The effect of MIND diet with modified calories compared to low calorie diet on anxiety, depression, hormonal and metabolic status of obese or overweight women with polycystic ovary syndrome: A clinical trial.

Determining the effect of Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet with modified calories compared to low calorie diet on anxiety, depression, hormonal and metabolic status of obese or overweight women with polycystic ovary syndrome (PCOS)

A randomized controlled trial with 2 parallel groups (26 in each group). The random block was used for randomization.

52 patients with PCOS with the diagnosis of gynecologist, obstetric referred to Faculty of Nutrition Sciences will be selected. Then the subjects will be divided into two groups by permuted block randomization. The required energy will be calculated based on Mifflin-St Jeor formula, and in both groups the rate of 500-750 kcal will be deducted. In the intervention group, the diet will be determined based on the MIND dietary pattern and in the control group units of each food groups will be determined based on a regular diet. After 2 months of intervention, all groups will be compared. There is no possibility of blinding for dietary presentation.

Inclusion criteria: Aged 18 to 45 years old, body mass index equal to or higher than 25 kg/m2, and no recent weight loss during the previous 3 months Exclusion criteria: Having known metabolic, liver and neurological diseases, history of diagnosis of depression during the previous 1 year, and taking antidepressants and medications that affect appetite and body weight

The subjects divide into 2 groups, Group 1: receiving MIND diet with modified calorie. Group 2: receiving low calorie diet with usual dietary recommendations.

Anxiety and depression status; quality of life status; fasting blood sugar; LH; FSH; hirsutism; weight; waist circumference; hip circumference; body mass index; waist to hip ratio; blood pressure

The randomization method in this study is block randomization, the random sequence is generated by a statistical consultant. The registration of people is done by the project manager. Allocating people to groups is done by the statistics consultant. The team leader is different from the outcome assessor, and the team leader is not involved in the process of collecting information and evaluating the outcome, and this work will be done by trained evaluators. For random allocation of people,13 blocks with 4 permutations will be created. Then, based on the numbers in the random table, a number will be chosen randomly, and based on the last digit on the right, one of the groups will be used to determine the sequence of randomization. It should be noted that if the number on the right side is zero or 7 to 9 when choosing a random number, that number will not be considered and a random number will be selected again. This work will continue until all 52 people are assigned to two groups. It should be noted that this method will prevent the unbalance of the two groups as well as the identification of the randomization sequence, and the ratio of 1:1 will be observed in the two groups. It is registered and the cards are placed in the envelopes in order. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lids of the envelopes are glued and placed in a box respectively. At the time of starting the registration of participants, based on the order in which eligible participants entered the study, one of the envelopes will be opened and the assigned group of that participant will be revealed.

Data collected for the primary outcomes will be shared.

Accessibility to data is possible 8 months after publication.

The data will only be available for people working in academic institutions.

The data of the present study will only be accessible by other researchers, for conducting Meta analysis.

Dr Jalal Moludi, Faculty of Nutrition Sciences and Food Technology, Kermanshah University of Medical Sciences, +989399516766, j.moloudi@yahoo.com

Any one 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 these steps will not take more than 10 days.