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

Determining the effect of multistrain synbiotic supplementation on insulin resistance, liver enzyme, inflammatory and anthropometric indices in overweight and obese adults with co-morbidities of diabetes and fatty liver

This study is a clinical control trial, parallel groups, triple-blind, randomized, phase 3, on 40 participants (20 people in the intervention group and 20 people in the control group).

Patients with fatty liver and diabetes referred to Motahari Clinic in Shiraz after obtaining informed consent and evaluating and confirming the conditions for entering the study, blood samples will be taken from and background information will be recorded. Then, according to the randomization sequence, they will be divided into one of the intervention or control groups and receive synbiotic supplement or placebo along with diet for 12 weeks. After the end of the intervention period, the patients return to the clinic for final tests. The research team and participants were blinded regarding the allocation of subjects to control or intervention groups.

Inclusion criteria: Having fatty liver (grade 2 or 3). Having diabetes and prediabetes (fasting blood sugar above 100). Being overweight or obese (BMI greater than 25) Exclusion criteria: Taking antibiotics or probiotic supplements in the 3 months before the study. Pregnancy or breastfeeding. Insulin use

The participants in the intervention group receive a multi-strain synbiotic supplement along with a weight loss diet. The participants in the control group also receive a weight loss diet along with a placebo.

Aspartate Aminotransferase

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.

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.