Comparison of Non-invasive Methods in Assessing Combined Effects of Flaxseed Supplements and Intermittent Fasting Diets on Liver Fibrosis in Patients with Non-alcoholic Fatty Liver: A Randomized Clinical Trial Study

Nonalcoholic fatty liver disease is known as a chronic liver disease, whose prevalence is increasing worldwide and if not treated can lead to hepatic cirrhosis and fibrosis. The gold standard for diagnosing non-alcoholic fatty liver disease and assessing the extent of liver fibrosis is liver biopsy; however, this is an invasive method that can lead to possible side effects. Therefore, use of non-invasive methods is suggested. The aim of this study was to assess effects of intermittent fasting and flaxseed consumption on liver fibrosis through non-invasive marker panel and Fibroscan in patients with non-alcoholic fatty liver disease.

Methods and Materials: 

Changes in liver fibrosis in fifty patients with non-alcoholic fatty liver disease were investigated using intermittent fasting diet with daily consumption of 30 g of flaxseed supplement in a randomized clinical trial. At the beginning and at the end of the study, height and weight of the participants were measured. Body mass index, physical activity questionnaire (physical activity using the international physical activity questionnaire) and 24-h recall were completed by the patients at the beginning and the end of the study. Approximate duration of the study was 12 w. Hepatic fibrosis assessment methods that used at the beginning and the end of the study included Fibroscan and calculation of non-invasive marker panel, such as fibrosis 4 (FIB-4), AST aminotransferase platelet ratio index (APRI) and body mass index, AST/ALT aminotransferase ratio, Diabetes (BARD).

In general, 45 patients with nonalcoholic fatty liver disease with an average age of 46.83 years old and an average BMI of 32.79 kg/m2 were included in the analysis. Results of this study showed that following diets with supplements, hepatic fibrosis score decreased using Fibroscan assay (p = 0.507), BARD (p = 0.396), FIB-4 (p = 0.984) and APRI (p = 0.682); however, none of them were statistically significant after 12 w, compared to the control group.

Results of Fibroscan and BARD, FIB-4 and APRI indices were similar in assessing liver fibrosis changes after the intervention. Future studies with larger sample sizes are needed to verify these results.