Evidence mapPaperPMID 42397564Full record

Trial reportEuropean journal of nutrition2026

A carotenoid-rich functional tomato sauce (OsteoCol®) reduces liver fat content in adults with metabolic dysfunction-associated steatotic liver disease: a randomized clinical trial.

Rosario Mare, Yvelise Ferro, Samantha Maurotti, Elisa Mazza, Alberto Castagna, Carmelo Pujia, Francesca Rita Noto, Angelo Galluccio, Angela Mirarchi, Giuseppe Andrea Giampà and 3 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in European journal of nutrition, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Rosario Mare *Department of Medical and Surgical Sciences, University Magna Græcia, Catanzaro, Italy.
Yvelise Ferro *Department of Medical and Surgical Sciences, University Magna Græcia, Catanzaro, Italy.
Samantha MaurottiDepartment of Clinical and Experimental Medicine, University Magna Græcia, Catanzaro, Italy.
Elisa MazzaDepartment of Clinical and Experimental Medicine, University Magna Græcia, Catanzaro, Italy.
Alberto CastagnaDepartment of Medical and Surgical Sciences, University Magna Græcia, Catanzaro, Italy. a.castagna@unicz.it.
Carmelo PujiaClinical Nutrition Unit, AOU "Renato Dulbecco", Catanzaro, Italy.
Francesca Rita NotoDepartment of Medical and Surgical Sciences, University Magna Græcia, Catanzaro, Italy.
Angelo GalluccioClinical Nutrition Unit, AOU "Renato Dulbecco", Catanzaro, Italy.
Angela MirarchiDepartment of Medical and Surgical Sciences, University Magna Græcia, Catanzaro, Italy.
Giuseppe Andrea GiampàClinical Nutrition Unit, AOU "Renato Dulbecco", Catanzaro, Italy.
Marta MoracaClinical Nutrition Unit, AOU "Renato Dulbecco", Catanzaro, Italy.
Tiziana MontalciniDepartment of Clinical and Experimental Medicine, University Magna Græcia, Catanzaro, Italy.
Arturo PujiaDepartment of Medical and Surgical Sciences, University Magna Græcia, Catanzaro, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMetabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) is a common condition characterized by liver fat accumulation, and it has become a leading cause of liver-related morbidity and mortality worldwide. Currently, no drugs are approved to prevent or treat this condition. Carotenoids, especially lycopene, a potent antioxidant present in tomatoes, have demonstrated potential benefits for liver health in both preclinical and clinical studies. However, the lycopene content differs between tomatoes according to maturity stage. Ripening is an agronomic technique that enhances lycopene content by allowing tomatoes to fully mature on the plant. This study aimed to assess the effect of a carotenoid-rich tomato sauce made from vine-ripened tomatoes (OsteoCol®, patent N°:102019000000061 on liver fat in adults with MASLD.

methodsA total of 98 patients were enrolled in a double-blind, placebo-controlled clinical trial. The protocol was approved by the local Ethics Committee (124/2022/CE). The intervention group consumed the carotenoid-rich tomato sauce (OsteoCol®), while the control group received a commercial tomato sauce as a placebo for a total of 12 weeks. The main outcome was the variation in hepatic fat content (CAP score). CAP score, by transient elastography, serum glucose, lipids, and transaminases were measured at baseline and after treatment. We also investigated the effect of OsteoCol® extract on rat hepatoma cells and human hepatocellular carcinoma cell lines.

resultsA greater reduction in liver fat content was observed in participants consuming OsteoCol® compared to those receiving the placebo (CAP score: - 33 ± 44 dB/m vs. - 12 ± 38 dB/m, p = 0.014). The percentage reduction in the CAP score was even greater in men, individuals aged 60 and older, those with normal weight/overweight, and adults with mild hepatic steatosis at baseline. Additionally, in vitro studies on hepatic cell lines supported the clinical findings by demonstrating that OsteoCol® extract significantly reduced intracellular lipid accumulation through modulation of lipogenesis, β-oxidation, and cholesterol synthesis pathways.

conclusionsA functional tomato sauce made from vine-ripened tomatoes reduced liver fat content in adults with MASLD. This carotenoid-rich tomato sauce could serve as a novel nutritional strategy for patients with MASLD. Trial registration ISRCTN, ISRCTN10483954. Registered 04 June 2025-retrospectively registered, https://doi.org/10.1186/ISRCTN10483954.

Indexed as

CarotenoidsFatty LiverFunctional FoodLiverSolanum lycopersicumAdultAgedAntioxidantsDouble-Blind MethodFemaleHumansLycopeneMaleMiddle AgedAntioxidantsCarotenoidsLycopeneFunctional foodsHepatic steatosisLycopeneMetabolic dysfunction-associated steatotic liver diseaseTomato sauce

Identifiers

PMID42397564
PMCPMC13331848

What Socratic holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.