Condition category
Digestive System
Date applied
05/08/2019
Date assigned
07/08/2019
Last edited
07/08/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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
Pujia@unicz.it
2. Prof. Vincenzo Mollace
Mollace@unicz.it

Trial website

Contact information

Type

Scientific

Primary contact

Prof Arturo Pujia

ORCID ID

Contact details

viale Europa Campus S. Venuta
Magna Grecia University
sn
Catanzaro
88100
Italy
+39 (0)3316718206
pujia@unicz.it

Type

Scientific

Additional contact

Prof Vincenzo Mollace

ORCID ID

Contact details

Research Centre for Food Safety and Health (IRC-FSH)
viale Europa
Campus S. Venuta
Magna Grecia University
Catanzaro
88100
Italy
+39 (0)3316718386
mollace@unicz.it

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

219/2018/CE

Study information

Scientific 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

Study hypothesis

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.

Ethics approval

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: comitatoetico@hotmail.it; michelangelo.rossano@regione.calabria.it), ref: 219/2018/CE

Study design

Double-blind placebo-controlled clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Liver steatosis

Intervention

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.

Intervention type

Supplement

Phase

Drug names

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

01/06/2018

Overall trial end date

30/09/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Over 30 years old
2. Both genders
3. Liver steatosis defined by CAP score over 216 dB/m

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

102

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
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)

Recruitment start date

11/02/2019

Recruitment end date

10/04/2019

Locations

Countries of recruitment

Italy

Trial participating centre

Clinical Nutrition Unit of the “Mater Domini” Azienda University Hospital
viale Europa , Campus S. Venuta, University Magna Grecia
Catanzaro
88100
Italy

Sponsor information

Organisation

Italian Ministry of University and Research (MIUR)

Sponsor details

viale G. Ribotta 5
Rome
00144
Italy
+39 06 59941
minsalute_estero.dgprog@sanita.it

Sponsor type

Government

Website

www.salute.gov.it

Funders

Funder type

Government

Funder name

Ministero dell’Istruzione, dell’Università e della Ricerca Nutramed Project, PON 03PE000_78_1

Alternative name(s)

Ministry of Education, University and Research, Ministry of Education, Universities and Research, MIUR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

Italy

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

02/06/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

07/08/2019: Trial's existence confirmed by ethics committee.