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

Determining the effect of low carbohydrate portfolio diet and ketogenic diet on anthropometric indices, hormonal and lipid profiles of overweight or obese women with polycystic ovary syndrome

Two arms parallel-group randomized trial with a control group, phase 2 on 46 patients. The random block was used for randomization.

46 women with polycystic ovary syndrome referred to Motazadi medical center with the diagnosis of gynecologists, obstetrics and endocrinologists, if there are at least two factors based on the Rotterdam criteria, are diagnosed and selected from the following cases. People will be randomly divided into two groups: ketogenic diet (intervention) and low carbohydrate portfolio diet (control). There is no possibility of blinding for dietary presentation.

Inclusion criteria: Female, Aged 18-40 years, Having Polycystic ovary syndrome according to Rotterdam criteria. Body mass index 25-39.9 kg/m2, Desire to lose weight; Exclusion criteria: Pregnancy, Lactation, Following special or low-calorie diets for at least the last three months, Having diabetes, Having adrenal gland disorders, Having thyroid diseases, Taking effective drugs on carbohydrate or lipid metabolism, Use of oral contraceptive pills, Use of antiepileptic pills, Use of fish oil, Use of drugs to enhance fertility or weight loss, Having hypertension, Having cardiovascular diseases, Having anemia

Patients in the intervention group will receive a ketogenic diet, which will have a high-fat content (70%) and low carbohydrate content (20%) Patients in the control group will receive a low-carbohydrate portfolio diet, which consists of 40% of calories from carbohydrates, 20% from protein, and 40% from fat. The duration of the intervention will be 4 weeks

Total cholesterol, LDL cholesterol, Fasting blood sugar

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.

All data relating to the primary and secondary outcomes will be shared

Access starts 6 months after the results are published

Researchers in academic and scientific institutions, as well as people in the industry, are allowed to access the data

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.

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

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.