks of treatment 3. Inflammation markers, measured using biochemical assays, after 12 weeks of treatment 4. Lipid accumulation (i.e., Lipid Accumulation Product, LAP) and cardiovascular risk markers (i.e., Atherogenic Index of Plasma, AIP) 5. Antioxidant status parameters, evaluated using ELISA kits | — |
Countries
Italy
Contacts
Public ContactArturo Pujia
Outcome results
None listed