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IRCT20230522058257N1 IRCT 2023-11-04 Shiraz University of Medical Sciences Comparing the effects of yogurt containing Akkermansia Muciniphilia postbiotic with yogurt containing Lactobacillus Rhamnosus postbiotic on body composition, anthropometric and biochemical indices, appetite, and depression scores in overweight or obese adults Comparing the effects of yogurt containing Akkermansia Muciniphilia postbiotic with yogurt containing Lactobacillus Rhamnosus postbiotic on body composition, anthropometric and biochemical indices, appetite, and depression scores in overweight or obese adults: a Randomized, double-blind, controlled clinical trial 2023-09-23 anticipated 66 Complete https://irct.ir/trial/70351 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 three groups (one control and two intervention groups). In this method, blocks of three 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 three 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 opaqued envelopes for each participant. An out-of-study person familiar with randomization will perform this process. During the study, by entering any participant in the study, based on the sequence, an envelope will be opened and the allocated group will be revealed, Blinding description: In this study, for blinding the interventions, enriched yogurts (including two types of yogurts) and placebo are the same in terms of color, odor, and taste and will be named A, B, and C. The process of filling yogurt containers and naming them will be done by an out-of-study person. Therefore, in this study, the research 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 group 1: consume 120 cc of yogurt containing 10^10 TFU Ackermansia muciniphila postbiotic befor meal daily for 8 weeks. Intervention 2: Intervention group 2: consume 120 cc of yogurt containing 10^10 TFU Lactobacillus Rhamnosus postbiotic befor meal daily for 8 weeks. Intervention 3: Control group: consume 120 cc of low fat yogurt befor meal daily for 8 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 Erfaneh Aalipanah
School of Nutrition and Food Sciences, Razi Blvd., Shiraz
Shiraz Iran (Islamic Republic of) 7134814336 +98 71 3725 8099 E.Aalipanah71@gmail.com Shiraz University of Medical Sciences scientific Zahra Sohrabi
School of Nutrition and Food Sciences, Razi Blvd., Shiraz
Shiraz Iran (Islamic Republic of) 7134814336 +98 71 3725 8099 zahra_2043@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Aged 20 - 50 years and not being menopause for females Being overweight or obese (Body mass index higher than 25) Not allergic to milk protein and Not lactose intolerant,not being gluten-intolerant Not suffering from known endocrine-related obesity, Inflammatory bowel disease, Irritable bowel syndrome, nouropathy, gastroparesis and gastrointestinal disorders at the beginning of the study Not suffering from thyroid diseases, diabetes, kidney disease, rheumatic diseases and migraine headache at the baseline did not use antibiotics for 2 months before the beginning of the study didn't take probiotic, prebiotic, and omega 3 supplements for 1month before the study Not taking part in other studies for 6 months before the study No weight reduction over 6 Kg in the last 3 months prior to the study no history of hospitalization or any surgery and bariateric surgery for 3 months before the study and 6 months after entering the study Not following special diets such as vegetarian or gluten free or weight-reducing diets Not infected with Covid-19 or any other infections or any hospitalization for 1 month before the study 20 years 50 years Both planning for pregnancy for 6 months after the study and not having breast-feeding heavy alcohol use E66 Overweight and obesity Treatment - Other Treatment - Other Treatment - Other Intervention group 1: consume 120 cc of yogurt containing 10^10 TFU Ackermansia muciniphila postbiotic befor meal daily for 8 weeks. Intervention group 2: consume 120 cc of yogurt containing 10^10 TFU Lactobacillus Rhamnosus postbiotic befor meal daily for 8 weeks. Control group: consume 120 cc of low fat yogurt befor meal daily for 8 weeks. Waist circumference. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: stadiometer. Body weight. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: scale. Body mass index. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: By calculating using the formula with using height and weight. Percent of body fat. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Body composition analyzer. Lipopolysaccharide (LPS). Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Enzyme-linked immuno_sorbent assay (ELISA) kit. High-sensitivity C-reactive Protein (hs-CRP) blood level. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Enzyme-linked immuno_sorbent assay (ELISA) kit. Visceral body fat. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 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 the study (8 weeks after the intervention). Method of measurement: Body composition analyzer. Waist to hip ratio. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: flexible meter. Malondialdehyde (MDA). Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: spectrophotometry. Appetite score. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 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 the study (8 weeks after the intervention). Method of measurement: beck questionnaire. Total antioxidant capacity (TAC). Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 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 the study (8 weeks after the intervention). Method of measurement: flexible meter. Triglyceride. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: colorimetric method. Total cholestrol. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 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 the study (8 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 the study (8 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 the study (8 weeks after the intervention). Method of measurement: colorimetric method. Alanine transaminase (ALT). Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 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 the study (8 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 the study (8 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 the study (8 weeks after the intervention). Method of measurement: 24-hour dietary recall (24hr). Shiraz University of Medical Sciences Approved 2023-05-21 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)