Clinical trial · Interventional
Nutrition Intervention for Women With Polycystic Ovary Syndrome
Nutrition Intervention in PCOS: Clinical, Biochemical, and Symptomatic Effects of Different Dietary Models
- 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)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nutrition Assessment | — | UNRESOLVED | — |
| Nutrition Intervention | — | UNRESOLVED | — |
| PCOS- Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FertilOMed Diet | Other | — | UNRESOLVED |
| MedDiet | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Mediterranean Diet group
- description
- Participants follow Mediterranean Diet
- interventionNames
- Other: MedDiet
- type
- EXPERIMENTAL
- label
- FertilOMed Diet
- description
- Participants follow Fertility-Optimized Mediterranean Diet
- interventionNames
- Other: FertilOMed Diet
- type
- NO_INTERVENTION
- label
- Control
- description
- Participants receive standard dietary recommendations
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * Being younger than 20 years old or older than 45 years old with PCOS diagnosis, * 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 had bariatric surgery, * Having type 1 diabetes, type 2 diabetes, Cushing's syndrome, hypothyroidism, androgen tumors, active cancer, or a gastrointestinal system or malabsorption disease, * 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, * Having a Mediterranean Diet Adherence Score (MEDAS) of ≥10, * Those who did not give their consent after reading the informed consent form.
References
Publications (0)
Data not yet available