]>
IRCT20170221032698N2 IRCT 2021-09-20 Yazd University of Medical Sciences The effect of low calorie diets on anthropometric, glycemic, cardiovascular and hormonal factors in people with polycystic ovary syndrome Evaluation of the effect of Modified Alternate Day Fasting in comparison with energy restriction (Calorie Restriction) on anthropometric indices, glycemic markers, lipid parameters and hormone levels in people with polycystic ovary syndrome 2021-09-23 anticipated 44 Complete https://irct.ir/trial/58762 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: All participants were stratified for body mass index (BMI) and age, and were randomly assigned to ADF or CR group for 10 weeks. Randomization was performed using by random- generation software. N/A Polycystic ovary syndrome. Intervention 1: Intervention group: The normal diet of individuals is observed and followed for 2 weeks. Then, the ADF group consumed 25% of their energy on 3 days of the week (Saturday, Monday, Wednesday) for 8 weeks and then ate diet that providing 125% of their energy needs on each feed day (3 days a week). In Friday subjects consume ad libitum without limitation. These people received between 400 and 600 kcal of energy on fasting days. The feed and fast days began at midnight each day, and all fast day meals were consumed between 12.00 pm and 2.00 pm to ensure that each subject was undergoing the same duration of fasting. all food prepared in the home. Subjects were permitted to consume calorie- free foods (such as water, green tea, coffee without sugar ( < 400 mg caffeine per day), non- starchy vegetable (such as lettuce, cucumber, green leaf, tomato) and sugar free gums on the fast day and were encouraged to drink plenty of water. Intervention 2: Control group: The normal diet of individuals is observed and followed for 2 weeks. Then, in Calorie Restriction group, subjects consumed 75% energy needs in each day for 8 weeks and includes 3 main meals and 2 snacks. All subjects in two groups were required to prepare all of their meals at home. The baseline energy requirements for the subjects were assessed by Mifflin equation. Daily dietary carbohydrate, fat and protein accounted for 52, 30 and 18% of ingested energy, respectively. 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 Reyhaneh azizi
Diabetes Research and Treatment Center, Shahid Sadoughi Ave., Yazd, Iran
Yazd Iran (Islamic Republic of) 8917693571 +98 35 3728 0226 forough.nutritionist@gmail.com Yazd University of Medical Sciences scientific Reyhaneh Azizi
Diabetes Research and Treatment Center, Shahid Sadoughi Ave., Yazd, Iran
Yazd Iran (Islamic Republic of) 8917693571 +98 35 3728 0226 forough.nutritionist@gmail.com Yazd University of Medical Sciences Iran (Islamic Republic of) Women with polycystic ovary syndrome Age 25- 45 years 25 ≤ BMI ≤ 40 kg/m2 Body weight more than 5 kg has not changed during the last 3 months No fasting for 3 months prior to the beginning of the study Absence of diseases such as diabetes, cardiovascular, kidney, thyroid disorders, liver diseases, etc. Do not take medication, including drug that lower blood sugar, blood pressure and lipids. Also drugs that affect glycemic index and lipid parameters. No smoking and alcohol Intense physical inactivity Failure to follow specific diets People who, after explaining the work, are willing to cooperate and answer questions and perform experiments. 25 years 45 years Female Lack of cooperation of participants in different stages of project implementation People who lose the conditions to enter the study E28.2 Polycystic ovarian syndrome Lifestyle Lifestyle Intervention group: The normal diet of individuals is observed and followed for 2 weeks. Then, the ADF group consumed 25% of their energy on 3 days of the week (Saturday, Monday, Wednesday) for 8 weeks and then ate diet that providing 125% of their energy needs on each feed day (3 days a week). In Friday subjects consume ad libitum without limitation. These people received between 400 and 600 kcal of energy on fasting days. The feed and fast days began at midnight each day, and all fast day meals were consumed between 12.00 pm and 2.00 pm to ensure that each subject was undergoing the same duration of fasting. all food prepared in the home. Subjects were permitted to consume calorie- free foods (such as water, green tea, coffee without sugar ( < 400 mg caffeine per day), non- starchy vegetable (such as lettuce, cucumber, green leaf, tomato) and sugar free gums on the fast day and were encouraged to drink plenty of water. Control group: The normal diet of individuals is observed and followed for 2 weeks. Then, in Calorie Restriction group, subjects consumed 75% energy needs in each day for 8 weeks and includes 3 main meals and 2 snacks. All subjects in two groups were required to prepare all of their meals at home. The baseline energy requirements for the subjects were assessed by Mifflin equation. Daily dietary carbohydrate, fat and protein accounted for 52, 30 and 18% of ingested energy, respectively. Body Weighy. Timepoint: Two times, before and after dietary intervention. Method of measurement: Weight with minimal coverage and without shoes using a SECA weight scale with an accuracy of 100 grams. BMI. Timepoint: Two times, before and after dietary intervention. Method of measurement: Divide weight (kg) by height squared (m2). Waist circumference. Timepoint: Two times, before and after dietary intervention. Method of measurement: Between the lower margin of the last rib and the crown of the iliac bone at the level of the umbilicus and at the end of natural exhalation from the garment. Blood pressure. Timepoint: Two times, before and after dietary intervention. Method of measurement: Blood pressure is measured using a mercury sphygmomanometer after sitting for 10 minutes. Fasting blood sugar. Timepoint: Two times, before and after dietary intervention. Method of measurement: In the FBS test, the patient should fast for 10-12 hours. Its normal amount varies according to the kit and test method. In the enzymatic method, FBS in normal adults is 110-70 mg / dl. Total cholesterol. Timepoint: Two times, before and after dietary intervention. Method of measurement: The amount (TC) is measured by enzymatic methods. HDL. Timepoint: Two times, before and after dietary intervention. Method of measurement: The amount (HDL) is measured by enzymatic methods. Triglyceride. Timepoint: Two times, before and after dietary intervention. Method of measurement: The amount (TG) is measured by enzymatic methods. LDL. Timepoint: Two times, before and after dietary intervention. Method of measurement: Serum LDL will also be calculated using the Friedwald equation. Fat Mass. Timepoint: Two times, before and after dietary intervention. Method of measurement: Body composition analyzer. Fat Free Mass. Timepoint: Two times, before and after dietary intervention. Method of measurement: Body composition analyzer. Fasting insulin. Timepoint: Two times, before and after dietary intervention. Method of measurement: fasting insulin was assayed using ELISA kits. HOMA- IR. Timepoint: Two times, before and after dietary intervention. Method of measurement: HOMA-IR = fasting insulin (μU/ml) × fasting blood sugar (mg/dl) / 405. FSH. Timepoint: Two times, before and after dietary intervention. Method of measurement: FSH levels will be measured through the ELISA kit. LH. Timepoint: Two times, before and after dietary intervention. Method of measurement: LH levels will be measured through the ELISA kit. TSH. Timepoint: Two times, before and after dietary intervention. Method of measurement: TSH levels will be measured through the ELISA kit. Testosterone. Timepoint: Two times, before and after dietary intervention. Method of measurement: testosterone levels will be measured through the ELISA kit. Prolactin. Timepoint: Two times, before and after dietary intervention. Method of measurement: ICMA will be used to measure serum prolactin levels. Yazd University of Medical Sciences Approved 2021-06-30 Ethics committe of Shahid Sadoughi University of Medical Sciences Bahonar Sq., Shahid Sadoughi Ave., Shahid Sadoughi University of Medical Sciences, Yazd Yazd Yazd Iran (Islamic Republic of)