Plain English Summary
Background and study aims
Non-alcoholic fatty liver disease is the most common cause of liver-related morbidity and mortality in the world. However, no effective drug treatment for this condition has been found. Oxidative stress is one of the key mediators of liver damage and represents a major contributor to the progression from simple steatosis to cirrhosis. It has been demonstrated that Bergamot (Citrus bergamia Risso et Poiteau) flavonoids decrease liver inflammation. Wild cardoon (Cynara cardunculus L.), is rich in antioxidant compounds which possess anti-inflammatory properties. The aim of this study is to test the effect of a new nutraceutical containing natural bioactive components from Bergamot and wild Cardoon, with antioxidant proprieties, as a treatment for patients with liver steatosis.
Who can participate?
Patients aged 30 and over with liver steatosis
What does the study involve?
Participants are randomly allocated to the intervention group or the control group. The intervention group receive Bergacyn®, containing a Bergamot polyphenol fraction and Cynara Cardunculus extract, for 12 weeks. The control group receive a placebo (dummy pill) daily for 12 weeks. Liver fat content is measured at the start and the end of the study.
What are the possible benefits and risks of participating?
All participants receive a liver disease screening for free. No risks are expected.
Where is the study run from?
University Magna Grecia (Italy)
When is the study starting and how long is it expected to run for?
June 2018 to September 2019
Who is funding the study?
Ministry of Education, Universities and Research (Italy)
Who is the main contact?
1. Prof. Arturo Pujia
2. Prof. Vincenzo Mollace
Prof Arturo Pujia
viale Europa Campus S. Venuta
Magna Grecia University
Prof Vincenzo Mollace
Research Centre for Food Safety and Health (IRC-FSH)
Campus S. Venuta
Magna Grecia University
Effects of Bergamot (Citrus bergamia Risso et Poiteau) and wild cardoon (Cynara cardunculus L.) extract intake on non-alcoholic fatty liver disease (NAFLD)
Given the key roles of oxidation and inflammation in the pathogenesis of liver steatosis and the promising role for natural antioxidants, in this study the aim was to test the effect of a new nutraceutical containing Bergamot and wild Cardoon extract.
Approved 24/09/2018, local ethical committee at the “Mater Domini” Azienda University Hospital (viale T. Campanella, Catanzaro, Italy; Tel: +39 (0)961 712 111; Email: firstname.lastname@example.org; email@example.com), ref: 219/2018/CE
Double-blind placebo-controlled clinical trial
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
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 bergamot polyphenolic fraction (BPF®), and wild type Cynara Cardunculus extract plus excipients including PUFA 380 mg and a mixture of bergamot pulp and albedo derivative]. (registered Patents RM2008A000615, PCT/IB2009/055061 and 102017000040866)
2. Placebo: one softgel pill containing maltodextrin 300 mg plus excipients including PUFA 380 mg
Both groups receive the intervention for 12 weeks. Liver fat content, measured by transient elastography (Fibroscan), serum transaminases, lipids and glucose will be measured at the baseline and the end of the study.
Primary outcome measure
Liver fat content and/or liver steatosis markers measured by transient elastography (Fibroscan) at baseline and after 12 weeks
Secondary outcome measures
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
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
1. Over 30 years old
2. Both genders
3. Liver steatosis defined by CAP score over 216 dB/m
Target number of participants
Participant 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
8. Nephrotic syndrome
9. Chronic renal failure
10. Gastroesophageal reflux
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)
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Clinical Nutrition Unit of the “Mater Domini” Azienda University Hospital
viale Europa , Campus S. Venuta, University Magna Grecia
Ministero dell’Istruzione, dell’Università e della Ricerca Nutramed Project, PON 03PE000_78_1
Ministry of Education, University and Research, Ministry of Education, Universities and Research, MIUR
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Publication in journal in English with impact factor; mass media.
IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Pujia (Pujia@unicz.it).
Intention to publish date
Participant level data
Available on request
Basic results (scientific)