NCT06204965Not yet recruiting
Time-Restricted Eating as a Dietary Intervention for Polyendocrine Metabolic Ovarian Syndrome (PMOS): Protocol for a Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
Polyendocrine Metabolic Ovarian Syndrome (PMOS), previously known as PCOS, is a common endocrine disorder associated with metabolic, reproductive, and hormonal abnormalities. Growing evidence suggests that time-restricted eating (TRE) may improve body weight regulation, insulin sensitivity, hormonal balance, and menstrual function in women with PMOS. However, the mechanisms underlying these benefits remain unclear, particularly regarding the role of the gut microbiota and neurohormonal pathways. This randomized controlled trial will investigate whether combining an 8-hour TRE regimen with Healthy Eating Plate dietary recommendations provides greater benefits than dietary recommendations alone. Women aged 18-40 years with PMOS and overweight or obesity will participate in an 8-week intervention. The study will assess changes in gut microbiota composition, microbial metabolites, metabolic health, hormonal profile, neurohormonal markers, and body composition. The study is expected to provide novel insights into the interactions between meal timing, gut microbiota, neuroendocrine regulation, and clinical manifestations of PMOS, contributing to the development of more effective and sustainable dietary strategies for this condition.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 84 (estimated)
- First submitted
- 3 Jan 2024
- Start date
- 9 Jan 2027
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Joanna Bajerska
- NCT number
- NCT06204965
What you commit to
- Study type: Interventional
- Planned participants: 84
- From 9 Jan 2027 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- Eligible participants will be women aged 18-40 years with a BMI of 25-40 kg/m² and a physician-established diagnosis of PMOS established according to the 2023 International Evidence-based Guideline for the Assessment and Management of Polycystic Ovary Syndrome . The exclusion criteria, assessed at the screening visit by structured interview and review of medical documentation, will be:
- use within the previous 3 months of medications or supplements affecting carbohydrate or lipid metabolism, body weight, reproductive hormones including hormonal contraceptives, antiandrogens, glucocorticoids, weight-loss medications, insulin-sensitizing agents (e.g., metformin, inositols), probiotic or prebiotic supplements;
- antibiotic treatment within the previous 3 months
- smoking within the previous 3 months or alcohol consumption \>100 g/week;
- participation in competitive sports or structured athletic training;
- significant body weight fluctuations (\>5%) during the 3 months preceding study enrollment;
- current or past diagnosis of anorexia nervosa, bulimia nervosa, binge eating disorder, or other clinically significant eating disorders;
- pregnancy or breastfeeding;
- shift work or night work;
- diagnosed type 1 or type 2 diabetes.
Age in the registry: 18 years to 40 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Poznań University of Life Sciences Coordinator of this site? Confirm its status | Poznan | Poland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.