Clinical trial: a nutritional supplement Viusid, in combination with diet and exercise, in patients with nonalcoholic fatty liver disease

Randomized 1:1 clinical trial in adults with histologically confirmed nonalcoholic fatty liver disease/steatohepatitis at the National Institute of Gastroenterology in Havana, Cuba. The active Viusid arm included 30 participants; enrollment occurred in February to March 2007.

Viusid was given orally as three 50 g sachets daily for 24 weeks, alongside a hypocaloric diet and aerobic exercise. The comparator received diet and exercise alone.

Viusid plus lifestyle modification produced greater histologic improvement than lifestyle change alone, especially for the nonalcoholic activity score and key steatosis-related features. NAS improved from 4.18 to 0.54 in the Viusid arm versus 4.45 to 2.2 in controls, with a between-group P value < 0.001; between-group differences also favored Viusid for steatosis (P < 0.001), ballooning (P = 0.002), and lobular inflammation (P = 0.025), while fibrosis was not significantly different (P = 0.07). ALT and AST improved in both groups without a significant between-group difference. Viusid also reduced uric acid, triglycerides, weight, waist circumference, insulin, and HOMA-IR, and it was well tolerated, with nausea and diarrhea reported in one participant.

This was a small, single-center trial with only 24 weeks of follow-up, which limits precision and long-term inference. Benefits were observed in the setting of concurrent diet and exercise, so the incremental effect of Viusid may be context dependent. Fibrosis did not improve significantly, and generalizability beyond this Cuban NAFLD population is limited.