| Trial ID: | L0459 |
| Source ID: | ISRCTN12833814
|
| Associated Drug: |
Bergamot
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| Title: |
Effects of Bergamot (Citrus bergamia Risso et Poiteau) and wild cardoon (Cynara cardunculus L.) extract intake on non-alcoholic fatty liver disease (NAFLD)
|
| Acronym: |
--
|
| Status: |
Not Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Liver steatosis <br>Digestive System <br>Fatty (change of) liver, not elsewhere classified
|
| Interventions: |
<br> Participants are randomized by simple randomization to:<br> 1. Bergacyn?? (provided by Herbal & Antioxidant SRL, Bianco, RC, Italy): one softgel pill containing 300 mg of a combination product containing bergamot polyphe
|
| Outcome Measures: |
Liver fat content and/or liver steatosis markers measured by transient elastography (Fibroscan) at baseline and after 12 weeks<br> 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<br>
|
| Sponsor/Collaborators: |
Italian Ministry of University and Research (MIUR)
|
| Gender: |
All
|
| Age: |
nannan
|
| Phases: |
Not applicable
|
| Enrollment: |
102
|
| Study Type: |
Interventional
|
| Study Designs: |
Double-blind placebo-controlled clinical trial (Treatment)
|
| Start Date: |
07/08/2019
|
| Completion Date: |
30/09/2019
|
| Results First Posted: |
--
|
| Last Update Posted: |
14 September 2020
|
| Locations: |
Italy
|
| URL: |
http://isrctn.com/ISRCTN12833814
|
