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Comparing two Mediterranean-style diets for women with polycystic ovary syndrome

Compares two diets with usual advice in women with polycystic ovary syndrome.

Key facts

Who runs it
Ondokuz Mayıs University
Where
Samsun, TürkiyeSee the site
Trial code
Registry title
Nutrition Intervention for Women With Polycystic Ovary Syndrome
Status
Enrolling by invitation
People taking part
36 people, planned
Started
3 Dec 2025
Expected to end
30 Dec 2028
Type of study
Interventional, 3 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • FertilOMed Diet
  • MedDiet
Record updated
16 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for women with polycystic ovary syndrome (PCOS) to test whether different diets improve health, hormone and quality-of-life measures.

Age
20 to 45 years
Sex
Women only
Disease stage
PCOS diagnosed by the Rotterdam Criteria; BMI of 18.50-35.00 kg/m2
Earlier treatment
No antibiotics or probiotics in the last month

Main reasons for not taking part

  • Pregnant or breastfeeding
  • Uses alcohol
  • Had bariatric surgery
  • Type 1 or type 2 diabetes, Cushing's syndrome, hypothyroidism, androgen tumors, active cancer, or a gut or malabsorption disease
  • Hormonal contraceptives or insulin sensitivity-enhancing medications in the 3 months before the study

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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,
  • Having type 1 diabetes, type 2 diabetes, Cushing's syndrome, hypothyroidism, androgen tumors, active cancer, or a gastrointestinal system or malabsorption disease,
  • 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 a Mediterranean Diet Adherence Score (MEDAS) of ≥10,
  • Those who did not give their consent after reading the informed consent form

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 20 and 45 years old?

Where in Türkiye

  • Ondokuz Mayıs University Kurupelit CampusSamsun, TürkiyeNo longer taking part

About the trial

What the trial wants to find out

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).

Read full original descriptionShow less

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.

The 3 groups in the trial

  • Mediterranean Diet groupExisting treatment, for comparison

    Participants follow Mediterranean Diet

    Treatment: MedDiet

  • FertilOMed DietTreatment being tested

    Participants follow Fertility-Optimized Mediterranean Diet

  • ControlNo study treatment, for comparison

    Participants receive standard dietary recommendations

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Nutrition Intervention in PCOS: Clinical, Biochemical, and Symptomatic Effects of Different Dietary Models
Plain-language title
Comparing two Mediterranean-style diets for women with polycystic ovary syndromeGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07298603, who can take part
Record updated
16 October 2026