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IRCT20220426054667N1 IRCT 2022-05-18 Tehran University of Medical Sciences The effect of a new developed synbiotic yogurt consumption in adults with metabolic syndrome The effect of a new developed synbiotic yogurt consumption on metabolic syndrome components, oxidative stress status, and some other cardiovascular disease risk factors in adults with metabolic syndrome 2022-07-23 anticipated 44 Complete https://irct.ir/trial/63246 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients who meet the inclusion criteria will be randomly assigned to one of the two intervention groups. Randomization will be carried out using a block randomization procedure of size 2 and 4 stratified by sex (male or female) and BMI (25–29.9 or 30–35 kg/m2). Random allocation software will be used for generating a random sequence, 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 Somayyeh Asghari
No. 44, Shahid Hojjat Doost Alley, Naderi St, Keshavarz Boulevard
Tehran Iran (Islamic Republic of) 1416643931 0098 21 889900285 asghari.nut@gmail.com Tehran University of Medical Sciences scientific Somayyeh Asghari
No. 44, Shahid Hojjat Doost Alley, Naderi St, Keshavarz Boulevard
Tehran Iran (Islamic Republic of) 1416643931 0098 21 889900285 asghari.nut@gmail.com 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 Take probiotics and other dietary supplements within three months before the start of the study E88.81 Metabolic syndrome 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. Fasting blood sugar. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Enzymatic method. Insulin. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: ELISA. Triglycerides. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Enzymatic. ApoA1. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Immunoturbidometry. ApoB. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Immunoturbidometry. ApoA1/ApoB. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Blood concentration ratio ApoA1 / ApoB. Atherogenic index of plasma (AIP). Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: logTG/HDL formula. Oxidized LDL (Ox-LDL). Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: ELISA. Blood pressure. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Mercury monometer. Weight. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Digital scales. Malondialdehyde (MDA). Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Superoxide dismutase ( SOD). Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Glutathione Peroxidase (GPX). Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Total Oxidative status (TOS). Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Total antioxidant capacity (TAC). Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Insulin resistance index. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: HOMA-IR formula. HDL cholesterol. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Enzymatic. Height. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Stadiometer. Waist circumference. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: tape. Body mass index. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Kg/m2. 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. Tehran University of Medical Sciences Approved 2022-04-20 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)