Calabrian functional tomato sauce for the treatment of non-alcoholic fatty liver disease
| ISRCTN | ISRCTN10483954 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10483954 |
| Secondary identifying numbers | 124/2022/CE |
- Submission date
- 27/05/2025
- Registration date
- 04/06/2025
- Last edited
- 03/06/2025
- 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 worldwide. However, no approved drug treatments currently exist for this condition. Lycopene, a powerful antioxidant found in tomatoes, has shown potential benefits for liver health. OsteoCol® is a lycopene-enriched tomato sauce obtained through on-vine ripening, which increases its natural lycopene content. This study aims to evaluate the effect of daily consumption of OsteoCol® tomato sauce as a functional food for the treatment of patients with liver steatosis.
Who can participate?
Adult patients adults of both genders, aged 30-75 years, with a diagnosis of NAFLD.
What does the study involve?
Participants are allocated with a simple randomization using computer-generated random numbers to the intervention or the control group. Ninety-eight adults were randomly assigned to two groups for 12 weeks, as follows:
Intervention group: Participants received a functional tomato sauce (OsteoCol®), naturally enriched with lycopene. Twenty-five participants consumed 80 g/day, while twenty-four participants consumed 160 g every other day.
Control group: Participants received a commercial tomato sauce. Twenty-five participants consumed 80 g/day, while twenty-four participants consumed 160 g every other day.
The primary outcome measured was a change in the amount of intrahepatic fat, assessed by CAP score, after a 12-week intervention between groups.
What are the possible benefits and risks of participating?
The potential benefit is a reduction in the amount of liver fat and an improvement in the severity of NAFLD. There are no risks to 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?
From April 2022 to August 2023.
Who is funding the study?
This study was supported by a Grant from Calabria Region, Italy (Bando INGEGNO - POR CALABRIA FESR-FSE 2014/2020-SALNAF “Functional Calabrian Tomato Sauce Naturally Rich in Lycopene for the Treatment of Non-Alcoholic Fatty Liver Disease”).
Who is the main contact?
Prof. Arturo Pujia, pujia@unicz.it
Contact information
Public, Scientific, Principal Investigator
Viale Europa, Campus Universitario S. Venuta
Catanzaro
88100
Italy
 ORCID ID |
0000-0003-0763-4930 |
|---|---|
| Phone | + 39 0961 3697080 |
| pujia@unicz.it |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Community |
| Study type | Treatment |
| Participant information sheet | 47407_PIS.pdf |
| Scientific title | SALNAF – Calabrian functional tomato sauce naturally rich in lycopene for the treatment of non-alcoholic fatty liver disease |
| Study acronym | SALNAF |
| Study objectives | Non-alcoholic fatty liver disease (liver steatosis) is the most common cause of liver-related illness and death worldwide. However, no approved drug treatments currently exist for this condition. Lycopene, a powerful antioxidant found in tomatoes, has shown potential benefits for liver health. OsteoCol® is a lycopene-enriched tomato sauce obtained through on-vine ripening, which increases its natural lycopene content. This study aims to evaluate the effect of daily consumption of OsteoCol® tomato sauce as a functional food for the treatment of patients with liver steatosis. |
| Ethics approval(s) |
Approved 21/04/2022, Comitato Etico Regione Calabria Sezione Area Centro (A.O.U. Mater Domini in Via Tommaso Campanella, 115, Catanzaro, 88100, Italy; +39 (0)961 712 111; comitatoetico@hotmail.it), ref: 124/2022/CE |
| Health condition(s) or problem(s) studied | Treatment of hepatic steatosis in patients with NAFLD |
| Intervention | Participants were enrolled after providing written informed consent and were randomly assigned (by computer-generated random numbers) in a 1:1 ratio to one of two treatment groups: Intervention group: Participants received a functional tomato sauce (OsteoCol®), naturally enriched with lycopene. Twenty-five participants consumed 80 g/day, while twenty-four participants consumed 160 g every other day. Control group: Participants received a commercial tomato sauce. Twenty-five participants consumed 80 g/day, while twenty-four participants consumed 160 g every other day |
| Intervention type | Other |
| Primary outcome measure | Amount of intrahepatic fat (i.e. Controlled Attenuation Parameter value, CAP score), assessed by Transient Vibration-Controlled Elastography (Fibroscan), at baseline and 12 weeks |
| Secondary outcome measures | At baseline and 12 weeks: 1. Severity of NAFLD, assessed by FibroScan 2. LDL-cholesterol, measured using biochemical assays, after 12 weeks of treatment 3. Inflammation markers, measured using biochemical assays, after 12 weeks of treatment 4. Lipid accumulation (i.e., Lipid Accumulation Product, LAP) and cardiovascular risk markers (i.e., Atherogenic Index of Plasma, AIP) 5. Antioxidant status parameters, evaluated using ELISA kits |
| Overall study start date | 21/04/2022 |
| Completion date | 29/08/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 30 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | 98 |
| Total final enrolment | 98 |
| Key inclusion criteria | 1. NAFLD defined by a CAP score value ≥248 dB/m 2. Age 30 - 75 years |
| Key exclusion criteria | 1. Alcohol intake >30 g/day for men or >20 g/day for women 2. BMI ≥ 35 kg/m² 3. Allergy to tomatoes and nickel 4. HBV, HCV, HIV infection 5. Pregnancy 6. Type 2 Diabetes Mellitus (T2DM) 7. Triglycerides > 250 mg/dL 8. Gastroesophageal reflux disease 9. Hepatic and renal failure 10. Cirrhosis of the liver and other chronic liver diseases 11. Gallstones 12. Chronic intestinal diseases 13. Chronic debilitating diseases 14. Parenteral nutrition 15. Use of specific drugs (amiodarone, antiretrovirals, corticosteroids, methotrexate, tamoxifen, valproate, or lipid-lowering drugs for less than 6 weeks) 16. Use of food supplements or functional foods aimed at reducing hepatic steatosis |
| Date of first enrolment | 27/03/2023 |
| Date of final enrolment | 31/05/2023 |
Locations
Countries of recruitment
- Italy
Study participating centre
Catanzaro
88100
Italy
Sponsor information
Government
Viale Europa - Zona Tramontana - Cittadella Regionale
Catanzaro
88100
Italy
| Phone | +39 0961 858524 |
|---|---|
| programmazione@regione.calabria.it | |
| Website | https://www.regione.calabria.it |
"ROR" |
https://ror.org/03swz0133 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/06/2025 |
|---|---|
| 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 | Individual participant data (IPD) that underlie the results reported in the main publication (including baseline data, primary outcomes, and secondary outcomes) will be made available after de-identification. The data will be accessible beginning 6 months after publication and for up to 5 years, to researchers who provide a methodologically sound proposal. Data will be shared in accordance with participant consent and applicable ethical guidelines. A data-sharing agreement may be required. Requests should be directed to pujia@unicz.it. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 03/06/2025 | No | Yes |
Additional files
Editorial Notes
03/06/2025: Study's existence confirmed by the Comitato Etico Regione Calabria Sezione Area Centro.
