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IRCT20131022015111N3 IRCT 2018-02-18 Kermanshah University of Medical Sciences Effect of probiotic yogurt fortified with vitamin D on fatty liver 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 2017-10-23 anticipated 90 Complete https://irct.ir/trial/28809 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Individual Randomization - Using Random Number Tables, Blinding description: - 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. 3 fatty liver. Intervention 1: Intervention group: Riched yogurt (100 cc/day) with 1000 IU vitamin D and 40000000 cfu Probiotic. Intervention 2: Control group: Plain yogurt (100 cc/day) receiving group. No - There is not a plan to make this available Justification or reason for not sharing IPD is Trials that began to sample collection on January 11, 2018 should have a release plan when registering their study protocol
public Mojgan Morvaridzadeh
Nutrition and Food Sciences Faculty, Next to the Farabi Hospital, Dolat Abad Blvd, Isar Square, Imam Hosein Exp,
Kermanshah Iran (Islamic Republic of) 6719851351 +98 83 3723 3221 morvaridzadehm@yahoo.com Kermanshah University of Medical Sciences scientific Seyed Mostafa Nachvak
Nutrition and Food Sciences Faculty, Next to the Farabi Hospital, Dolat Abad Blvd, Isar Square, Imam Hosein Exp,
Kermanshah Iran (Islamic Republic of) 6719851351 +98 83388264165 Smnachvak@hotmail.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) 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 have full satisfaction to participate 25 years 55 years Both individuals who use any kind of drug individuals who has allergic to yogurt individuals who are suffering from other chronic diseases like: cardio vascular diseases, kidney diseases, thyroid and... individuals who are suffering from other chronic diseases like: any kind of hepatitis, cirrhosis and ... 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 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. Women who are pregnant, lactating or menopause. individuals who use cigarettes and alcohol. K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Other Placebo Intervention group: Riched yogurt (100 cc/day) with 1000 IU vitamin D and 40000000 cfu Probiotic Control group: Plain yogurt (100 cc/day) receiving group Alanine Aminotransferase. Timepoint: Before and 3 month after intervention. Method of measurement: by using Kit. Aspartate Aminotransferase. Timepoint: Before and 3 month after intervention. Method of measurement: by using Kit. Total Cholesterol. Timepoint: Before and 3 month after intervention. Method of measurement: By using Kit. Trigliceride. Timepoint: Before and 3 month after intervention. Method of measurement: By using Kit. Low-density lipoprotein. Timepoint: Before and 3 month after intervention. Method of measurement: By using Kit. High-density lipoprotein. Timepoint: Before and 3 month after intervention. Method of measurement: By using Kit. Fast Blood Sugar. Timepoint: Before and 3 month after intervention. Method of measurement: By using Kit. Serum Insulin. Timepoint: Before and 3 month after intervention. Method of measurement: Insulin MONOBIND Kit. Weight. Timepoint: Before and 3 month after intervention. Method of measurement: scale. Abdomen Circumference. Timepoint: Before and 3 month after intervention. Method of measurement: Tape measure. Hip Circumference. Timepoint: Before and 3 month after intervention. Method of measurement: Tape measure. Body Fat Percentage. Timepoint: Before and 3 month after intervention. Method of measurement: Body Analyzer Machine. Body Muscle Percentage. Timepoint: Before and 3 month after intervention. Method of measurement: Body Analyzer Machine. Vitamin D. Timepoint: Before and 3 month after intervention. Method of measurement: By using Kit. Kermanshah University of Medical Sciences Approved 2018-01-03 Ethics Committee of Kermanshah University of Medical Sciences Ethics Committee, Building No 2 of Kermanshah University of Medical Sciences, Naft Square, Shahid Beheshti Blvd Kermanshah Kermanshah Iran (Islamic Republic of)