The Impact of Time-restricted Eating on the Outcomes Associated With Polycystic Ovary Syndrome - Trial NCT06204965

Timeline & Enrollment

Primary Outcome

Change in body weight,Change in circumferences,Change in body composition,Change in composition of the intestinal microbiota,Change in selected hormonal parameters,Change in lipid profile,Change in glucose metabolism

Summary

Polycystic Ovary Syndrome (PCOS) is a disorder that affects approximately 10-15% of women of
 reproductive age. Increased activity of the hypothalamic-pituitary-ovarian (HPO) axis is
 considered to be one of the main factors associated with the pathogenesis of PCOS. The
 regulation of the activity of this axis is influenced by the following factors: insulin
 resistance and the activity of kisspeptins in the hypothalamus. It is suggested that
 intestinal dysbiosis may also play a key role in the pathogenesis of PCOS. It was noticed
 that the presence of bacteria producing gamma-aminobutyric acid in the intestine is
 positively correlated with the concentration of luteinizing hormone (LH) in the serum, which
 indicates the relationship between the functioning of the gut-brain axis and PCOS. A
 dysbiotic factor is an incorrect diet and inappropriate timing of its consumption, which may
 also lead to inhibition of kisspeptin expression in the hypothalamus and cause menstrual
 disorders.
 
 Due to the fact that most obese women with PCOS eat significantly more meals in the second
 part of the day, and these meals are characterized by a significant supply of fat and simple
 sugars, intestinal dysbiosis seems to be an important cause of the observed disorders, while
 the use of chrononutrition, consisting in synchronizing meal times with endogenous 24-hour
 circadian rhythms may partially restore eubiosis in the intestine and improve the
 reproductive, metabolic and neurohormonal health of women with PCOS. Time-restricted feeding
 (TRF), which involves eating food usually within 8 hours followed by 16 hours of fasting,
 seems to be a regime that allows restoring eubiosis in the intestinal microbiota and
 improving the quality of life of women with PCOS. So far, only one study has been conducted
 among women with PCOS who used TRF for 5 weeks and a number of positive changes were
 demonstrated (hormonal or metabolic). However, this study did not include an assessment of
 the microbial and neurohormonal parameters, which seems to be a key issue.
 
 Taking the above into account, it was hypothesized that TRF may be an appropriate therapeutic
 tool for women with PCOS, which will positively affect metabolic and hormonal parameters by
 changing the composition of the intestinal microbiota. Therefore, the main aim of the
 experiment is to investigate the impact of TRF on the composition of the intestinal
 microbiota, its metabolites, and metabolic and neurohormonal parameters in women with PCOS.

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