Clinical trial · Interventional
The Impact of Time-restricted Eating on the Outcomes Associated With Polycystic Ovary Syndrome
The Impact of Time-restricted Eating on the Composition of the Intestinal Microbiota and Metabolic and Neurohormonal Parameters of Women With Polycystic Ovary Syndrome
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Time-restricted eating | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Time-restricted eating group (TRE group)
- description
- Participants assigned to the TRE group will be instructed to continue eating their usual diet during the experiment (without any qualitative or quantitative restrictions), but to eat it within a limited time frame - from 9:00 a.m. to 5:00 p.m., and then fast until the next day ( protocol 8/16).
- interventionNames
- Behavioral: Time-restricted eating
- type
- NO_INTERVENTION
- label
- Non-fasting group
- description
- Participants assigned to the control group will receive only dietary recommendations consistent with the healthy eating plate. Additionally, the recommended energy intake will be individually determined for each patient using the PPM (calculated using the Harris-Benedict formula) multiplied by the physical activity factor.
Primary outcomes (7)
- measure
- Change in body weight
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion criteria * Age 18-40 * suffering from Polycystic Ovary Syndrome, confirmed by appropriate medical documentation * BMI \>25 kg\^m2 Exclusion criteria * Taking medications regulating carbohydrate, lipid as well as medications affecting body weight in the last 3 months (will be assessed during a general medical interview conducted by Jakub Noskiewicz, MD, PhD) * Taking antibiotics in the last 3 months * Smoking in the last 3 months and alcohol consumption \>100 g per week * Competitive sports practice * Significant body weight fluctuations in the 3 months before the start of the study (\>5%) * Pregnant or breastfeeding women * BMI \<25 kg\^m2
References
Publications (5)
- BACKGROUNDLi C, Xing C, Zhang J, Zhao H, Shi W, He B. Eight-hour time-restricted feeding improves endocrine and metabolic profiles in women with anovulatory polycystic ovary syndrome. J Transl Med. 2021 Apr 13;19(1):148. doi: 10.1186/s12967-021-02817-2. PMID 33849562
- BACKGROUNDTorres PJ, Ho BS, Arroyo P, Sau L, Chen A, Kelley ST, Thackray VG. Exposure to a Healthy Gut Microbiome Protects Against Reproductive and Metabolic Dysregulation in a PCOS Mouse Model. Endocrinology. 2019 May 1;160(5):1193-1204. doi: 10.1210/en.2019-00050. PMID 30924862
- BACKGROUNDLiao B, Qiao J, Pang Y. Central Regulation of PCOS: Abnormal Neuronal-Reproductive-Metabolic Circuits in PCOS Pathophysiology. Front Endocrinol (Lausanne). 2021 May 28;12:667422. doi: 10.3389/fendo.2021.667422. eCollection 2021. PMID 34122341
- BACKGROUNDTremellen K, Pearce K. Dysbiosis of Gut Microbiota (DOGMA)--a novel theory for the development of Polycystic Ovarian Syndrome. Med Hypotheses. 2012 Jul;79(1):104-12. doi: 10.1016/j.mehy.2012.04.016. Epub 2012 Apr 27. PMID 22543078
- BACKGROUNDMinabe S, Iwata K, Tsuchida H, Tsukamura H, Ozawa H. Effect of diet-induced obesity on kisspeptin-neurokinin B-dynorphin A neurons in the arcuate nucleus and luteinizing hormone secretion in sex hormone-primed male and female rats. Peptides. 2021 Aug;142:170546. doi: 10.1016/j.peptides.2021.170546. Epub 2021 Mar 29. PMID 33794282