Bergamot and Cardoon extract for liver disease
- Conditions
- iver steatosisDigestive SystemFatty (change of) liver, not elsewhere classified
- Registration Number
- ISRCTN12833814
- Lead Sponsor
- Italian Ministry of University and Research (MIUR)
- Brief Summary
2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32849284/ results (added 02/09/2020) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36556930/ (added 06/09/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 102
1. Over 30 years old
2. Both genders
3. Liver steatosis defined by CAP score over 216 dB/m
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method iver fat content and/or liver steatosis markers measured by transient elastography (Fibroscan) at baseline and after 12 weeks
- Secondary Outcome Measures
Name Time Method Measured at baseline and after 12 weeks:<br>1. Disease progression measured by liver elastography <br>2. Insulin resistance measured by colorimetric test<br>3. Lipids in blood measured by colorimetric test<br>4. PCSK9 modulation measured by ELISA/colorimetric test<br>5. Inflammatory markers measured by colorimetric test<br>6. Endothelial function and other hemodynamic parameters measured by Endo-PAT