Effects of probiotic yogurt fortified with vitamin D in comparison to conventional yogurt on hepatic enzymes, lipid profile, glycemic and anthropometric indices in patients with non-alcoholic fatty liver disease

1- Comparison of changes in liver enzymes (ALT, AST) before and after consumption of vitamin D fortified probiotic yogurt or simple yogurt in patients with non-alcoholic fatty liver disease 2- Comparison of changes in lipid profile (HDL, LDL, Tchol, TG) before and after consumption of vitamin D fortified probiotic yogurt or simple yogurt in patients with non-alcoholic fatty liver disease 3- Comparison of changes in glycemic indexes (Insulin and FBS) before and after consumption of vitamin D fortified probiotic yogurt or simple yogurt in patients with non-alcoholic fatty liver disease 4- Comparison of changes in anthropometric indices (weight, abdomen circumference, hip circumference, abdomen to hip ratio) before and after consumption of vitamin D fortified probiotic yogurt or simple yogurt in patients with non-alcoholic fatty liver disease

In this research, 90 patients with grade 1 or 2 fatty liver, who are eligible to enter the study, referred from the ultrasound clinic, are selected. The participants will be randomly assigned to two 45-member groups including the control group (receiving conventional yogurt 100 gr per day) and the intervention group (receiving probiotic yogurt enriched with vitamin D, 100 gr per day). Randomization will be done using the random numbers table and will receive the relevant code. This trial is a double blind randomized clinical trial.

This study will be conducted at Kermanshah Nutrition and food Sciences Faculty. Individuals will complete consent form, demographic information and physical activity questionnaire. The weight, height, and body composition are determined using the body analyzer. The fasting blood sample will also be taken about 10 cc. In this study the factory will use two different codes for 2 kinds of yogurt instead of their names to make blinding possible. Therefore the patients, the main presenter, the data collectors, the yogurt distributors, as well as the persons who analysis the data, will be blind from the beginning to the end of the study.

Inclusion criteria: individuals with new diagnosed fatty liver disease; individuals with grade 1 or 2 fatty liver disease; individuals with the age of 25 to 55 years old; individuals who are completely content. Non-inclusion criteria: individuals who use any kind of medication; individuals who are allergic to yogurt; individuals who are suffering from other chronic diseases like cardio vascular diseases, kidney diseases, thyroid diseases, any kind of hepatitis, cirrhosis or had liver transplant; individuals who had a background of cancer; women who use contraceptive drugs; individuals who use certain regimens or weight loss regimens; individuals who use any vitamin supplements; individuals who use any kind of probiotic supplement or probiotic food products; individuals who take any antioxidant supplements; individuals who have taken any type of fiber containing supplement or omega 3 supplement during 6 weeks before starting the study; individuals who have taken antibiotics over the 2 weeks before starting the study; pregnancy; breast feeding; menopause; cigarette smoking; alcohol use

The control group includes people who will receive simple yogurt and in the intervention group, the participants will receive yogurt with vitamin D and probiotics.

Changes in liver enzymes; lipid profile; glycemic and anthropometric indices

Individual Randomization - Using Random Number Tables

- The appearance of yogurt is the same for both participants in both groups. - Ultrasound specialist will not be aware of the group of individuals. - The main investigator will not be aware of the content of yogurts and also of the group which they are in. - The staff of collecting information, the yogurt providers and also description providers will also be unaware of the content of yogurt and the group of participants. - persons who analyzing data will be unaware of the kind of group which each person belong.

Trials that began to sample collection on January 11, 2018 should have a release plan when registering their study protocol