Comparing the effects of Akkermansia muciniphilia postbiotic , Lactobacillus rhamnosus postbiotic and green tea extract on body composition, anthropometric and biochemical indices, appetite, and depression scores in overweight or obese adults: a Randomized, double-blind, controlled clinical trial

Comparing the effect of capsule containing Akkermansia muciniphila postbiotic Lactobacillus rhamnosus postbiotic and green tea extracts on body composition, anthropometric and biochemical indices in obese and overweight adults

This study is a randomized, double- blinded, phase 3 controlled clinical trial with four parallel groups (3 intervention and one control groups). 108 individuals (27 in each group) were randomized into groups with balanced- blocked randomization.

108 eligible individuals referred to Imam Reza clinic, after becoming informed and obtaining informed consent, are randomly assigned into 4 study groups. They receive group samples, which are named the same as the groups with the letters A, B, C and D to blind the participant and the researcher and they take it daily before meals for 12 weeks. Body composition, anthropometric and biochemical indices and appetite and depression scores will be assessed before and after the study

Inclusion criteria: • Overweight or obese age 20 to 50 years • Not being menopause for females •Not suffering from metabolic, endocrine, chronic diseases or any kind of infection •Not hospitalized, did not use antibiotics, probiotic or prebiotic supplements or any medication for 3 months before the study Exclusion criteria: • Pregnancy and lactation

The study groups, including intervention and control groups, included the first group, which included postbiotic Akkremancia muciniphila and green tea extract, the second group, which included postbiotic Lactobacillus rhamnosus and green tea extract, the third group, which included postbiotics and green tea , and the fourth group, which included the control group. The control group was used capsules containing fillers such as Avicel or croscarmellose.

Body weight, WC, BMI

Randomization will perform using the random block method (1:1:1 ratio) for four groups (one control and three intervention groups). In this method, blocks of four with rotation will be created by an out-of-study person. Then, a block will be randomly selected to determine the groups assigned to the first four participants. The random- blocks selection process will be repeated to determine the random allocation for the entire sample size. For allocation concealment, after determining the random sequence, these sequences will be placed in numbered sealed opaque envelopes for each participant. An out of study person familiar with randomization will perform this process. During the study, by entering any participant in this study, based on the sequence, an envelope will be opened and the allocated group will be revealed.

In this study, for building the intervention, supplements (including three types) and placebo are the same in terms of color and odor of capsules and will be named A, B, C and D. The process of producing capsules and naming them will be done by an out-of -study person. Therefore, in this study, the researcher team and the participants of different groups will be blinded to the type of the interventions or placebo consumed by each participant in order to observe the principles of blinding.