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IRCT20170202032367N6 IRCT 2022-07-17 Tehran University of Medical Sciences The effect of a new developed synbiotic yogurt consumption in adults with metabolic syndrome Effects of Daily Low-Fat Synbiotic Yogurt Consumption on Metabolic Parameters, Inflammatory Biomarkers, and Gene Expression Related to Inflammation and Lipid in Adults with Metabolic Syndrome 2022-07-23 anticipated 44 Complete https://irct.ir/trial/63976 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: First, we will use the Stratified Permuted Block Randomization method for patients who meet the inclusion criteria for random distribution in the intervention and control groups. First, they are classified in terms of gender (male/female) and body mass index level (from 25–29.9 and 35–30) and are placed in double blocks using the randomization method with sizes 2 and 4 (from the special table). used for randomization). Accordingly, each person may have four states. Then, people with the same conditions are randomly divided into intervention and control groups. In order to randomly assign both people to one of the groups, each person will be given a code, and these codes will be poured into a pot. An out-of-study person will then be asked to draw the codes out of the pot using a lottery. The person with the first code issued will be assigned to the intervention group and the other person to the control group. This process will be done in the same way for both people with the same condition, Blinding description: Patients enrolled in this study will be unaware of whether they are in the normal yogurt group or in the synbiotic yogurt group. On the other hand, due to the similarity of the appearance of both products, which are given to the participants in packages with the same appearance and the same label, an attempt has been made to blind the patients. Also other people who participate in other stages including the researchers , the outcome evaluators, the analysts are blind to the study, and the third independent person is responsible for prescribing and secretly recording our type of prescription, and the other person is responsible for collecting data. The data analyzer also announces the results according to groups A and B. The drug evaluator also does not know the type of yogurt prescribed for each patient. 3 Metabolic syndrome. Intervention 1: Intervention group: Will receive 300 g/day of synbiotic yogurt containing Lactobacillus Plantarum, Lactobacillus pentosus (2˟108 CFU), and Kluyveromyces marxianus and 3% of various natural plants (mountain celery, shallot, chicory, and mint) made by Yasuj Pasteurized Milk Company for 12 weeks. Intervention 2: Control group: Will receive 300 g/day of regular yogurt made by Yasuj Pasteurized Milk Company for 12 weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to confidentiality of participant information, it is not possible to publish it
public Hossien Imani
No. 44, Shahid Hojjat Doost Alley, Naderi St, Keshavarz Boulevard
Tehran Iran (Islamic Republic of) 1416643931 +9821889900285 h_imani@sina.tums.ac.ir Tehran University of Medical Sciences scientific Hossein Imani
No. 44, Shahid Hojatost Alley, Keshavarz Boulevard, Naderi St
Tehran Iran (Islamic Republic of) 1416643931 +98 21 8899 0285 h-imani@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Age between 30 and 50 years old Body mass index (BMI) ranged from 25 to 35 kg/m2 The presence of at least three of the five components of the metabolic syndrome according to the ATP III criteria including waist circumference greater than 102 cm in men and 88 cm in women, triglyceride equal to or greater than 150 mg/dL, HDL less than or equal to 40 in men and less than or equal to 50 In women, blood pressure equal to or greater than 130/85 mmHg and blood sugar equal to or greater than 100 mg/dL Willingness to participate in the study 30 years 50 years Both Participate in weight loss programs over the past six months Weight change of more than 10% in the last six months Professional athletes or changes in the intensity and level of physical activity during the last four weeks Pregnant, lactating and postmenopausal women Allergy to dairy products and probiotics Smoking and alcohol consumption Routine consumption of products containing probiotics or synbiotics Diagnosed cardiovascular, kidney, gastrointestinal, endocrine, pulmonary, neurological, and autoimmune diseases; diabetes; thyroid dysfunction; cancer; and eating disorders. Taking medications that could affect appetite, body weight, and lipid metabolism or have anti-inflammatory effects such as corticosteroids, oral contraceptives, antidepressants and antipsychotics, anti-diabetics, statins, and other lipid-lowering drugs. Take antibiotics one month before the study begins Uncontrolled blood pressure ke probiotics and other dietary supplements within one months before the start of the study Metabolic E88.81 Prevention Placebo Intervention group: Will receive 300 g/day of synbiotic yogurt containing Lactobacillus Plantarum, Lactobacillus pentosus (2˟108 CFU), and Kluyveromyces marxianus and 3% of various natural plants (mountain celery, shallot, chicory, and mint) made by Yasuj Pasteurized Milk Company for 12 weeks. Control group: Will receive 300 g/day of regular yogurt made by Yasuj Pasteurized Milk Company for 12 weeks. IL-6. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: ELISA. TNF-α. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: ELISA. Hs-CRP. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Enzymatic. Gene expression of PPAR-γ. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Real time RT-PCR. Gene expression of LDL-R. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Real time RT-PCR. Gene expression of NF-κB. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Real time RT-PCR. Energy and macronutrients intake. Timepoint: Baseline, 6th week, and at the end of the intervention. Method of measurement: Three day dietary recall questionnaire. Physical activity. Timepoint: Baseline, 6th week, and at the end of the intervention. Method of measurement: International Physical Activity Questionnaire. Serum level of liver enzymes. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Enzymatic. Creatinine. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Enzymatic. Urea. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Enzymatic. Complete blood cells parameters. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Cell counter devices. Triglycerides. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Enzymatic method. Total cholesterol (TC). Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Enzymatic method. High-density lipoprotein cholesterol (HDL-C). Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Enzymatic method. Low-density lipoprotein cholesterol (LDL-C). Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Based on Friedwald's formula. Fasting blood sugar. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Enzymatic method. Blood pressure. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Mercury monometer. Body mass index. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Kg/m2. Waist circumference. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Tape. Tehran University of Medical Sciences Approved 2022-02-08 Ethics Committee of Tehran University of Medical Sciences Room 605, Sixth Floor, Central Building of Tehran University of Medical Sciences, Qods Street, Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)