Nutrition Intervention in PCOS: Clinical, Biochemical, and Symptomatic Effects of Different Dietary Models
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Changes in Hormonal Profile
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Changes in Hormonal Profile
时间窗: 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.
Changes in Metabolic Profile
时间窗: 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.
Changes in Oxidative Stress
时间窗: 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.
次要结局
- 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.)
- 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 Neck Circumference(Participants follow the dietrary intervention and are assessed at baseline and at the end of the 12-week intervention.)
- Change in Body Fat Percentage(Participants follow the dietrary intervention and are assessed at baseline and at the end of the 12-week intervention.)
- Change in Lean Mass(Participants follow the dietrary intervention and are assessed at baseline and at the end of the 12-week intervention.)
- Change in Muscle Mass(Participants follow the dietrary intervention and are assessed at baseline and at the end of the 12-week intervention.)
- Change in Total Body Water(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)(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)(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)(Participants follow the dietrary intervention and are assessed at baseline and at the end of the 12-week intervention.)
研究者
Menşure Nur ÇELİK
Principal Investigator
Ondokuz Mayıs University