Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT07298603

Nutrition Intervention for Women With Polycystic Ovary Syndrome

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

About this study

This study will include volunteer female individuals who have applied to the Gynecology and Obstetrics outpatient clinic of the Gynecology and Obstetrics Department of Samsun Training and Research Hospital, diagnosed with PCOS by a physician, and selected according to inclusion and exclusion criteria. Women who meet the criteria will be informed about the study's objectives and methodology, and those who agree to participate will be asked to sign a consent form. Individuals will be assigned to control and intervention groups, matched by age and BMI. Care will be taken to ensure that the groups are matched by age and body mass index (BMI). At the beginning of the study, a questionnaire containing sociodemographic information, general health information, dietary habits, physical activity status, sleep habits, morningness-eveningness scale, PCOS-50 Quality of Life scale, Beck depression scale, SF-36 scale, and food consumption record will be administered to the individuals via face-to-face interviews by the researcher. Initial anthropometric measurements of the female volunteers will be taken by the researcher using appropriate techniques. Additionally, biochemical findings will be obtained from hospital records at the beginning and end of the study. Volunteers, matched by age and BMI, were included in the control and intervention groups and will be followed for 12 weeks. Individuals in the control group will receive only medical treatment throughout the study period. They will be free to make food choices without energy restrictions (ad libitum). No dietary intervention will be implemented. Individuals in the intervention groups will receive ad libitum nutrition education and brochures about the diet's content, in addition to their medical treatment. Individuals in both intervention groups will not be restricted in their daily dietary energy intake.

During the 12-week follow-up period, individuals will be closely monitored through mobile applications and routine follow-up visits.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Changes in Hormonal Profile

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

    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.

  2. Changes in Metabolic Profile

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

    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.

  3. Changes in Oxidative Stress

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

    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.

Secondary outcomes

  1. Changes in Body Mass Index (BMI)

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

    Body mass index (BMI) will be calculated using weight (kg) and height (m²). Although weight and height will be measured, only BMI (kg/m²) will be reported as the outcome variable. Changes in BMI from baseline to the end of the 12-week dietary intervention will be evaluated to assess the impact of the intervention on anthropometric status.

  2. Change in Waist Circumference

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

    Anthropometric parameter used to assess central adiposity.

  3. Change in Hip Circumference

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

    Anthropometric parameter used to evaluate lower-body fat distribution.

  4. Change in Waist-to-Hip Ratio

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

    Derived anthropometric index reflecting fat distribution.

  5. Change in Neck Circumference

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

    Anthropometric indicator associated with upper-body fat distribution.

  6. Change in Body Fat Percentage

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

    Body fat percentage will be measured using the TANITA BC-545N bioelectrical impedance device under standardized conditions (8-hour fasting, light clothing, removal of metal/electronic items). Changes from baseline to Week 12 will be assessed.

  7. Change in Lean Mass

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

    Lean mass will be measured using the TANITA BC-545N device under standardized measurement conditions. Changes from baseline to Week 12 will be evaluated.

  8. Change in Muscle Mass

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

    Muscle mass will be assessed via TANITA BC-545N using standardized fasting and measurement procedures. Change from baseline to Week 12 will be recorded.

  9. Change in Total Body Water

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

    Total body water will be assessed via TANITA BC-545N. Device output will be reported as percentage (%) or liters (L), depending on the measurement format. Changes from baseline to Week 12 will be evaluated.

  10. Change in Depression Symptoms (Beck Depression Inventory)

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

    Depressive symptoms will be evaluated using the Beck Depression Inventory (BDI).

  11. Change in PCOS-Specific Quality of Life (PCOSQ-50)

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

    The PCOSQ-50 questionnaire assesses PCOS-specific quality of life across multiple domains.

  12. Change in Health-Related Quality of Life (SF-36)

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

    The SF-36 evaluates general health-related quality of life.

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Official study title

Nutrition Intervention in PCOS: Clinical, Biochemical, and Symptomatic Effects of Different Dietary Models

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 23, 2025
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.