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IRCT20200912048693N3 IRCT 2022-12-23 Kermanshah University of Medical Sciences Comparison of the effect of portfolio low-carbohydrate diet and the ketogenic diet in women with polycystic ovary syndrome Comparison of the effect of portfolio low-carbohydrate diet and the ketogenic diet on anthropometric indices, hormonal and lipid profiles in overweight or obese women with polycystic ovary syndrome 2023-02-04 anticipated 46 Complete https://irct.ir/trial/67548 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The samples will be included in the study by random block method using 6 random blocks that will be created using the website https://www.sealedenvelope.com. The person who collects the information is unaware of the type of allocation of the samples to the study groups. The following items will be considered regarding the implementation of the random allocation process: a) One English letter is assigned to each of the groups: A to the low carbohydrate portfolio diet group, B to the ketogenic diet group. b) A sequence will be created for a sample size of 46. c) For the concealment process of random allocation, 46 non-transparent envelopes and cards (as much as the total sample size) will be prepared. Inside each envelope, 6 cards will be placed in the order of the sequence in each block. The number of blocks will be written on each envelope and the name of the desired group will be written on each card. N/A Polycystic ovarian syndrome. Intervention 1: Intervention group: ketogenic diet, in this group, the basic calorie amount of the participants is calculated through the formula of estimating the amount of energy consumed according to the amount of physical activity of them so that the total calories needed by the person are calculated. Then 500 kcal will be deducted from the diet offered to the person. The ketogenic diet will have a high-fat content (70%) and low carbohydrate (20%) which will cause the production of ketone bodies in the individual; Duration of intervention: 4 weeks. Intervention 2: Control group: Low-carbohydrate portfolio diet, in this group, the basic calorie amount of the participants is calculated through the formula of estimating the amount of energy consumed according to the amount of physical activity of them so that the total calories needed by the person are calculated. Then 500 kcal will be deducted from the diet offered to the person. The low-carbohydrate portfolio diet is a type of diet that consists of 40% of calories from carbohydrates, 20% from protein, and 40% from fat, emphasizing the consumption of four cholesterol-lowering substances, including vegetable protein, viscous fiber, nuts, and phytosterols. Duration of intervention: 4 weeks. Yes - There is a plan to make this available What will be shared: All data relating to the primary and secondary outcomes will be shared When: Access starts 6 months after the results are published To whom: Researchers in academic and scientific institutions, as well as people in the industry, are allowed to access the data Conditions: Anyone who request our data should provide a brief explanation of the purpose and method of their meta-analysis study. The applicant's request will be reviewed by the researchers and if all agree, the requested data will be sent to the applicant via email in the form of an Excel file. All of these steps will not take more than 10 days. Where to obtain: Amir Saber, Assistant Professor, Kermanshah University of Medical Sciences, Faculty of Nutrition Sciences and Food Industry, Address: Faculty of Nutrition Sciences and Food Industry, Next to Farabi hospital, Esar Square, Kermanshah Postal code: 6719851552 Phone: 0098 83 37102008 Email: amir.saber@kums.ac.ir How to obtain: After sending the request by the applicant and confirming the goals and method of the study by all project researchers, the data will be provided by email in less than 10 days. Comments:
public Amir Saber
Faculty of Nutrition Sciences and Food Industry, Next to Farabi hospital, Esar Square, Kermanshah
Kermanshah Iran (Islamic Republic of) 6719851552 +98 83 3710 2008 amir.saber@kums.ac.ir Kermanshah University of Medical Sciences scientific Amir Saber
Faculty of Nutrition Sciences and Food Industry, Next to Farabi hospital, Esar Square, Kermanshah
Kermanshah Iran (Islamic Republic of) 6719851552 +98 83 3710 2008 amir.saber@kums.ac.ir Kermanshah University of Medical Sciences Iran (Islamic Republic of) All women with PCOS that diagnosed by a gynecologist based on the Rotterdam criteria, which includes having at least 2 of the 3 listed symptoms 1) Oligomenorrhea or amenorrhea 2) Biochemical or clinical symptoms of increased androgen levels in the blood 3) Having polycystic ovaries in ultrasound. Having a body mass index of 25-39.9 kg/m2 Having a desire to lose weight 18 years 40 years Female Pregnancy Lactation Following special or low-calorie diets for at least the last three months Having diabetes Having adrenal gland disorders Having systematic or mental diseases Having thyroid diseases Taking drugs affecting carbohydrate or lipid metabolism Taking oral contraceptive pills Taking anti-epileptic pills Taking statins Fish oil consumption Use of fertility enhancing drugs or weight loss drugs Use of hormonal treatments or insulin sensitizing drugs in the last two months Having liver and kidney disease Having high blood pressure Having anemia Having severe respiratory diseases such as asthma and chronic inflammation of the bronchi Having cardiovascular diseases Having autoimmune diseases E28.2 Polycystic ovarian syndrome Rehabilitation Rehabilitation Intervention group: ketogenic diet, in this group, the basic calorie amount of the participants is calculated through the formula of estimating the amount of energy consumed according to the amount of physical activity of them so that the total calories needed by the person are calculated. Then 500 kcal will be deducted from the diet offered to the person. The ketogenic diet will have a high-fat content (70%) and low carbohydrate (20%) which will cause the production of ketone bodies in the individual; Duration of intervention: 4 weeks Control group: Low-carbohydrate portfolio diet, in this group, the basic calorie amount of the participants is calculated through the formula of estimating the amount of energy consumed according to the amount of physical activity of them so that the total calories needed by the person are calculated. Then 500 kcal will be deducted from the diet offered to the person. The low-carbohydrate portfolio diet is a type of diet that consists of 40% of calories from carbohydrates, 20% from protein, and 40% from fat, emphasizing the consumption of four cholesterol-lowering substances, including vegetable protein, viscous fiber, nuts, and phytosterols. Duration of intervention: 4 weeks Total cholesterol. Timepoint: At the beginning of the study (before the intervention) and at the end of the study. Method of measurement: Direct enzymatic method. LDL cholesterol. Timepoint: At the beginning of the study (before the intervention) and at the end of the study. Method of measurement: Direct enzymatic method. Fasting blood sugar. Timepoint: At the beginning of the study (before the intervention) and at the end of the study. Method of measurement: Glucose oxidase assay. Weight. Timepoint: At the beginning of the study (before the intervention) and at the end of the study. Method of measurement: Measure with a scale. Body mass index. Timepoint: At the beginning of the study (before the intervention) and at the end of the study. Method of measurement: Weight in kilograms divided by the square of height in meters. Insulin. Timepoint: At the beginning of the study (before the intervention) and at the end of the study. Method of measurement: Enzyme-Linked Immunosorbent Assay. Testosterone. Timepoint: At the beginning of the study (before the intervention) and at the end of the study. Method of measurement: Enzyme-Linked Immunosorbent Assay. Luteinizing hormone. Timepoint: At the beginning of the study (before the intervention) and at the end of the study. Method of measurement: Enzyme-Linked Immunosorbent Assay. Follicle stimulation hormone. Timepoint: At the beginning of the study (before the intervention) and at the end of the study. Method of measurement: Enzyme-Linked Immunosorbent Assay. Dehydroepiandrosterone. Timepoint: At the beginning of the study (before the intervention) and at the end of the study. Method of measurement: Enzyme-Linked Immunosorbent Assay. Vice Chancellor for Research, Kermanshah University of Medical Sciences Approved 2022-12-18 Ethics committee of Kermanshah University of Medical Sciences Faculty of Nutritional Sciences and Food Industry, next to Farabi hospital, Esar square, Kermanshah Kermanshah Kermanshah Iran (Islamic Republic of)