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IRCT20231210060323N1 IRCT 2023-12-14 Shiraz University of Medical Sciences Effect of Yoghurt Fortified with Probiotics and Vitamins D and E in Treatment of Polycystic Ovary Syndrome The Effect of Yoghurt Fortified with Probiotics and Vitamins D and E on Anthropometric and Biochemical Indices, Blood Pressure, Sleep Quality, and Mental Health in Patients with Polycystic Ovary Syndrome: A Randomized, Double-Blind, Controlled Clinical Trial 2024-01-21 anticipated 90 Complete https://irct.ir/trial/74232 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be randomly assigned using random blocks (ratio 1:1) for two groups (a control group and an intervention group). In this way, the double blocks will be created by someone outside the study. Then, a block is randomly selected to determine the assigned groups for the first two participants. In order to blind the researchers of this project, the assigned group will be placed in sealed envelopes by a person other than the researcher and a person outside the study, and in this way the allocation will be concealed. During the study, as each participant enters the study, according to the order, an envelope is opened and the assigned group is determined, Blinding description: In order to blind the interventions, fortified yogurts (including two types of intervention yogurt and low-fat conventional yogurt) will be provided to people in deposable containers with the same color, smell, taste and appearance, which will be named with the letters A and B. The process of filling the yogurt containers and naming them will be done by someone outside the study, and the members of the research team and the participants of the different groups will be unaware of the type of intervention and the type of yogurt they received, so that the principles for blinding will be accomplished. 3 Polycystic ovary syndrome. Intervention 1: Intervention group: Intaking120 grams per day of low-fat yogurt containing vitamin D (with a dose of 1000 IU or 25 micrograms) and vitamin E (with a dose of 50 IU or 34 mg) and two probiotic strains of lactobacillus (Lactobacillus acidophilus LA5) and bifidobacterium (Bifidobacterium animalis BB12) at least 10^6 cfu/g for 8 weeks. Intervention 2: Control group: Intaking120 grams per day of conventional low-fat yogurt for 8 weeks as a placebo. 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 No decision has been made.
public Moein Askarpour
Faculty of Nutrition and Food Sciences, Razi Boulevard
Shiraz Iran (Islamic Republic of) 7134814336 +98 71 3725 1001 askarpourmoein1994@gmail.com Shiraz University of Medical Sciences scientific Najmeh Hejazi
Faculty of Nutrition and Food Sciences, Razi Boulevard
Shiraz Iran (Islamic Republic of) 7134814336 +98 71 3725 1001 najmehhejazi@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Willingness to cooperate in the study and provide written consent Being in the reproductive age range of 18-45 years Diagnosis of polycystic ovary syndrome based on the Rotterdam criteria No intake of alcohol or drugs Not pregnant or breastfeeding No menopause No participate in other research studies 18 years 45 years Female Using drugs affecting blood pressure, blood lipids, ovarian function, insulin sensitivity (including metformin, incretin, and Thiazolidinediones) and oral contraceptives (including progesterone and estrogen) since 3 months before entering the study. Taking any nutritional supplements for 3 months before entering the study Taking drugs affecting vitamin D metabolism having diabetes, thyroid disease or any systemic disease (such as kidney, liver, digestive system, cardiovascular system) Having disorders that lead to an increase in androgens in the blood (such as Cushing's syndrome, hyperprolactinemia) E28.2 Polycystic ovarian syndrome Treatment - Other Treatment - Other Intervention group: Intaking120 grams per day of low-fat yogurt containing vitamin D (with a dose of 1000 IU or 25 micrograms) and vitamin E (with a dose of 50 IU or 34 mg) and two probiotic strains of lactobacillus (Lactobacillus acidophilus LA5) and bifidobacterium (Bifidobacterium animalis BB12) at least 10^6 cfu/g for 8 weeks Control group: Intaking120 grams per day of conventional low-fat yogurt for 8 weeks as a placebo Homeostasis model assessment of insulin resistance. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention). Method of measurement: Formula. Weight. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention). Method of measurement: Scale. Body Mass Index. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention). Method of measurement: Formula. Waist Circumference. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention). Method of measurement: Stadiometer. Hip Circumference. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention). Method of measurement: Stadiometer. Waist to Hip Ratio. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention). Method of measurement: Formula. Systolic Blood Pressure. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention). Method of measurement: Electronic Sphygmomanometer. Diastolic Blood Pressure. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention). Method of measurement: Electronic Sphygmomanometer. Fasting Blood Sugar. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention). Method of measurement: Pars Azmoon Kit. Fasting Insulin. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention). Method of measurement: ELISA Kit. The Quantitative Insulin Sensitivity Check Index. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention). Method of measurement: Formula. Total Cholesterol. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention). Method of measurement: Pars Azmoon Kit. Triglyceride. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention). Method of measurement: Pars Azmoon Kit. Low-Density Lipoprotein Cholesterol. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention). Method of measurement: Pars Azmoon Kit. High-Density Lipoprotein Cholesterol. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention). Method of measurement: Pars Azmoon Kit. Total Testosterone. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention). Method of measurement: ELISA Kit. Sex Hormone Binding Globulin. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention). Method of measurement: ELISA Kit. Dehydroepiandrosterone Sulfate. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention). Method of measurement: ELISA Kit. Luteinizing Hormone. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention). Method of measurement: Pars Azmoon Kit. Follicle-Stimulating Hormone. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention). Method of measurement: Pars Azmoon Kit. Free Androgen Index. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention). Method of measurement: Formula. High-Sensitivity C-Reactive Protein. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention). Method of measurement: ELISA Kit. Malondialdehyde. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention). Method of measurement: Spectrophotometry. Total Antioxidant Capacity. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention). Method of measurement: Spectrophotometry. Mental Health. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention). Method of measurement: The Depression, Anxiety and Stress Scale - 21 Items Questioner. Quality of Sleep. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention). Method of measurement: Pittsburgh Sleep Quality Index. Body Fat Percentage. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention). Method of measurement: Body Composition Analyzer. Skeletal Muscle Mass. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention). Method of measurement: Body Composition Analyzer. Shiraz University of Medical Sciences Approved 2023-10-22 Ethics committee in research of the faculties of health, nutrition and food sciences-Shiraz Universi Faculty of Health, Nutrition and Food Sciences, Razi Boulevard, Shiraz Shiraz Fars Iran (Islamic Republic of)