Effect of LIVOGEN, a nutraceutical containing natural bioactive components bergamot extract, artichoke leaf extract, Nigella sativa, EPA, DHA and silybin, on individuals affected by liver steatosis (fatty liver disease)
| ISRCTN | ISRCTN70887063 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70887063 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | n. 330, 22 October 2020 |
| Sponsor | Tishcon (United States) |
| Funder | Tishcon Corporation |
- Submission date
- 03/08/2021
- Registration date
- 02/09/2021
- Last edited
- 22/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
Non-alcoholic fatty liver disease (liver steatosis) is the most common cause of liver-related illness and death in the world. However, no effective drug treatment for this condition has been found. It has been demonstrated that Bergamot Bioactive Polyphenolic Fractions (BPF) associated to wild Cardoon, can reduce liver steatosis in subjects over 50 years. The aim of this study is to test the effect of a new nutraceutical containing natural bioactive components of Bergamot ext (BPF), Artichoke Leaf ext, Nigella Sativa, EPA, DHA, Silybin, etc ( namely LIVOGEN) 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 receives Livogen Plus® for 12 weeks. The control group receives 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. There are no risks for participants.
Where is the study run from?
University Magna Grecia (Italy)
When is the study starting and how long is it expected to run for?
October 2020 to December 2022
Who is funding the study?
Tishcon Corporation, Westbury, NY & Salisbury, MD (USA)
Who is the main contact?
Prof. Tiziana Montalcini, tmontalcini@unicz.it
Contact information
Scientific
viale Europa
Catanzaro
88100
Italy
 ORCID ID |
0000-0001-7048-5830 |
|---|---|
| Phone | +39 961 3697314 |
| tmontalcini@unicz.it |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | LIVOGEN in liver steatosis |
| Study acronym | LILIST study |
| Study objectives | The aim of the present study is to test the effect of a new nutraceutical containing natural bioactive components as Bergamot ext, Artichoke Leaf ext, Nigella Sativa, EPA, DHA, Silybin, etc (namely LIVOGEN) as treatment in individuals with liver steatosis. |
| Ethics approval(s) | Approved 22/10/2020 il Comitato Etico Regione Calabria Sezione Area Centro con sede presso (l’A.O.U. Mater Domini in Via Tommaso Campanella, 115 Catanzaro, Italy; +39 (0)961 712 111; comitatoetico@hotmail.it), ref: 330/2020/CE |
| Health condition(s) or problem(s) studied | Liver steatosis |
| Intervention | Participants will be enrolled after a written informed consent will be obtained and will be randomly assigned (by computer-generated random numbers) in a 1:1 ratio to receive either the nutraceutical or a placebo for up to 12 weeks The nutraceutical and placebo softgel capsules will be supplied by the Thishcon corp. The capsules will be similar in shape, size, and color. The Livogen Plus® study dose are the follow: 6 softgels daily, 3 with each main meal (lunch and dinner). The same for placebo. The enrollment period will be of at least 18 months. We will assess the CAP score by Elastography ( Fibroscan). The treatment period will last 3 months. |
| Intervention type | Supplement |
| Primary outcome measure(s) |
1. CAP score value will be measured by Fibroscan at baseline and after 12 weeks of treatment |
| Key secondary outcome measure(s) |
There are no secondary outcome measures |
| Completion date | 31/12/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 140 |
| Total final enrolment | 140 |
| Key inclusion criteria | 1. NAFLD defined by a CAP score value ≥247 dB/m 2. Age 30 - 75 years |
| Key exclusion criteria | 1. Taking nutraceuticals, supplements or functional food 2. Past and current alcohol abuse 3. Clinical and laboratory signs of chronic hepatitis B and/or C virus infection 4. Allergies to nutraceuticals components 5. Diabetes 6. Autoimmune or cholestatic liver disease, liver cirrhosis, 7. Pregnancy 8. Nephrotic syndrome, chronic renal failure 9. Gastroesophageal reflux 10. Cancer 11. Taking amiodarone, antiretroviral agents, corticosteroids, methotrexate, tamoxifen, valproate 12. Starting lipid-lowering drugs in the past month |
| Date of first enrolment | 12/07/2021 |
| Date of final enrolment | 08/10/2021 |
Locations
Countries of recruitment
- Italy
Study participating centre
Viale Europa
Campus Universitario S. Venuta
Catanzaro
88100
Italy
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request from Tiziana montalcini, tmontalcini@unicz.it; as SPSS dataset; it will become available from January 2023 upon journal request in the case of publication, after company approval only for data anonymisation. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 19/08/2022 | 22/08/2022 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
22/08/2022: Publication reference added.
11/10/2021: The total final enrolment number has been added.
01/10/2021: The recruitment end date has been changed from 30/10/2021 to 08/10/2021.
03/08/2021: Trial's existence confirmed by Comitato Etico Regione Calabria.
