A carotenoid-rich functional tomato sauce (OsteoCol®) reduces liver fat content in adults with metabolic dysfunction-associated steatotic liver disease: a randomized clinical trial
Abstract
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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 98 participants or records.
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