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Diet showdown: can a Fertility-Focused mediterranean diet beat standard advice for PCOS?

NCT ID NCT07298603

Symptom relief Sponsor: Ondokuz Mayıs University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two dietary approaches—a standard Mediterranean diet and a fertility-optimized version called FertilOMed—against usual care in 36 women with PCOS. Over 12 weeks, researchers will track changes in hormones, metabolism, weight, and quality of life to see if a targeted diet can ease PCOS symptoms.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Mediterranean Diet and FertilOMed Diet (a fertility-optimized Mediterranean diet)
What this could lead to
If it works, this could show that a tailored diet helps manage PCOS symptoms and improve hormone and metabolic health without medication.
What could go wrong
This is a small, early-stage study with only 36 participants, so results may not apply to everyone. Diet adherence can be hard to maintain, and the 12-week duration is short.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 36 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

May 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 to 45 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

polycystic ovary syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Nutrition assessment Nutrition intervention PCOS (polycystic ovary syndrome)

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Ondokuz Mayıs University Kurupelit Campus

    Samsun, Atakum, Turkey (Türkiye)

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