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

BACKGROUND

Metabolic 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.

METHODS

A 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.

RESULTS

A 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.

CONCLUSIONS

A 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.