NCT07298603Enrolling by invitation
Nutrition Intervention for Women With Polycystic Ovary Syndrome
Nutrition Intervention in PCOS: Clinical, Biochemical, and Symptomatic Effects of Different Dietary Models
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
The goal of this clinical trial is to evaluate whether different dietary models can improve clinical, metabolic, hormonal, anthropometric, and quality-of-life parameters in women with polycystic ovary syndrome (PCOS). The main questions it aims to answer are: * Do the Mediterranean Diet and the FertilOMed Diet (Fertility-Optimized Mediterranean Diet) lead to significant improvements in these parameters compared to the control group? * Does the FertilOMed Diet lead to greater improvements compared to the standard Mediterranean Diet? Study Description: This randomized controlled intervention study will be conducted between November 2025 and March 2026 at the Samsun Training and Research Hospital, Department of Obstetrics and Gynecology, Women's Health Outpatient Clinics. Necessary institutional permissions have been obtained for conducting the study at these sites. Participants: Women diagnosed with PCOS who meet the inclusion criteria and volunteer to participate will be included in the study. Interventions: Participants will be randomly assigned to one of the following groups: * Mediterranean Diet group * FertilOMed Diet group (Fertility-Optimized Mediterranean Diet) * Control group (standard dietary recommendations) Researchers will compare these groups to determine whether the dietary interventions improve clinical, biochemical, and symptomatic outcomes in women with PCOS.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- First submitted
- 19 Nov 2025
- Start date
- 3 Dec 2025
- Primary completion date
- 30 Nov 2027
- Lead sponsor
- Ondokuz Mayıs University
- NCT number
- NCT07298603
What you commit to
- Study type: Interventional
- Planned participants: 36
- From 3 Dec 2025 to the primary completion date, 30 Nov 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.
Prior treatment
- Having had bariatric surgery,
- Having used hormonal contraceptives or insulin sensitivity-enhancing medications within 3 months before the study start,
- Having used antioxidant supplements such as vitamin C within 1 month before the study start,
Other illness
- Having type 1 diabetes, type 2 diabetes, Cushing's syndrome, hypothyroidism, androgen tumors, active cancer, or a gastrointestinal system or malabsorption disease,
Age
- Being younger than 20 years old or older than 45 years old with PCOS diagnosis,
Other
- Having a BMI of ≤18.50 kg/m2 and ≥35.00 kg/m2,
- Being pregnant or breastfeeding,
- Using alcohol,
- Having used antibiotics and/or probiotics in the last month,
- Having a Mediterranean Diet Adherence Score (MEDAS) of ≥10,
- Those who did not give their consent after reading the informed consent form.
Who the study is looking for
- Being diagnosed with PCOS according to the Rotterdam Criteria, between the ages of 20 and 45,
- Having a Body Mass Index (BMI) of 18.50-35.00 kg/m2,
- Not having used antibiotics and/or probiotics in the last month,
- Signing a voluntary consent form.
Age in the registry: 20 years to 45 years · Sex: Female · Accepts 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 |
|---|---|---|---|
| Ondokuz Mayıs University Kurupelit Campus Coordinator of this site? Confirm its status | Samsun | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.