Preclinical evaluation of an innovative dietary intervention for non-alcoholic hepatic steatosis in Sprague-Dawley rats

Abstract

Objective: We developed an innovative food (IF) designed for special nutritional needs, intended as an adjuvant in the prevention or treatment of non-alcoholic hepatic steatosis. This study evaluates its preclinical effectiveness, with results aimed to inform future clinical trial design in more homogeneous patient populations.

Methods: This preclinical experimental study involved 32 Sprague-Dawley rats divided into four groups: a Control group (standard diet), a High-Fat Diet (HFD) group (30% and 60% fat), Experimental group 1 (HFD followed by IF), and Experimental group 2 (HFD and IF administered concurrently). Body weight, urine, blood glucose, and 11 hepatic parameters were measured at the end of the induction and intervention phases.

Results: HFD increased energy intake, weight gain, and fat mass, particularly in males. A decrease in food and water intake was noted during the induction phase in groups fed HFD. The HFD group showed persistent signs of liver stress. Experimental Group 1 showed consistent improvements, with individual variability in response to IF intervention. Experimental Group 2 showed significant results during induction stages, indicating a stronger protective effect.

Conclusions: A 30% fat HFD over 10 weeks was insufficient to induce hepatic steatosis, while a 60% fat HFD over 15 weeks successfully induced obesity and liver pathology. Post-induction IF intervention reduced weight gain and improved liver markers. Blood glucose, transaminases, alkaline phosphatase, and total cholesterol levels suggest that IF has protective effects, supporting its potential use in preventing and managing non-alcoholic fatty liver disease.