PCOS- Polycystic Ovary SyndromeNCT07298603
Nutrition Intervention for Women With Polycystic Ovary Syndrome
A study testing FertilOMed Diet and MedDiet in people with PCOS- Polycystic Ovary Syndrome and Nutrition Intervention, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- PCOS- Polycystic Ovary Syndrome, Nutrition Intervention, Nutrition Assessment
- What is being tested?
- FertilOMed Diet and MedDiet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Dec 2025to 30 Dec 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 join
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Ondokuz Mayıs University Kurupelit Campus
Samsun, Atakum
About this study
Official title: 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:
Read more
- 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.
Read the 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.
- Being tested
- FertilOMed Diet, MedDiet
- Keywords
- polycystic ovary syndrome, FertilOMed Diet, Mediterranean Diet, dietary intervention, reproductive health, Quality of life, oxidative stress
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FertilOMed DietOther
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.
MedDietOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Mediterranean Diet group | Active comparator | Participants follow Mediterranean Diet Receives: Other: MedDiet |
| FertilOMed Diet | Experimental | Participants follow Fertility-Optimized Mediterranean Diet Receives: Other: FertilOMed Diet |
| Control | No intervention | Participants receive standard dietary recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Participants follow the dietrary intervention and are assessed at baseline and at the end of the 12-week intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start3 Dec 2025
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCOS- Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Menşure Nur ÇELİK, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07298603
- Sponsor's protocol ID
- B.30.2ODM.0.20.08/569
- Status last verified
- Oct 2026
- First submitted
- 19 Nov 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No