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IRCT20120718010324N52 IRCT 2019-12-04 Tabriz University of Medical Sciences The Effect of Prebiotics on Menopausal Symptoms and Metabolic Indicators in Postmenopausal Women The Effect of Prebiotics on Menopausal Symptoms and Metabolic Indicators in Postmenopausal Women: A Randomized Clinical Trial 2019-11-30 anticipated 60 Complete https://irct.ir/trial/41105 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using block randomization method with block sizes of 4 and 6 and allocation ratio of 1:1 using Randomiser software, Blinding description: Participants, researcher, data analyst, and outcome assessors will be blinded due to the fact that the medications will be packaged in sealed envelopes and random allocation will be conducted by a person not involved in the study. 3 Menopausal symptoms. Intervention 1: The intervention group will receive one pocket of 20 gram perbiotic that will use in the glass of water daily for two months. Intervention 2: The control group will receive one pocket of 20 gram placebo (Maltodextrin) that will use in the glass of water daily for two months. No - There is not a plan to make this available Justification or reason for not sharing IPD is Participants data is confidential
public Sevda Gholizadeh shamasbi
Faculty of Nursing & Midwifery, South Shariati Street
Tabriz Iran (Islamic Republic of) 5138947977 +98 41 3479 6770 s.gholizadeh7007@gmail.com Tabriz University of Medical Sciences scientific Dr. Mojgan Mirghafourvand
Faculty of Nursing & Midwifery, South Shariati Street
Tabriz Iran (Islamic Republic of) 5138947977 +98 41 3479 6770 mirghafourvandm@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Willingness to participate in the study Having sufficient literacy to complete the questionnaire or the presence of a literate person in the family Natural menopause Being married Women who have been passed lower than 6 years from menopause. Having at least 40 years and a maximum of 60 Having hot flashes at least twice a week Not taking of probiotic, peribiotics, vitamins, minerals, and omega-3 during the study and three months before the intervention 40 years 60 years Female Use of tobacco, alcohol and herbal medicines Stressful factors such as the death of first-degree relatives in the last 6 months and the loss of a job Known psychiatric or systemic problems including cardiovascular, digestive tract, liver, blood and endocrine diseases, and ..... Taking of any effective medicines for hot flashes (clonidine, methyl dopa, gabapentin, selective serotonin reuptake inhibitors (SSRIs), norepinephrine inhibitors (SNRIs) and soy isoflavones The presence of factors causing vasomotor disorder, such as thyroid disease, according to the participant expression Use of food supplements Extreme physical activity (an activity that can not be easily talked about by an individual due to increased breathing and breathing). N95.1 Menopausal and female climacteric states Treatment - Drugs Placebo The intervention group will receive one pocket of 20 gram perbiotic that will use in the glass of water daily for two months. The control group will receive one pocket of 20 gram placebo (Maltodextrin) that will use in the glass of water daily for two months. Serum levels of metabolic indices (Insulin, fasting blood sugar and Lipid profile). Timepoint: Before intervention and two months after starting the intervention. Method of measurement: Blood tests. The total score of menopausal symptoms and its subscales. Timepoint: Before intervention and two months after starting the intervention. Method of measurement: Greene scale. Hot flashes number. Timepoint: Before intervention and two months after starting the intervention. Method of measurement: Checklist. Anthropometric indices (Waist circumference, hip circumference and body mass index). Timepoint: Before intervention and two months after starting the intervention. Method of measurement: Measuring with centimeter and scale. The frequency of side effects. Timepoint: During the study. Method of measurement: Checklist. Tabriz University of Medical Sciences Approved 2019-04-07 Ethics Committee of Tabriz University of Medical Sciences Reaserch department, third floor, central construction number 2, Tabriz university of medical sciences, Golgasht street, Azadi avenue Tabriz East Azarbaijan Iran (Islamic Republic of)