Effects of a Novel Fortified Dairy Product on the Psychological Status and Sleep Quality of Patients with Polycystic Ovary Syndrome: A Double-Blind Randomized Controlled Trial

Polycystic ovary syndrome (PCOS) is a neuroendocrine disorder that commonly causes anovulation and infertility worldwide. Aside from infertility, patients with PCOS suffer from sleep disturbances and mental health issues. Recent studies have shown that functional foods may have a beneficial impact on psychological disorders and sleep quality. Therefore, the present study aimed to investigate the effects of daily intake of a fortified yogurt on the psychological and sleep profiles of women with PCOS. In this 8-week randomized double-blind controlled trial, after a 2-week run-in period, participants in the intervention group (n=45) received yogurt fortified with 10⁶ colony-forming units/g of probiotics (<i>Bifidobacterium animalis</i> Bb-12 and <i>Lactobacillus acidophilus</i> La-5) along with 50 IU of vitamin E and 1,000 IU of vitamin D, and those in the placebo group (n=45) received low-fat yogurt. The psychological status and sleep quality of patients were measured using the Depression, Anxiety, and Stress Scale-21 Items and Pittsburgh Sleep Quality Index before and after the study, respectively. The registration number of this study was IRCT20231210060323N1. The results showed that the intervention group exhibited a significant improvement in depression status compared with the placebo group (<i>P</i>=0.01). However, no statistically beneficial impact was observed on sleep quality in patients with PCOS (<i>P</i>=0.44). This trial indicated that consuming yogurt with probiotics, vitamin E, and vitamin D may alleviate depression in patients with PCOS and that nutritional interventions could be advantageous, particularly for individuals who prefer not to take antidepressant medications. However, further research is needed to confirm the results.