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IRCT20120913010826N33 IRCT 2023-06-12 Research Assistant, Yazd University of Medical Sciences Effect of legume-based DASH diet in patients with polycystic ovary syndrome The effects of legume-based DASH diet on anthropometric factors, glucose & lipid profiles and testosterone level in women with polycystic ovary syndrome (PCOS): A randomized clinical trial 2023-06-20 anticipated 54 Complete https://irct.ir/trial/70572 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: The term "legumes" includes legumes, soybeans, peas, beans, etc, Randomization description: The stratified randomization method is used for random allocation. Therefore, we first classify BMI into three groups: standard, overweight, and obese, and then use a simple random assignment method in each group. First, eligible people are classified into BMI groups, and then in each BMI group, the first eligible person is number 1 and the next person is number 2, and so on until the 27th person. Random Allocation software version 1 is used to prepare the random allocation list. 3 polycystic ovary syndrome. Intervention 1: Intervention group: Legume-based DASH diet. DASH diet (Dietary Approaches to Stop High Blood Pressure) that contains 50-55% carbohydrates, 15-20% protein and 25-30% fat. The DASH diet is high in fruits, vegetables, whole grains, and low-fat dairy, and low in saturated fat, cholesterol, and refined grains. In the legume-based DASH diet, we replace up to 1 to 3 units of meat and grains with more legumes and soybeans. The calories needed by each patient are estimated based on the basal metabolic rate (using the Harris-Benedict equation) and the levels of physical activity and energy resulting from food metabolism. For people who are overweight or obese, a caloric restriction of 500 to 700 kcal less than the calculated energy requirement for each person is considered. 500 kcal for those whose BMI is in the range of 25-31 kg/m2 and 700 kcal for those with a BMI greater than 31 kg/m2 will be deducted from the total energy needed by each person, and weight loss is intended for these people. The replacement list is provided to the patient while educating the patient to make it easier to choose foods and comply with the principle of diversity between the components of each food group. Intervention 2: Control group: A standard diet that contains 50-55% carbohydrates, 15-20% protein and 25-30% fat. The calories needed by each patient are estimated based on the basal metabolic rate (using the Harris-Benedict equation) and the levels of physical activity and energy resulting from food metabolism. For people who are overweight or obese, a caloric restriction of 500 to 700 kcal less than the energy requirement calculated for each person is considered. 500 kcal for people whose BMI is in the range of 25-31 kg/m2 and for people whose BMI is more than 31 kg/m2, 700 kcal is deducted from the total energy requirement of each person, and weight loss for These people are considered. The replacement list is provided to the patient while educating the patient to make it easier to choose foods and comply with the principle of variety between the components of each food group. 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 It is not yet known if there will be a plan to make this available
public Dr Azadeh Najarzadeh
Shohaday-e-Gomnam Blvd., Alem Sq., Yazd, Iran
Yazd Iran (Islamic Republic of) 8915173160 +98 35 3149 2232 azadehnajarzadeh@gmail.com Yazd University of Medical Sciences scientific Dr Azadeh Najarzadeh
Shohaday-e-Gomnam Blvd., Alem Sq., Yazd, Iran
Yazd Iran (Islamic Republic of) 8915173160 +98 35 3149 2232 azadehnajarzadeh@gmail.com Yazd University of Medical Sciences Iran (Islamic Republic of) Women of reproductive age and before menopause (20-50 years) Women with PCOS according to the Rotterdam criteria Oligomenorrhea or amenorrhea Clinical or laboratory hyperandrogenism 20 years 50 years Female Pregnancy, miscarriage or breastfeeding in the last 6 months Oligomenorrhea caused by secondary causes, including endocrine disorders (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome, hyperprolactinemia, adrenal disorders) Previous history or current getting with any cancer History of type 2 diabetes Intrauterine Insemination (IUI) or In Vitro Fertilization) IVF( Special diets or low-calorie diets in the past three months, including vegetarian diets E28.2 Polycystic ovarian syndrome Lifestyle Lifestyle Intervention group: Legume-based DASH diet. DASH diet (Dietary Approaches to Stop High Blood Pressure) that contains 50-55% carbohydrates, 15-20% protein and 25-30% fat. The DASH diet is high in fruits, vegetables, whole grains, and low-fat dairy, and low in saturated fat, cholesterol, and refined grains. In the legume-based DASH diet, we replace up to 1 to 3 units of meat and grains with more legumes and soybeans. The calories needed by each patient are estimated based on the basal metabolic rate (using the Harris-Benedict equation) and the levels of physical activity and energy resulting from food metabolism. For people who are overweight or obese, a caloric restriction of 500 to 700 kcal less than the calculated energy requirement for each person is considered. 500 kcal for those whose BMI is in the range of 25-31 kg/m2 and 700 kcal for those with a BMI greater than 31 kg/m2 will be deducted from the total energy needed by each person, and weight loss is intended for these people. The replacement list is provided to the patient while educating the patient to make it easier to choose foods and comply with the principle of diversity between the components of each food group. Control group: A standard diet that contains 50-55% carbohydrates, 15-20% protein and 25-30% fat. The calories needed by each patient are estimated based on the basal metabolic rate (using the Harris-Benedict equation) and the levels of physical activity and energy resulting from food metabolism. For people who are overweight or obese, a caloric restriction of 500 to 700 kcal less than the energy requirement calculated for each person is considered. 500 kcal for people whose BMI is in the range of 25-31 kg/m2 and for people whose BMI is more than 31 kg/m2, 700 kcal is deducted from the total energy requirement of each person, and weight loss for These people are considered. The replacement list is provided to the patient while educating the patient to make it easier to choose foods and comply with the principle of variety between the components of each food group. HOMA-IR index. Timepoint: Before intervention and 16 weeks after intervention. Method of measurement: HOMA-IR = (Glu ×Insulin)/405. Low density lipoprotein cholesterol (LDL). Timepoint: Before intervention and 16 weeks after intervention. Method of measurement: Special kit. High density lipoprotein cholesterol (HDL). Timepoint: Before intervention and 16 weeks after intervention. Method of measurement: Special kit. Triglyceride. Timepoint: Before intervention and 16 weeks after intervention. Method of measurement: Special kit. Total cholesterol. Timepoint: Before intervention and 16 weeks after intervention. Method of measurement: Special kit. FBS. Timepoint: Before intervention and 16 weeks after intervention. Method of measurement: Special kit. Serum insulin. Timepoint: Before intervention and 16 weeks after intervention. Method of measurement: Special kit. Free testosterone. Timepoint: Before intervention and 16 weeks after intervention. Method of measurement: Special kit. Weight, fat mass, fat free mass, RMR, body mass index and visceral fat. Timepoint: Before intervention and 16 weeks after the intervention. Method of measurement: Omron digital Scale. Waist,Hip circumference. Timepoint: Before intervention and 16 weeks after the intervention. Method of measurement: Meter. Total energy intake, total nutrients intake. Timepoint: Before intervention and 16 weeks after the intervention. Method of measurement: 24 hour recall. The length of the menstrual cycle. Timepoint: Before intervention and 16 weeks after the intervention. Method of measurement: questionnaire. Research Assistant, Yazd University of Medical Sciences Approved 2023-05-28 Ethics committee of School of Public Health, Shahid Sadoughi University of Medical Sciences, Shohaday-e-Gomnam Blvd., Alem Sq., Yazd, Iran Yazd Yazd Iran (Islamic Republic of)