New Specialized Food Product “SPP1” in Combination With Iso-Calorie Diet Shows Better Efficacy Than the Diet Alone in Treatment of Non-alcoholic Steatohepatitis

The aim of the study was to assess efficacy and safety of newly developed specialized food product “SPP1” in patients with NASH. New specialized food product for clinical use (SPP1) consisted of (% of the RDAs): protein 8%; fat 7% (including ω-3 PUFA 40%); soluble dietary fiber 160%; phospholipids 25%; alpha-lipoic acid 33%; betaine 10%; minerals 13%–44%; vitamins (A, E, D3, K1, C, B1, B2, B6, B12, PP, Folic acid, Pantothenic acid, Biotin) 24%–140%. The study (NCT04308980) was approved by LEC and enrolled patients with diagnosis of NASH. Subjects were randomized to the following groups: those received iso-calorie diet (according to REE, by indirect calorimetry (Quarck RMR, Italy) alone (ICD) and iso-calorie diet + SPP1 (2 portions of SPP1 a day, 14 days)(ICD + SPP1 group). Safety was assessed based on clinical and laboratory data. Repeated measurements (baseline vs those on the 15th day of the study) of body composition (InBody, South Korea), and blood chemistry were compared. Non-parametric statistics (StatSoft, USA) was used for the analysis. The results of complex examination of 20 subjects (12 in ICD + SPP1 and 8 in ICD group) served as a source for the study. Initially, groups did not differ by age, sex, and BMI. The product was well tolerated. In contrast to ICD group, those in ICD + SPP1 group demonstrated greater decrease of weight: BMI initially (BMI0), Mean ± SD: 38.7 ± 5.4 kg/m2 vs BMI at the end-point (BMIEOT) 37.7 ± 5.1 kg/m2, P = 0.003 in ICD + SPP1 group, whereas in the ICD group BMI0 38.9 ± 7.2 kg/m2 vs BMIEOT 37.9 ± 7.3 kg/m2, P = 0.08. These results were reached predominantly by a decrease of the weight of fat: body fat weight (BFW)0 50.2 ± 10.7 kg vs BFWEOT 48.5 ± 10.8 kg, P = 0.002 in ICD + SPP1 group, whereas BFW0 48.9 ± 11.4 kg vs BFWEOT 46.8 ± 11.6 kg, P = 0.07 in ICD group. ALT and AST levels decreased in both groups, but in neither of them was statistically significant. The new specialized food product “SPP1” is safe, and well tolerated by patients with NASH. In combination with iso-calorie diet, it may increase efficacy of weight loss, predominantly by fat. Ministry of Science and Higher Education, #0529–2019-0055.