Nutrition Intervention for Women With Polycystic Ovary Syndrome

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Nutrition Assessment; Nutrition Intervention; PCOS- Polycystic Ovary Syndrome
• Intervention / Treatment: Other: MedDiet; Other: FertilOMed Diet

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Atakum
    • Samsun, Atakum, Turkey (Türkiye)
      • Ondokuz Mayıs University Kurupelit Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Mediterranean Diet group; Participants follow Mediterranean Diet	Other: MedDiet; 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.
Experimental: FertilOMed Diet; Participants follow Fertility-Optimized Mediterranean Diet	Other: FertilOMed Diet; 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.
No Intervention: Control; Participants receive standard dietary recommendations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Body Mass Index (BMI)	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.	Participants follow the dietrary intervention and are assessed at baseline and at the end of the 12-week intervention.
Change in Waist Circumference	Anthropometric parameter used to assess central adiposity.	Participants follow the dietrary intervention and are assessed at baseline and at the end of the 12-week intervention.
Change in Hip Circumference	Anthropometric parameter used to evaluate lower-body fat distribution.	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	Derived anthropometric index reflecting fat distribution.	Participants follow the dietrary intervention and are assessed at baseline and at the end of the 12-week intervention.
Change in Neck Circumference	Anthropometric indicator associated with upper-body fat distribution.	Participants follow the dietrary intervention and are assessed at baseline and at the end of the 12-week intervention.
Change in Body Fat Percentage	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.	Participants follow the dietrary intervention and are assessed at baseline and at the end of the 12-week intervention.
Change in Lean Mass	Lean mass will be measured using the TANITA BC-545N device under standardized measurement conditions. Changes from baseline to Week 12 will be evaluated.	Participants follow the dietrary intervention and are assessed at baseline and at the end of the 12-week intervention.
Change in Muscle Mass	Muscle mass will be assessed via TANITA BC-545N using standardized fasting and measurement procedures. Change from baseline to Week 12 will be recorded.	Participants follow the dietrary intervention and are assessed at baseline and at the end of the 12-week intervention.
Change in Total Body Water	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.	Participants follow the dietrary intervention and are assessed at baseline and at the end of the 12-week intervention.
Change in Depression Symptoms (Beck Depression Inventory)	Depressive symptoms will be evaluated using the Beck Depression Inventory (BDI).	Participants follow the dietrary intervention and are assessed at baseline and at the end of the 12-week intervention.
Change in PCOS-Specific Quality of Life (PCOSQ-50)	The PCOSQ-50 questionnaire assesses PCOS-specific quality of life across multiple domains.	Participants follow the dietrary intervention and are assessed at baseline and at the end of the 12-week intervention.
Change in Health-Related Quality of Life (SF-36)	The SF-36 evaluates general health-related quality of life.	Participants follow the dietrary intervention and are assessed at baseline and at the end of the 12-week intervention.

Collaborators and Investigators

• Sponsor: Ondokuz Mayıs University

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2025
• Primary Completion (Estimated): March 30, 2026
• Study Completion (Estimated): May 30, 2026

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: December 21, 2025
• First Posted (Actual): December 23, 2025

Study Record Updates

• Last Update Posted (Actual): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 21, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: polycystic ovary syndrome; Quality of life; reproductive health; oxidative stress; Mediterranean Diet; dietary intervention; FertilOMed Diet
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Ovarian Cysts; Cysts; Polycystic Ovary Syndrome
• Other Study ID Numbers: B.30.2ODM.0.20.08/569

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No