The effect of Synbiotic on reducing insulin resistance in overweight or obese children

Determining the effect of synbiotics on reducing insulin resistance in overweight or obese children

A clinical trial with parallel groups, double-blinded, randomized (permuted block randomization), phase 3 on 40 children with obesity/overweight, using www.sealedenvelope.com for randomization.

This study is performed in Ali Asghar Children's Hospital. Obese or overweight children are randomly assigned into two groups. In the first group, children receive Synbiotic. In the second group, children receive placebo. In this study, children and physicians did not know the type of medication they received.

Inclusion criteria: Age range between 4 -18 years, Obese or overweight children: Obese children, children with a BMI of more than 95% and overweight children, children with a BMI between 85-95%, Children with insulin resistance (HOMA-IR : > 2.5 = Positive for IR) Exclusion criteria: Children who developed obesity following syndromic disorder or endocrine disorders, Physical disability, Taking corticosteroids, Treated with metformin, Under special treatment or diet, Acute pancreatitis, History of allergies.

In the intervention group, Children receive 1 sachet of probiotic daily (Kidi Lact, manufactured by Zist Takhmir Company, Iran) for 8 weeks. in the Control group: Children received one placebo sachet (manufactured by Zist Takhmir Company, Iran) daily for 8 weeks.

Insulin Resistance level

In this study, the block randomization method is used with blocks of sizes six and four. The website https://www.sealedenvelope.com is used to create a randomization sequence. Each random sequence generated contains a unique code for concealment. The drug regimen is placed in envelopes according to random sequence, and after sealing it on the envelopes, the specific number created by the site is written and the envelopes are randomly placed in a box.

This study is double-blinded: both the patient and the doctor are unaware of the type of medication. Method of blinding patients: Synbiotic supplement is in the form of sachets, placebo sachets are exactly similar to the appearance, taste and smell of Kidi Lact and (produced by Zist Takhmir Company). Physician blinding method: sealed envelopes created by the Company are provided to a researcher who does not interfere in choosing the type of drug. After entering the study and collecting their baseline information from the physician, the individuals send them to the researcher to get the medicine, and the researcher will give one of the envelopes to the patients, and then in the sheet that is kept with the researcher, it is specified that What medicine has each patient taken.