Nutrition Intervention for Women With Polycystic Ovary Syndrome

NCT07298603 | Enrolling By Invitation

• 1 other identifier: B.30.2ODM.0.20.08/569
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

PCOS- Polycystic Ovary Syndrome; Nutrition Intervention; Nutrition Assessment

Keywords

polycystic ovary syndrome; FertilOMed Diet; Mediterranean Diet; dietary intervention; reproductive health; Quality of life; oxidative stress

Outcome Measures

Primary Outcomes (3)

• Changes in Hormonal Profile

  The primary outcome measure of this study is to evaluate holistic changes in the reproductive-metabolic profile of individuals with PCOS following the dietary intervention. This composite outcome includes coordinated changes in hormonal balance (e.g., FSH, LH, Estradiol, Progesterone, 17-Hydroxyprogesterone, DHEAS, T4, TSH, Prolactin, SHBG, AMH, Total Testosterone, and FAI). All parameters will be measured at baseline and after the 12-week dietary intervention, and changes will be analyzed to determine the overall impact of the applied dietary model. These parameters will be obtained by scanning the participants' routine results from their file information.

  Participants follow the dietrary intervention and are assessed at baseline and at the end of the 12-week intervention.

• Changes in Metabolic Profile

  The primary outcome measure of this study is to evaluate holistic changes in the reproductive-metabolic profile of individuals with PCOS following the dietary intervention. This composite outcome includes coordinated changes in metabolic profile (e.g., , AST, ALT, Hemogram, D Vitamini, B12 Vitamini, SHBG, HbA1c, AMH, Total Testosteron, Glukoz, İnsülin, HOMA IR, HDL, LDL, Trigliserit, Total Kolesterol). All parameters will be measured at baseline and after the 12-week dietary intervention, and changes will be analyzed to determine the overall impact of the applied dietary model. These parameters will be obtained by scanning the participants' routine results from their file information.

  Participants follow the dietrary intervention and are assessed at baseline and at the end of the 12-week intervention.

• Changes in Oxidative Stress

  The primary outcome measure of this study is to evaluate holistic changes in the reproductive-metabolic profile of individuals with PCOS following the dietary intervention. This composite outcome includes coordinated changes in hormonal balance (e.g.,TAC, Vit C, SOD, Catalase, Glutathione Peroxidase (GPx) and Malondialdehyde (MDA)). All parameters will be measured at baseline and after the 12-week dietary intervention, and changes will be analyzed to determine the overall impact of the applied dietary model. These parameters will be determined by performing validated commercial ELISA kits in accordance with the manufacturer's instructions and evaluating with a microplate reader.

  Participants follow the dietrary intervention and are assessed at baseline and at the end of the 12-week intervention.

Secondary Outcomes (12)

• Changes in Body Mass Index (BMI)

  Participants follow the dietrary intervention and are assessed at baseline and at the end of the 12-week intervention.

• Change in Waist Circumference

  Participants follow the dietrary intervention and are assessed at baseline and at the end of the 12-week intervention.

• Change in Hip Circumference

  Participants follow the dietrary intervention and are assessed at baseline and at the end of the 12-week intervention.

• Change in Waist-to-Hip Ratio

  Participants follow the dietrary intervention and are assessed at baseline and at the end of the 12-week intervention.

• Change in Neck Circumference

  Participants follow the dietrary intervention and are assessed at baseline and at the end of the 12-week intervention.

Study Arms (3)

Mediterranean Diet group

ACTIVE COMPARATOR

Participants follow Mediterranean Diet

Other: MedDiet

FertilOMed Diet

EXPERIMENTAL

Participants follow Fertility-Optimized Mediterranean Diet

Other: FertilOMed Diet

Control

NO INTERVENTION

Participants receive standard dietary recommendations

Interventions

FertilOMed Diet OTHER

FertilOMed Diet (Experimental): Participants will follow the FertilOMed Diet, which is based on the standard Mediterranean Diet guidelines, with required consumption of specific foods and adherence to recommended food group portions. Dietary adherence will be monitored through food diaries and follow-up consultations.

FertilOMed Diet

MedDiet OTHER

Mediterranean Diet (Active Comparator): Participants will follow a standard Mediterranean Diet for the duration of the study. Dietary adherence will be monitored through food diaries and follow-up consultations.

Mediterranean Diet group

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Ondokuz Mayıs University Kurupelit Campus

Samsun, Atakum, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 23, 2025
• Study Start: December 3, 2025
• Primary Completion: March 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)