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Nutrition Intervention for Women With Polycystic Ovary Syndrome

Sponsored by Ondokuz Mayıs University

About this trial

Last updated 6 months ago

Study ID

B.30.2ODM.0.20.08/569

Status

Enrolling by invitation

Type

Interventional

Phase

N/A

Placebo

No

Accepting

20 to 45 Years
Female

Trial Timing

Ended 12 days ago

What is this trial about?

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.

What are the participation requirements?

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.