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IRCT20221122056575N1 IRCT 2022-12-24 Oroumia University of Medical Sciences Investigating the effect of two types of time restricted eating on glycemic, lipid indices, appetite, and sleep quality of women with polycystic ovary syndrome Investigating the effect of two types of time restricted eating on glycemic, lipid indices, appetite, and sleep quality of women with polycystic ovary syndrome 2022-11-10 anticipated 75 Complete https://irct.ir/trial/66984 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The block randomization method is used to equalize the sample size in the group step by step and in intervals called defined blocks, because in the simple randomization method, when the sample size is small, the sample is not balanced in the study arms. For this purpose, the online software for this type of randomization was used in the following link: https://www.sealedenvelope.com/simple-randomiser/v1/lists In this multimeter online software, including a total sample of 75 people, the number of groups (the names of the groups with capital letters A, B, C) and the number of blocks (the number of 3 blocks in the sizes of 3 and 6) were defined. Finally, by running the program, it gave us a random output list in which the sequence of people entering the study is shown. Because in the present study, the samples are gradually entered into the study, determining the sequence and the order of people's entry into the groups is carried out with this method, and the researcher performs the random allocation sequence of this list. In other words, each new person enters the study without research and is selected from his place in the target group, and according to this list, he places his samples in the target group. N/A Polycystic Ovary Syndrome. Intervention 1: Intervention group: People in the intervention groups will have a time-restricted eating of the type (14:10), in which people in the early time restricted eating (eTRE) group will be in a state of free consumption of food from 8:00 to 18:00. These people have been fasting for 14 hours and are only allowed to receive water and tea without sweets. Intervention 2: Intervention group: People in the intervention groups will have a time-restricted eating (14:10), in which the people in the mid-day time restricted eating (mTRE) group will eat freely from 11:00 to 21:00. Food is placed. These people have been fasting for 14 hours and are only allowed to receive water and tea without sweets. Intervention 3: Control group: People will continue their usual diet and there will be no time limit. 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 Sevana Daneghian
Orjhans Street, Resalat Blvd, Urmia , Iran
Urmia Iran (Islamic Republic of) 5714783734 +98 44 3223 4897 Sevana_d@yahoo.com Oroumia University of Medical Sciences scientific Sevana Daneghian
Orjhans Street, Resalat Blvd, Urmia , Iran
Urmia Iran (Islamic Republic of) 571478334 +98 44 3223 4897 Sevana_d@yahoo.com Oroumia University of Medical Sciences Iran (Islamic Republic of) Age 18 - 40 years 25 ≤ body mass index(BMI) ≤ 34.9 Women with PCOS diagnosed by the Rotterdam criteria 18 years 40 years Female pregnant or lactating night-shift workers, hypotension use of medication therapy that impacts carbohydrate or lipid metabolism (oral contraceptive pills, insulin-sensitizers, antiepileptics, statins, fish oil and ...) in the recent 3 months body weight fluctuations for more than 5% in the past 3 months Medicines that affect body weight Regular use of any drug or supplement that affects sleep Taking drugs that affect appetite at the time of entering the study Having a special diet Eating disorders or mental disorders night eating syndrome fasting for more than 14 h per day Congenital adrenal hyperplasia, androgen-secreting tumor, Cushing's syndrome, diabetes, thyroid dysfunction and hyperprolactinemia Cardiovascular, kidney, liver, lung and nervous diseases, digestive system surgery or food absorption disorders professional athlete perimenopausal Tobacco history Taking food supplements Sarcopenia E28.2 Polycystic ovarian syndrome Treatment - Other Treatment - Other Treatment - Other Intervention group: People in the intervention groups will have a time-restricted eating of the type (14:10), in which people in the early time restricted eating (eTRE) group will be in a state of free consumption of food from 8:00 to 18:00. These people have been fasting for 14 hours and are only allowed to receive water and tea without sweets. Intervention group: People in the intervention groups will have a time-restricted eating (14:10), in which the people in the mid-day time restricted eating (mTRE) group will eat freely from 11:00 to 21:00. Food is placed. These people have been fasting for 14 hours and are only allowed to receive water and tea without sweets. Control group: People will continue their usual diet and there will be no time limit. Fasting Blood Sugar. Timepoint: At the beginning and end of the study (after 6 weeks). Method of measurement: Biochemical analysis of blood sample. Fasting Insulin. Timepoint: At the beginning and end of the study (after 6 weeks). Method of measurement: Biochemical analysis of blood sample. Insulin resistance. Timepoint: At the beginning and end of the study (after 6 weeks). Method of measurement: Calculation of Homeostatic Model Assessment (HOMA). Total cholesterol. Timepoint: At the beginning and end of the study (after 6 weeks). Method of measurement: Biochemical analysis of blood sample. Triglyceride. Timepoint: At the beginning and end of the study (after 6 weeks). Method of measurement: Biochemical analysis of blood sample. High-density lipoprotein (HDL). Timepoint: At the beginning and end of the study (after 6 weeks). Method of measurement: Biochemical analysis of blood sample. Low-density lipoprotein (LDL). Timepoint: At the beginning and end of the study (after 6 weeks). Method of measurement: Biochemical analysis of blood sample. Appetite. Timepoint: beginning, middle and end of study (every two weeks). Method of measurement: Visual Analog Scale (VAS) questionnaire. Sleep quality. Timepoint: At the beginning and end of the study (after 6 weeks). Method of measurement: Petersburg’s sleep quality questionnaire. Body weight. Timepoint: At the beginning and end of the study (after 6 weeks). Method of measurement: scale. Waist circumference. Timepoint: At the beginning and end of the study (after 6 weeks). Method of measurement: Meter. Body mass index (BMI). Timepoint: At the beginning and end of the study (after 6 weeks). Method of measurement: Weight in kilograms divided by height squared in meters. Body composition. Timepoint: At the beginning and end of the study (after 6 weeks). Method of measurement: Bioelectric Impedance Analysis (BIA) device. Eating behavior. Timepoint: At the beginning and end of the study (after 6 weeks). Method of measurement: The Three-Factor Eating Questionnaire. Energy intake. Timepoint: beginning, middle and end of study (every two weeks). Method of measurement: 24-hour Dietary Recall. Carbohydrate intake. Timepoint: beginning, middle and end of study (every two weeks). Method of measurement: 24-hour Dietary Recall. Protein intake. Timepoint: beginning, middle and end of study (every two weeks). Method of measurement: 24-hour Dietary Recall. Fat intake. Timepoint: beginning, middle and end of study (every two weeks). Method of measurement: 24-hour Dietary Recall. Urmia University of Medical Sciences Approved 2022-11-16 Research ethics committee of Urmia University of Medical Sciences Boostan dormitory, Zaker St, Apadana Crossroad, Urmia City, West Azarbaijan Urmia West Azarbaijan Iran (Islamic Republic of)