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IRCT20241014063363N1 IRCT 2025-04-10 Shiraz University Studying the the effects of Akkermansia Muciniphilia postbiotic , Lactobacillus rhamnosus postbiotic and green tea extract on overweight and obesity 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 2025-02-19 anticipated 108 Complete https://irct.ir/trial/80592 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 Overweight and obesity. Intervention 1: Intervention group1: Consume 3 capsules of Akkermansia muciniphila postbiotic supplement with count of 3×10˄10 cell count daily for 12 weeks. Intervention 2: Intervention group 2: Consume 3 capsules of Lactobacillus rhamnosus postbiotic supplement with count of 3×10˄10 cell count daily for 12 weeks. Intervention 3: Intervention group 3: Consume 3 capsules of Akkermansia muciniphila postbiotic and Lactobacillus rhamnosus supplement with count of 3×10˄10 cell count daily for 12 weeks. Intervention 4: Control group: Consume placebo daily 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 Sanaz Rowshanzadeh
Food science department- Agriculture collage- Bajgah
Shiraz Iran (Islamic Republic of) 71441-13131 +98 71 3613 8194 sanaz.rowshanzadeh@hafez.shirazu.ac.ir Shiraz University scientific Zahra Shrabi
Imam Reza clinic, Zand Street, Namazi square, Shiraz
shiraz Iran (Islamic Republic of) 7134814734 +98 71 3725 1002 zahra_2043@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Not obese or overweight (body mass index above 25 kg/m2) Not obese due to known hormonal disorders Not intolerant to IBS IBD neuropathy, gastroparesis and gastrointestinal motility disorder No thyroid disorders, diabetes, kidney disease, rheumatoid arthritis, or migraine No antibiotics for 2 months prior to study entry No nutritional supplements, prebiotics, probiotics, and omega-3 for one month prior to study entry No planning for pregnancy within the next 6 months and no breastfeeding No history of hospitalization, surgery, or bariatric surgery from 3 months before the study to 6 months after entering the study. No weight change of more than 6 kg in the past 3 months 20 years 50 years Both Planning for pregnancy for 6 months after the study Not having breast-feeding heavy alcohol use E66 Overweight and obesity Treatment - Other Treatment - Other Treatment - Other Treatment - Other Intervention group1: Consume 3 capsules of Akkermansia muciniphila postbiotic supplement with count of 3×10˄10 cell count daily for 12 weeks Intervention group 2: Consume 3 capsules of Lactobacillus rhamnosus postbiotic supplement with count of 3×10˄10 cell count daily for 12 weeks Intervention group 3: Consume 3 capsules of Akkermansia muciniphila postbiotic and Lactobacillus rhamnosus supplement with count of 3×10˄10 cell count daily for 12 weeks Control group: Consume placebo daily for 12 weeks Body weight. Timepoint: At the beginning of the study (before the intervention) and the end of study (12 weeks after the intervention). Method of measurement: Scale. Waist circumference. Timepoint: At the beginning of the study (before the intervention) and the end of study (12 weeks after the intervention). Method of measurement: Stadiometer. Percent of body fat. Timepoint: At the beginning of the study (before the intervention) and the end of study (12 weeks after the intervention). Method of measurement: Body composition analyzer. Lipopolysacchride (LPS). Timepoint: At the beginning of the study (before the intervention) and the end of study (12 weeks after the intervention). Method of measurement: Enzyme-linked immuno-sorbent (ELISA) assay. High- sensitivity C-reactive Protein (hs-CRP). Timepoint: At the beginning of the study (before the intervention) and the end of study (12 weeks after the intervention). Method of measurement: Enzyme-linked immuno-sorbent (ELISA) assay. Interleukin 6 (IL-6). Timepoint: At the beginning of the study (before the intervention) and the end of study (12 weeks after the intervention). Method of measurement: Enzyme-linked immuno-sorbent (ELISA) assay. Interleukin 1-B (IL-1 B). Timepoint: At the beginning of the study (before the intervention) and the end of study (12 weeks after the intervention). Method of measurement: Enzyme-linked immuno-sorbent (ELISA) assay. Leptin. Timepoint: At the beginning of the study (before the intervention) and the end of study (12 weeks after the intervention). Method of measurement: Enzyme-linked immuno-sorbent (ELISA) assay. GLP-1. Timepoint: At the beginning of the study (before the intervention) and the end of study (12 weeks after the intervention). Method of measurement: Enzyme-linked immuno-sorbent (ELISA) assay. Waist to hip ratio. Timepoint: At the beginning of the study (before the intervention) and the end of study (12 weeks after the intervention). Method of measurement: Flexible meter. Visceral body fat. Timepoint: At the beginning of the study (before the intervention) and the end of study (12 weeks after the intervention). Method of measurement: Body composition analyzer. Lean body mass. Timepoint: At the beginning of the study (before the intervention) and the end of study (12 weeks after the intervention). Method of measurement: Body composition analyzer. Malondialdehyde (MDA). Timepoint: At the beginning of the study (before the intervention) and the end of study (12 weeks after the intervention). Method of measurement: Spectrophotometry. Total antioxidant capacity (TAC). Timepoint: At the beginning of the study (before the intervention) and the end of study (12 weeks after the intervention). Method of measurement: Colorimetric method. Waist circumference to height. Timepoint: At the beginning of the study (before the intervention) and the end of study (12 weeks after the intervention). Method of measurement: Flexible meter. Appetite score. Timepoint: At the beginning of the study (before the intervention) and the end of study (12 weeks after the intervention). Method of measurement: VAS questionnaire. Depression score. Timepoint: At the beginning of the study (before the intervention) and the end of study (12 weeks after the intervention). Method of measurement: Beck questionnaire. Triglyceride. Timepoint: At the beginning of the study (before the intervention) and the end of study (12 weeks after the intervention). Method of measurement: Colorimetric method. Total cholesterol. Timepoint: At the beginning of the study (before the intervention) and the end of study (12 weeks after the intervention). Method of measurement: Colorimetric method. LDL (Low- density lipoprotein). Timepoint: At the beginning of the study (before the intervention) and the end of study (12 weeks after the intervention). Method of measurement: Colorimetric method. HDL (High- density lipoprotein). Timepoint: At the beginning of the study (before the intervention) and the end of study (12 weeks after the intervention). Method of measurement: Colorimetric method. Fasting blood sugar (FBS). Timepoint: At the beginning of the study (before the intervention) and the end of study (12 weeks after the intervention). Method of measurement: Colorimetric method. Aspartate transaminase (AST). Timepoint: At the beginning of the study (before the intervention) and the end of study (12 weeks after the intervention). Method of measurement: Colorimetric method. Physical activity. Timepoint: At the beginning of the study (before the intervention) and the end of study (12 weeks after the intervention). Method of measurement: met questionnaire. Food intake. Timepoint: At the beginning of the study (before the intervention) and the end of study (12 weeks after the intervention). Method of measurement: 24- hour dietary recall (24hr). Alanine transaminase (ALT). Timepoint: At the beginning of the study (before the intervention) and the end of study (12 weeks after the intervention). Method of measurement: Colorimetric method. Adiponectin. Timepoint: At the beginning of the study (before the intervention) and the end of study (12 weeks after the intervention). Method of measurement: Enzyme-linked immuno-sorbent (ELISA) assay. Research contract Approved 2025-02-26 Research Ethics Committees of Schools of Health and Nutrition-Shiraz University of Medical Sciences School of Health and Nutrition, Razi Blvd., Shiraz Shiraz Fars Iran (Islamic Republic of)