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 |
| Secondary identifying numbers | n. 330, 22 October 2020 |
- 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
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
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | LIVOGEN in liver steatosis |
| Study acronym | LILIST study |
| Study hypothesis | 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 |
| Condition | 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 | 1. CAP score value will be measured by Fibroscan at baseline and after 12 weeks of treatment 2. Serum lipid (cholesterol, HDL-cholesterol, and triglycerides) profile will be assessed by chemiluminescent immunoassay at baseline and after 12 weeks of treatment 3. AST, ALT, and GGT will be measured by chemiluminescent immunoassay at baseline and after 12 weeks of treatment Insulin will be determined by chemiluminescent immunoassay at baseline and after 12 weeks of treatment 4. C-reactive protein (CRP) will be measured by chemiluminescent immunoassay at baseline and after 12 weeks of treatment. 5. Serum interleukin-1β (IL-1β), interleukin-6 (IL-6), and tumor necrosis factor α (TNF-α) will be determined by sandwich enzyme-linked immunosorbent assay (ELISA) at baseline and after 12 weeks of treatment at baseline and after 12 weeks of treatment. |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 22/10/2020 |
| Overall study end date | 31/12/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 140 |
| Total final enrolment | 140 |
| Participant inclusion criteria | 1. NAFLD defined by a CAP score value ≥247 dB/m 2. Age 30 - 75 years |
| Participant 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 |
| Recruitment start date | 12/07/2021 |
| Recruitment end date | 08/10/2021 |
Locations
Countries of recruitment
- Italy
Study participating centre
Viale Europa
Campus Universitario S. Venuta
Catanzaro
88100
Italy
Sponsor information
Industry
2410 W Zion Rd
Salisbury
21801
United States of America
| Phone | +1 410-860-0046 |
|---|---|
| qgel@tishcon.com | |
| Website | https://www.tishcon.com/ |
"ROR" |
https://ror.org/0133gy560 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 30/01/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Publication and dissemination plan: Publication in journal in English with impact factor; mass media. |
| 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 |
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.
