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IRCT20240212060977N1 IRCT 2024-02-20 Shiraz University of Medical Sciences The effect of synbiotic supplementation in the treatment of fatty liver Investigating the effect of multi-strain synbiotic supplementation on insulin resistance, liver enzymes, inflammatory, and anthropometric indices in diabetic, obese, and overweight patients with non-alcoholic fatty liver disease 2024-04-13 anticipated 40 Complete https://irct.ir/trial/75535 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done using the random block method (1:1 ratio) for two groups (a control group and an intervention group). In this method, double blocks with rotation period will be created by a person outside the study. Then, a block is randomly selected to determine the groups assigned to the first two participants. The random block selection process is repeated to determine the random assignment sequence for the entire sample size. In order to hide the allocation, after determining the random sequence, these sequences named A and B are placed in sealed opaque envelopes for each participant. A person outside the study familiar with randomization will perform this process. During the study, as each participant enters the study, based on the order, an envelope is opened and the assigned group is determined, Blinding description: Study groups and supplements will be labeled as A and B by an out-of-study person to blind the research team and participants. This naming will remain confidential until the end of the study. Supplements and placebos and their packaging are similar in appearance, size, color, and odor. 3 Condition 1: Fatty Liver. Condition 2: Type 2 diabetes mellitus. Intervention 1: Intervention group: The intervention in this group includes receiving a synbiotic supplement (produced by Zist Takhmir Company) containing one billion CFU in each capsule of strains of Lactobacillus casei, Lactobacillus rhamnosus, Lactobacillus acidophilus, Bifidobacterium Bruhe, Bifidobacterium lactis, Bifidobacterium longum along with a weight loss diet. One daily supplement is taken after meal for 12 weeks. Intervention 2: Control group: The participants in this group take a placebo (from Zist Takhmir company) after meal, along with the weight loss diet for 12 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Aryan Mohammad Yazdani
School of Nutrition and Food Sciences, Razi Blvd., Shiraz
Shiraz Iran (Islamic Republic of) 7153675500 +98 71 3725 1001 Yazdani.2000.a@gmail.com Shiraz University of Medical Sciences scientific Mohammad Hassan Eftekhari
School of Nutrition and Food Sciences, Razi Blvd., Shiraz
Shiraz Iran (Islamic Republic of) 7153675500 +98 71 3725 1001 h_eftekhari@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Having fatty liver (grade 2 or 3) Having diabetes or prediabetes (fasting blood sugar above 100) Being overweight or obese (BMI greater than 25) Aged 18 or higher from both male and female genders Not taking insulin Not being pregnant or breastfeeding Not suffering from certain diseases, including metabolic, respiratory, and kidney diseases Not taking antibiotics or probiotic or synbiotic supplements in the 3 months before the study 18 years 65 years Both Suffering from certain diseases during study, including respiratory and kidney diseases Taking multivitamins while studying Consumption of less than 80% of prescribed supplements Consumption of other probiotics during the study The need to take antibiotics Getting pregnant Requiring need for insulin K76.0 E11 Fatty (change of) liver, not elsewhere classified Type 2 diabetes mellitus Treatment - Other Placebo Intervention group: The intervention in this group includes receiving a synbiotic supplement (produced by Zist Takhmir Company) containing one billion CFU in each capsule of strains of Lactobacillus casei, Lactobacillus rhamnosus, Lactobacillus acidophilus, Bifidobacterium Bruhe, Bifidobacterium lactis, Bifidobacterium longum along with a weight loss diet. One daily supplement is taken after meal for 12 weeks. Control group: The participants in this group take a placebo (from Zist Takhmir company) after meal, along with the weight loss diet for 12 weeks. Aspartate Aminotransferase. Timepoint: Before the start of the intervention and after the end of the intervention. Method of measurement: Standard enzymatic method. Alanine aminotransferase. Timepoint: Before the start of the intervention and after the end of the intervention. Method of measurement: Standard enzymatic method. Fasting blood sugar. Timepoint: Before the start of the intervention and after the end of the intervention. Method of measurement: Standard enzymatic method. Triglyceride. Timepoint: Before the start of the intervention and after the end of the intervention. Method of measurement: Standard enzymatic method. Total cholestrol. Timepoint: Before the start of the intervention and after the end of the intervention. Method of measurement: Standard enzymatic method. Total antioxidant capacity. Timepoint: Before the start of the intervention and after the end of the intervention. Method of measurement: Standard enzymatic method. Low-density lipoprotein. Timepoint: Before the start of the intervention and after the end of the intervention. Method of measurement: Standard enzymatic method. High-density lipoprotein. Timepoint: Before the start of the intervention and after the end of the intervention. Method of measurement: Standard enzymatic method. C-reactive protein. Timepoint: Before the start of the intervention and after the end of the intervention. Method of measurement: ELISA method. Alkaline Phosphates. Timepoint: Before the start of the intervention and after the end of the intervention. Method of measurement: Standard enzymatic method. Glycated hemoglobin. Timepoint: Before the start of the intervention and after the end of the intervention. Method of measurement: Standard enzymatic method. Fasting insulin. Timepoint: Before the start of the intervention and after the end of the intervention. Method of measurement: ELISA method. Shiraz University of Medical Sciences Approved 2024-02-12 Research Ethics Committees of Schools of Health and Nutrition - Shiraz University of Medical Science 5th floor, Shiraz University Central Building, Islamic Republic Boulevard, Shiraz Shiraz Fars Iran (Islamic Republic of)