Effects of Phytosterol Supplementation on Liver Function and Inflammatory Status in Patients With Nonalcoholic Fatty Liver Disease

A randomized, double-blind, placebo-controlled, parallel experimental trial will be conducted to explore the therapeutic potential of phytosterol supplementation against NAFLD. Patients with NAFLD will be recruited from Jordan University Hospital, Department of Gastroenterology and Hepatology. Forty adult patients, males and females, aged less than 70, who are diagnosed with NAFLD by liver ultrasonography, and who are willing to participate will be invited to join the clinical trial and will be informed that they can leave the study whenever they want. Participants with any history of liver transplantation, tested positive for any type of hepatitis, autoimmune hepatitis, alcohol consumption, current corticosteroids or antibiotics consumption, rapid weight loss, heart failure, renal disease, pregnant and lactating women, patients with BMI higher than 40, or who have unintentional weight loss of 5%, and patients who are consuming other supplements within three months of the study will be excluded. A specialized physician will examine the patients, confirm the diagnosis, and ensure that all volunteers fit the inclusion criteria. The 40 patients will be randomly divided into two groups, using a random number generator at randomization.com; the phytosterols group (n=20), who will receive capsulated 2.0g oral phytosterol powder which will be consumed with meals daily, and the control group (n= 20) who will receive a placebo capsule (microcrystalline cellulose) of 2.0g daily. Each intervention will extend for two months, and the actual intervention phases will be preceded by a 2-week run-in period, in which the participants will be asked to refrain from the consumption of high stanols and sterols in their diets. For the entire duration of the study, patients will follow their habitual diets but will be advised to avoid high-fat foods, their physical activity will also be monitored and data on both dietary habits and physical activity will be assessed at baseline (week 0) and after the end of the study (week 8). All participants will be asked to come to the clinics every 2 weeks to collect their supplements and fill in the required questionnaires and supplement consumption checklist.