NCT06204965

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

Status unknown NA Last updated 17 January 2024

What this trial tests

NA trial testing Time-restricted eating in Polycystic Ovary Syndrome in 52 participants. Status unknown.

Timeline

12 December 2023

Primary endpoint
31 December 2024

31 December 2025

Quick facts

Lead sponsor	Joanna Bajerska
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	52
Start date	12 December 2023
Primary completion	31 December 2024
Estimated completion	31 December 2025
Sites	1 location across Poland

Drugs / interventions tested

• Time-restricted eating

Conditions studied

• Polycystic Ovary Syndrome — all drugs for Polycystic Ovary Syndrome →

Sponsor

Joanna Bajerska

Who can join

Adults 18 to 40, female only, with Polycystic Ovary Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Tuned by time: the role of circadian rhythms in metabolic energy sensing and chronotherapy.
   Thanuskodi Rajakumar A, Kodiveri Muthukaliannan G. · · 2025 · PMID 41339276 · DOI 10.1080/07853890.2025.2596548