The Effect of Yoghurt Fortified with Probiotics and Vitamins D and E on Anthropometric and Biochemical Indices, Blood Pressure, Sleep Quality, and Mental Health in Patients with Polycystic Ovary Syndrome: A Randomized, Double-Blind, Controlled Clinical Trial

The effect of yogurt fortified with probiotics, vitamin D and vitamin E on anthropometric indices, biochemical indices, blood pressure, sleep quality and mental health in patients with polycystic ovary syndrome.

This clinical trial is randomized, double-blind, placebo-controlled and parallel in phase 3, on 90 eligible people. Ninety people are allocated between two groups by block randomization method (45 people in each group).

Patients referred to Shiraz Mother and Child Hospital after knowing about the study, if they agree and obtain written and informed consent, are randomly assigned to 2 study groups (using the block randomization method). The participants receive the yogurts corresponding to their group, which are named in line with the names of the groups with letters A and B for the blinding of the participant and the researcher, and consume them daily before meals for 8 weeks. Evaluation of anthropometric and biochemical indicators, and completion of mental health and sleep quality questionnaires are done before and after the study.

Exclusion criteria: Women with polycystic ovary syndrome between the ages of 18 and 45 who are not breastfeeding or pregnant. Inclusion criteria: have no history of chronic diseases and have not taken antibiotics and nutritional supplements for 3 months before entering the study.

1- Intervention group: 8 weeks of intaking120 grams per day of low-fat yogurt containing vitamin D (with a dose of 1000 IU or 25 micrograms), vitamin E (with a dose of 50 IU or 34 mg) and probiotics (Bifidobacterium animalis BB12 and Lactobacillus Acidophilus LA-5 in a dose of at least 10^6 CFU/gr) 2- Placebo group: 8 weeks of intaking120 grams per day of plain low-fat yogurt as a placebo

HOMA-IR

Participants will be randomly assigned using random blocks (ratio 1:1) for two groups (a control group and an intervention group). In this way, the double blocks will be created by someone outside the study. Then, a block is randomly selected to determine the assigned groups for the first two participants. In order to blind the researchers of this project, the assigned group will be placed in sealed envelopes by a person other than the researcher and a person outside the study, and in this way the allocation will be concealed. During the study, as each participant enters the study, according to the order, an envelope is opened and the assigned group is determined.

In order to blind the interventions, fortified yogurts (including two types of intervention yogurt and low-fat conventional yogurt) will be provided to people in deposable containers with the same color, smell, taste and appearance, which will be named with the letters A and B. The process of filling the yogurt containers and naming them will be done by someone outside the study, and the members of the research team and the participants of the different groups will be unaware of the type of intervention and the type of yogurt they received, so that the principles for blinding will be accomplished.