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IRCT20200915048731N1 IRCT 2020-09-29 Yazd University of Medical Sciences Effect of diet therapy with and without Curcumin in treatment of Polycystic Ovary Syndrome Investigation of the Effects of DASH and Standard Diets With and Without Curcumin Supplementation on Gene Expression of Interleukin-1 Alpha , 5 Alpha – Reductase, Serum Concentration of Testosterone and Glycemic Indices in Infertile Women With Polycystic Ovary Syndrome Candidate for In Vitro Fertilization (IVF) 2022-04-03 anticipated 96 Complete https://irct.ir/trial/50970 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Treatment, Randomization description: The participants will be assigned to four groups according to the method of Stratified Permuted Block Randomization based on BMI (BMI:18.5-25 and BMI ≥25), in equal block sizes of 4; Therefore, participants will have an equal chance for being in each group. A random allocation list will be created by Package ‘blockrand’ in R software, 4.0.2 version. The intervention groups will be randomly allocated into 4 groups: Group 1: 500 mg Curcumin twice daily and DASH diet, Group 2: 500 mg Curcumin twice daily and standard diet, Group 3: 500 mg Placebo twice daily and DASH diet, Group 4: 500 mg Placebo twice daily and standard diet, Blinding description: Supplements and placebos capsules will be provided in the same appearance (in terms of color and shape) and packed in similar bottles. The bottles will be labeled with different marks (A and B), by someone not related to the study. Each bottle contains 64 capsules (for one month use and two days of grace period). Participants and researchers will not be aware of bottles content. As well as intervention groups will be assigned to receive two healthy dietary patterns (DASH or standard diet). These diets will be designed in the form of an individual diet containing 18 % protein, 52 % carbohydrates, and 30 % total fat. Overall, DASH and standard patterns will be designed using similar foods and recipes, but in different amounts, to achieve the specific characteristics of each diet.The amount of sodium prescribed for each diet will be the same. Two Midwifery experts will check the baseline measurements, a COVID-19 screening, inclusion and exclusion criteria. They will give consecutive numbers to eligible participant and refer them to a nutritionist who is not involved in this study. Participants will receive their specific diet through face-to-face individual counseling. 12- Week menu plans (7-day cycle menu with 21 meals) at eleven energy levels (1200, 1300, 1400, 1500, 1600, 1700, 1800, 1900, 2000, 2100 and 2200 kcal) for both dietary patterns will be constructed and analyzed. Both diets will be planned by the study dietitian and reviewed by the chief Investigator. These will be considered as the basis for participants' individual diets. Then the specific diet of each person will be calculated. Nutritionist IV software will be used for calculations. In our opinion, this study is double-blind, because all the researchers and final analysts will remain conceal from the allocation and will not be able to distinguish between groups. Participants will only aware of the type of diet but will not know the content of placebo or curcumin supplement. N/A Polycystic ovary syndrome. Intervention 1: "Intervention group 1:" Curcumin capsules and DASH diet; in this intervention group, 24 patients will receive 500 milligrams of Curcumin capsule twice daily and DASH diet for 12 weeks, each person's diet will designed individually. The Dietary Approaches to Stop Hypertension (DASH) diet is a diet that emphasizes vegetables, fruits and low-fat dairy products; and moderate amounts of whole grains, poultry, fish, and nuts; while it contains only small amounts of red meat, sweets, and sugar-containing beverages. The DASH diet will be designed to contain 52 % carbohydrates, 18 % protein, and 30 % total fat; if a person is overweight or obese, the patient's calculated energy will be reduced by 300 and 500 kcal, respectively.12- Week menu plans (7-day cycle menu with 21 meals) at eleven energy levels (1200, 1300, 1400, 1500, 1600, 1700, 1800, 1900, 2000, 2100 and 2200 kcal) will be constructed and analyzed. These will be considered as the basis for participants' individual diets. Nutritionist IV software (Diet analysis, Module version 3.5.2) will be used for calculations. Participants will receive their specific diet through face-to-face individual counseling, initial assessment and intervention for 45 to 60-minutes with a Registered Dietitian (follow- up visits will take 15 to 30 minutes per month). They will also receive a bottle of capsules (on 1st day, 30th day and 60th day of visit), each bottle containing 64 capsules (providing supplement for 1 month and a grace period of 2 days). Administration instructions on taking the pills and what to do if there is a missed dose will be set for patients, including taking two capsules a day (one after breakfast and one after evening meal with water) and taking the missed capsule the same day. Daily supplementation will be checked by contacting the participants using phone interviews and messaging tools (WhatsApp) twice a day. Intervention 2: "Intervention group 2:" Curcumin capsules and standard diet; in this intervention group, 24 patients will receive 500 milligrams of Curcumin capsule twice daily and standard diet for 12 weeks, each person's diet will designed individually.The standard diet will be designed to contain 52 % carbohydrates, 18 % protein, and 30 % total fat; if a person is overweight or obese, the patient's calculated energy will be reduced by 300 and 500 kcal, respectively.12- Week menu plans (7-day cycle menu with 21 meals) at eleven energy levels (1200, 1300, 1400, 1500, 1600, 1700, 1800, 1900, 2000, 2100 and 2200 kcal) will be constructed and analyzed. These will be considered as the basis for participants' individual diets. Nutritionist IV software (Diet analysis, Module version 3.5.2) will be used for calculations. Participants will receive their specific diet through face-to-face individual counseling, initial assessment and intervention for 45 to 60-minutes with a Registered Dietitian (follow- up visits will take 15 to 30 minutes per month). They will also receive a bottle of capsules (on 1st day, 30th day and 60th day of visit), each bottle containing 64 capsules (providing supplement for 1 month and a grace period of 2 days). Administration instructions on taking the pills and what to do if there is a missed dose will be set for patients, including taking two capsules a day (one after breakfast and one after evening meal with water) and taking the missed capsule the same day. Daily supplementation will be checked by contacting the participants using phone interviews and messaging tools (WhatsApp) twice a day. Intervention 3: "Intervention group 3:" Placebos capsules and DASH diet; in this intervention group, 24 patients will receive 500 milligrams of placebo capsule twice daily and DASH diet for 12 weeks, each person's diet will designed individually. Placebos capsules will be provided in the similar appearance with curcumin capsules (in terms of color and shape) and packed in same bottles. The DASH diet will be designed to contain 52 % carbohydrates, 18 % protein, and 30 % total fat; if a person is overweight or obese, the patient's calculated energy will be reduced by 300 and 500 kcal, respectively. 12- Week menu plans (7-day cycle menu with 21 meals) at eleven energy levels (1200, 1300, 1400, 1500, 1600, 1700, 1800, 1900, 2000, 2100 and 2200 kcal) will be constructed and analyzed. These will be considered as the basis for participants' individual diets. Nutritionist IV software (Diet analysis, Module version 3.5.2) will be used for calculations. Participants will receive their specific diet through face-to-face individual counseling, initial assessment and intervention for 45 to 60-minutes with a Registered Dietitian (follow- up visits will take 15 to 30 minutes per month). They will also receive a bottle of capsules (on 1st day, 30th day and 60th day of visit), each bottle containing 64 capsules (providing supplement for 1 month and a grace period of 2 days). Administration instructions on taking the pills and what to do if there is a missed dose will be set for patients, including taking two capsules a day (one after breakfast and one after evening meal with water) and taking the missed capsule the same day. Daily supplementation will be checked by contacting the participants using phone interviews and messaging tools (WhatsApp) twice a day. Intervention 4: "Control group:" Placebos capsules and standard diet; in this group, 24 patients will receive 500 milligrams of placebo capsule twice daily and standard diet for 12 weeks, each person's diet will designed individually. The standard diet will be designed to contain 52 % carbohydrates, 18 % protein, and 30 % total fat; if a person is overweight or obese, the patient's calculated energy will be reduced by 300 and 500 kcal, respectively. 12- Week menu plans (7-day cycle menu with 21 meals) at eleven energy levels (1200, 1300, 1400, 1500, 1600, 1700, 1800, 1900, 2000, 2100 and 2200 kcal) will be constructed and analyzed. These will be considered as the basis for participants' individual diets. Nutritionist IV software (Diet analysis, Module version 3.5.2) will be used for calculations. Participants will receive their specific diet through face-to-face individual counseling, initial assessment and intervention for 45 to 60-minutes with a Registered Dietitian (follow- up visits will take 15 to 30 minutes per month). They will also receive a bottle of capsules (on 1st day, 30th day and 60th day of visit), each bottle containing 64 capsules (providing supplement for 1 month and a grace period of 2 days). Administration instructions on taking the pills and what to do if there is a missed dose will be set for patients, including taking two capsules a day (one after breakfast and one after evening meal with water) and taking the missed capsule the same day. Daily supplementation will be checked by contacting the participants using phone interviews and messaging tools (WhatsApp) twice a day. 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 "There is no further information"
public Tayebeh Zohrabi
Safaeiye Ave., Alam Square., Public Health faculty., Shahid Sadoughi University of Medical Science., Yazd
Yazd Iran (Islamic Republic of) 8915173160 +98 35 3820 9100 zohrabitayebeh@yahoo.com Yazd University of Medical Sciences scientific Hassan Mozaffari Khosravi
Safaeiye Ave., Alam Square., Public Health faculty., Shahid Sadoughi University of Medical Science., Yazd
Yazd Iran (Islamic Republic of) 8915173160 +98 35 3820 9100 mozaffari.kh@gmail.com Yazd University of Medical Sciences Iran (Islamic Republic of) Infertile women with PCOS diagnosed according to Rotterdam criteria. Aged 18–40 years Candidate for IVF without previous history of IVF Having a BMI range of 18.5-25 and BMI ≥25 kg/m² 18 years 40 years Female Metabolic and endocrine abnormalities including thyroid dysfunction, Cushing's syndrome, diabetes or impaired glucose tolerance, hyperprolactinemia, congenital adrenal hyperplasia, liver disease, cardiovascular disease, kidney disease, hypertension, neurological diseases, any history of mental illness, having cancer, autoimmune and inflammatory disorders (rheumatoid arthritis). Smoking by the patient or her spouse Alcohol drinking Taking contraceptives or any other drugs that may affect reproductive physiology (during the three months before the study) Taking anti-diabetic, anti-obesity, estrogenic and androgenic drugs Taking supplements such as vitamin C, vitamin E and omega-3 because of their anti-inflammatory and antioxidant effects, three months before or during the intervention. E28.2 Polycystic ovarian syndrome Treatment - Drugs Treatment - Drugs Treatment - Other Placebo "Intervention group 1:" Curcumin capsules and DASH diet; in this intervention group, 24 patients will receive 500 milligrams of Curcumin capsule twice daily and DASH diet for 12 weeks, each person's diet will designed individually. The Dietary Approaches to Stop Hypertension (DASH) diet is a diet that emphasizes vegetables, fruits and low-fat dairy products; and moderate amounts of whole grains, poultry, fish, and nuts; while it contains only small amounts of red meat, sweets, and sugar-containing beverages. The DASH diet will be designed to contain 52 % carbohydrates, 18 % protein, and 30 % total fat; if a person is overweight or obese, the patient's calculated energy will be reduced by 300 and 500 kcal, respectively.12- Week menu plans (7-day cycle menu with 21 meals) at eleven energy levels (1200, 1300, 1400, 1500, 1600, 1700, 1800, 1900, 2000, 2100 and 2200 kcal) will be constructed and analyzed. These will be considered as the basis for participants' individual diets. Nutritionist IV software (Diet analysis, Module version 3.5.2) will be used for calculations. Participants will receive their specific diet through face-to-face individual counseling, initial assessment and intervention for 45 to 60-minutes with a Registered Dietitian (follow- up visits will take 15 to 30 minutes per month). They will also receive a bottle of capsules (on 1st day, 30th day and 60th day of visit), each bottle containing 64 capsules (providing supplement for 1 month and a grace period of 2 days). Administration instructions on taking the pills and what to do if there is a missed dose will be set for patients, including taking two capsules a day (one after breakfast and one after evening meal with water) and taking the missed capsule the same day. Daily supplementation will be checked by contacting the participants using phone interviews and messaging tools (WhatsApp) twice a day. "Intervention group 2:" Curcumin capsules and standard diet; in this intervention group, 24 patients will receive 500 milligrams of Curcumin capsule twice daily and standard diet for 12 weeks, each person's diet will designed individually.The standard diet will be designed to contain 52 % carbohydrates, 18 % protein, and 30 % total fat; if a person is overweight or obese, the patient's calculated energy will be reduced by 300 and 500 kcal, respectively.12- Week menu plans (7-day cycle menu with 21 meals) at eleven energy levels (1200, 1300, 1400, 1500, 1600, 1700, 1800, 1900, 2000, 2100 and 2200 kcal) will be constructed and analyzed. These will be considered as the basis for participants' individual diets. Nutritionist IV software (Diet analysis, Module version 3.5.2) will be used for calculations. Participants will receive their specific diet through face-to-face individual counseling, initial assessment and intervention for 45 to 60-minutes with a Registered Dietitian (follow- up visits will take 15 to 30 minutes per month). They will also receive a bottle of capsules (on 1st day, 30th day and 60th day of visit), each bottle containing 64 capsules (providing supplement for 1 month and a grace period of 2 days). Administration instructions on taking the pills and what to do if there is a missed dose will be set for patients, including taking two capsules a day (one after breakfast and one after evening meal with water) and taking the missed capsule the same day. Daily supplementation will be checked by contacting the participants using phone interviews and messaging tools (WhatsApp) twice a day. "Intervention group 3:" Placebos capsules and DASH diet; in this intervention group, 24 patients will receive 500 milligrams of placebo capsule twice daily and DASH diet for 12 weeks, each person's diet will designed individually. Placebos capsules will be provided in the similar appearance with curcumin capsules (in terms of color and shape) and packed in same bottles. The DASH diet will be designed to contain 52 % carbohydrates, 18 % protein, and 30 % total fat; if a person is overweight or obese, the patient's calculated energy will be reduced by 300 and 500 kcal, respectively. 12- Week menu plans (7-day cycle menu with 21 meals) at eleven energy levels (1200, 1300, 1400, 1500, 1600, 1700, 1800, 1900, 2000, 2100 and 2200 kcal) will be constructed and analyzed. These will be considered as the basis for participants' individual diets. Nutritionist IV software (Diet analysis, Module version 3.5.2) will be used for calculations. Participants will receive their specific diet through face-to-face individual counseling, initial assessment and intervention for 45 to 60-minutes with a Registered Dietitian (follow- up visits will take 15 to 30 minutes per month). They will also receive a bottle of capsules (on 1st day, 30th day and 60th day of visit), each bottle containing 64 capsules (providing supplement for 1 month and a grace period of 2 days). Administration instructions on taking the pills and what to do if there is a missed dose will be set for patients, including taking two capsules a day (one after breakfast and one after evening meal with water) and taking the missed capsule the same day. Daily supplementation will be checked by contacting the participants using phone interviews and messaging tools (WhatsApp) twice a day. "Control group:" Placebos capsules and standard diet; in this group, 24 patients will receive 500 milligrams of placebo capsule twice daily and standard diet for 12 weeks, each person's diet will designed individually. The standard diet will be designed to contain 52 % carbohydrates, 18 % protein, and 30 % total fat; if a person is overweight or obese, the patient's calculated energy will be reduced by 300 and 500 kcal, respectively. 12- Week menu plans (7-day cycle menu with 21 meals) at eleven energy levels (1200, 1300, 1400, 1500, 1600, 1700, 1800, 1900, 2000, 2100 and 2200 kcal) will be constructed and analyzed. These will be considered as the basis for participants' individual diets. Nutritionist IV software (Diet analysis, Module version 3.5.2) will be used for calculations. Participants will receive their specific diet through face-to-face individual counseling, initial assessment and intervention for 45 to 60-minutes with a Registered Dietitian (follow- up visits will take 15 to 30 minutes per month). They will also receive a bottle of capsules (on 1st day, 30th day and 60th day of visit), each bottle containing 64 capsules (providing supplement for 1 month and a grace period of 2 days). Administration instructions on taking the pills and what to do if there is a missed dose will be set for patients, including taking two capsules a day (one after breakfast and one after evening meal with water) and taking the missed capsule the same day. Daily supplementation will be checked by contacting the participants using phone interviews and messaging tools (WhatsApp) twice a day. Interleukin 1 Alpha gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Real time Polymerase Chain Reaction (PCR). 5 Alpha reductase gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Real time Polymerase Chain Reaction (PCR). Testosterone. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa method. 5α-dihydrotestosterone. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa method. Insulin. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa method. Homeostasis model assessment of insulin resistance (HOMA-IR). Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Calculation using HOMA-IR formula. Fasting blood sugar. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic method. Anthropometric indices. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Anthropometric indices will be measure, including weight using calibrated Seca scale with an accuracy of 0.1 kg and a minimum of clothes ; height, waist and hip circumference using a tape measure with an accuracy of 0.5 cm; as well as Body Mass Index and waist-hip ratio will be calculated. Body composition. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Measurement of body composition, including muscle mass (MM), fat mass (FM), and fat free mass (FFM)], using Bioelectric Impedance Analyzer ( BIA). Energy and nutrient intake. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Using 3 Days food record (2 days per week and one day off) and analyzing with Nutritionist 4 software. Physical activity. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: physical activity questionnaire. Iran National Science Foundation Yazd University of Medical Sciences Iran National Science Foundation Approved 2020-09-09 Ethics committee of Shahid Sadoughi University of Medical Science Safaeiye Ave., Alam Square., Shahid Sadoughi University of Medical Science., Yazd. Yazd Yazd Iran (Islamic Republic of)