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IRCT20231231060581N1 IRCT 2024-01-08 Shiraz University of Medical Sciences Investigating the effect of probiotics and exercise in patients after bariatric surgery The effect of probiotic yogurt and exercise on the muscle mass, muscle strength, anthropometry and biochemical parameters and depression score in post-bariatric surgery patients 2024-02-20 anticipated 52 Complete https://irct.ir/trial/74742 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will perform using the random block method (1: 1: 1:1 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 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 and placebo are the same in terms of color, odor, and taste and will be named A and B. 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. For the exercise intervention group, the program is designed individually and home-based and the participants are not aware about each other's intervention. N/A obesity, bariatric surgery. Intervention 1: Intervention group: Receiving 120 cc of low-fat yogurt containing Bacillus coagulans + Lactobacillus plantarum probiotics in the amount of 1010 bacteria per day for 12 weeks along with a resistance training program. Intervention 2: Intervention group: Receiving 120 cc of yogurt containing the desired probiotics for a period of 12 weeks. Intervention 3: Intervention group: Receive 120 cc of plain low-fat yogurt for 12 weeks along with a resistance training program. Intervention 4: Control group: Receive 120 cc of plain low-fat yogurt 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 Shirin Rajabi
School of Nutrition and Food Sciences, Razi Blvd., Shiraz
shiraz Iran (Islamic Republic of) 7134814336 +98 71 3725 8099 shirin_r69@yahoo.com Shiraz University of Medical Sciences scientific siavash babajafari
School of Nutrition and Food Sciences, Razi Blvd., Shiraz
shiraz Iran (Islamic Republic of) 7134814336 +98 71 3725 8099 jafaris@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) post-bariatric surgery patients Age above 18 18 years no limit Both Having cardiovascular disorders, systolic or diastolic blood pressure, uncontrolled metabolic disorders, neuromuscular or rheumatological disorders, acute pulmonary embolism, chronic symptomatic heart failure, mental or physical disabilities Sensitivity to milk protein and lactose Sensitivity to gluten Taking prebiotics and probiotics since 1 month before entering the study E66 Overweight and obesity Treatment - Other Treatment - Other Treatment - Other Treatment - Other Intervention group: Receiving 120 cc of low-fat yogurt containing Bacillus coagulans + Lactobacillus plantarum probiotics in the amount of 1010 bacteria per day for 12 weeks along with a resistance training program Intervention group: Receiving 120 cc of yogurt containing the desired probiotics for a period of 12 weeks Intervention group: Receive 120 cc of plain low-fat yogurt for 12 weeks along with a resistance training program Control group: Receive 120 cc of plain low-fat yogurt for 12 weeks Muscle 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 Analyzer. Muscle strength. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: handgrip, sit to stand test. 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. BMI. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: formula. Body fat percent. 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 analyzer. 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: flexible meter. Hip 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: flexible meter. Waist/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: formula. Waist/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: formula. 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. GGT(Gammaglutamyl transferase). 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. 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. Insulin. 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. Cortisol. 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. Hs-CRP(C-reactive Protein). 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. Adiponectin. 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. Vitamin d3. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: HPLC. 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: questionnaire. Shiraz University of Medical Sciences Approved 2023-12-31 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)