Polycystic Ovary SyndromePCOSNCT07385716
Evaluation of the Effect of Time-Restricted Feeding and Mediterranean Diet Model in Women With Polycystic Ovary Syndrome
A study testing Mediterranean diet and intermittent fasting in people with Polycystic Ovary Syndrome, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
Currently, there is still insufficient data to support the long-term efficacy, safety, and health benefits of time-restricted feeding models in women diagnosed with Polycystic ovary syndrome (PCOS), and further studies are needed to test and validate the effects of long-term dietary management in PCOS. Read more about this study
- Who is it for?
- Ages 20 to 49 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Mediterranean diet and intermittent fasting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2026to 20 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Being between 20-49 years of age
- Having been diagnosed with PCOS by a specialist according to Rotterdam criteria
- Having a BMI between 25-35 kg/m2
- Not having any conditions that impair reality testing and cognitive functions, preventing interviews or completing scales
- Being literature
- Having signed the informed consent form by agreeing to participate in the study.
Who cannot join
- Combination of other endocrine etiological disorders according to Rotterdam criteria (congenital adrenal hyperplasia, Cushing syndrome, androgen-secreting tumors, hyperprolactinemia, thyroid, adrenal and other endocrine disorders)
- Combination of cardiovascular and cerebrovascular diseases, hematological disorders, hepatic and renal failure and other serious diseases
- Liver and kidney disease
- Use of insulin or oral antidiabetic drugs,
- Being pregnant and lactating
- Low compliance and non-compliance with treatment during the intervention (individuals with less than 80% compliance will be excluded from the study)
Show all 10Show fewer
- Preparation for pregnancy status during the dietary intervention
- Women with pacemakers or defibrillators implanted due to the theoretical possibility of interference with device activity due to the current field caused by impedance measurements
- Use of medication affecting carbohydrate or lipid metabolism in the last 6 months (oral contraceptive pills, insulin sensitizers, antiepileptics, antipsychotics, statins and fish oil)
- A psychiatric condition diagnosed by a physician It has been determined as a disease state.
Trial locations and contacts
1 site in 1 country.
About this study
Currently, there is still insufficient data to support the long-term efficacy, safety, and health benefits of time-restricted feeding models in women diagnosed with Polycystic ovary syndrome (PCOS), and further studies are needed to test and validate the effects of long-term dietary management in PCOS. On the other hand, similarly, studies investigating the effects of the Mediterranean Diet on body composition and dietary intake in women with PCOS are limited. The primary aim of this research is to examine the effect of time-restricted feeding and the Mediterranean diet model on body composition and dietary intake in adult women diagnosed with PCOS. The secondary aim is to evaluate the effect of different dietary models on quality of life in women diagnosed with PCOS.
Read the detailed description
PCOS is the most common female endocrine disorder and is characterized by chronic anovulation, hyperandrogenism, and polycystic ovaries.
The term PCOS was first used in 1935 when menstrual irregularities, decreased fertility, obesity, and hirsutism were reported in patients. Amenorrhea and resulting infertility, obesity, and male-pattern hair growth were listed among the symptoms. Diagnosis was made in the 1970s and 1980s by measuring luteinizing hormone (LH) levels.
At a conference organized by the National Institute of Health in 1990, it was stated that the primary diagnostic criteria for PCOS are infrequent ovulation and symptoms of androgen excess. Since 2003, PCOS has been diagnosed when at least two of the three Rotterdam criteria are present. Clinical hyperandrogenism (with hirsutism, acne, seborrhea, and alopecia) and/or high circulating androgen levels, the presence of ovarian cysts assessed by ultrasound examination, and anovulation and/or oligo-amenorrhea are criteria that lead to diagnosis. Various interventions (pharmacological, non-pharmacological, or surgical) exist to reduce PCOS symptoms. Metformin is a commonly used insulin sensitizer in PCOS patients with insulin resistance, but gastrointestinal side effects limit its use as a first-line treatment for long-term management. The international evidence-based guidelines for the assessment and management of PCOS, updated in 2018, recommend diet and exercise therapies as the first step in management. These guidelines focus on improving diagnostic accuracy by significantly improving individual diagnostic criteria; The focus is on reducing unnecessary testing; increasing emphasis on education, lifestyle changes, emotional well-being and quality of life; and highlighting evidence-based medical treatment and cheaper and safer fertility management.
Diet and exercise interventions are important because 60% of women with PCOS are overweight or obese. Recently, various dietary interventions are being tried for the management of PCOS. Fasting is known as one of the oldest traditions in the world and is practiced among various communities for cultural or religious reasons. Fasting has also been used as a method of treating diseases in the past. Hippocrates, considered the father of modern medicine, emphasized the importance of fasting during illness with his words, "To eat when you are sick is to feed your sickness". Intermittent fasting (IF), that is, periods of voluntary abstinence from food and drink, is known as an ancient practice followed in different forms by many populations worldwide. With intermittent fasting, there is a state of fasting or restricted eating at certain times of the day or on certain days of the week. IF; It can be implemented in three different types: alternate-day fasting, 5:2 diet, and time-restricted eating (TRF). Alternate-day fasting involves alternating days when food and drinks are consumed with fasting days when energy-containing foods or drinks are not consumed. In alternate-day fasting, approximately 20-25% of the energy requirement is met on fasting days. Modified fasting diet is also known as the 5:2 method. In this nutritional model, 2 non-consecutive days of the week involve a very low-calorie diet, while the other 5 days include normal energy requirements without energy restriction. Another approach is time-restricted eating, which is used to describe an eating pattern where food intake is limited to a time window of 8 hours or less each day. Among intermittent fasting diets, the TRF diet is a lifestyle intervention that limits the duration of food intake to a fixed number of hours. Welton et al. reported that the ideal fasting duration for positive weight change is 16 hours. In recent years, small-scale human studies demonstrating the importance of time-restricted eating have become widespread. Most of these studies have revealed the beneficial aspects of intermittent fasting in human metabolism, as in animal studies. With TRF, reductions in energy intake, body weight, body fat, blood sugar, triglycerides, glucose tolerance, and inflammatory markers have been observed. It has been found that IF may be beneficial in reducing body weight, improving insulin resistance, and reducing infection by regulating the circadian rhythm, gut microbial composition, and metabolism. Disruption in the circadian rhythm; Because it is associated with insulin resistance, excessive androgen production, increased Anti-Müllerian Hormone (AMH) levels, and apoptosis of granulosa cells, TRF is predicted to alleviate PCOS by improving the circadian rhythm. In addition, IF diets can improve PCOS by reducing insulin resistance through the stimulation of AMP-activated protein kinase (AMPK). In a recent review, it was found that in overweight/obese women with PCOS, the 5:2 diet and TRF promised improvements in menstrual regulation by significantly reducing the free androgen index and increasing sex hormone binding globulin. In a study in which 30 women diagnosed with PCOS underwent a 6-week, 8-hour TRF diet intervention, baseline (pre-diet) and post-diet findings were compared. It was found that after the diet, body mass index (BMI) and body weight decreased significantly, HOMA-IR improved significantly, and metabolic parameters related to glucose and lipid profiles also showed significant improvements after the diet. The Mediterranean diet is considered a health-promoting dietary model due to its unique characteristics, including regular consumption of unsaturated fats, low glycemic index carbohydrates, high amounts of fiber, vitamins, antioxidants, and moderate amounts of animal-derived proteins. In addition to weight loss, it has been reported to have anti-inflammatory activity due to the production of short-chain fatty acids stimulated by dietary fiber. The Mediterranean diet pyramid recommends foods to be consumed daily, weekly, and monthly. It is recommended that fish and seafood be consumed at least twice a week, white meat in 2 servings, eggs in 2-4 servings, red meat in less than 2 servings, processed meat in 1 serving or less, and desserts in less than 3 servings. Daily, it is recommended that dairy products be consumed in 2 servings, and olive oil-based seeds and nuts in 1-2 servings.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Mediterranean diet, intermittent fasting
- Keywords
- Mediterranean diet, intermittent fasting
- Medical subject headings
- Polycystic Ovary Syndrome, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean dietOther
Participants following the Mediterranean diet model will be informed about the Mediterranean diet pyramid, and the dietitian will plan how often and in what portions olive oil, nuts, olives, fish, yogurt, fruits, and vegetables they should consume. The Mediterranean diet pyramid recommends the daily, weekly, and monthly consumption frequencies of these foods. Weekly, it recommends consuming fish and seafood at least twice a week, 2 portions of white meat, 2-4 portions of eggs, less than 2 portions of red meat, 1 portion or less of processed meat, and less than 3 portions of sweets. Daily, it recommends 2 portions of dairy products, 1-2 portions of olive oil-based seeds and nuts, and more spices, herbs, garlic, and onions. It is also emphasized that each main meal should include 1-2 portions of fruit, more than 2 portions of vegetables, and 1-2 portions of olive oil and whole grains. Portion sizes are adjusted to individual needs and will be supported by food r
intermittent fastingOther
The women with PCOS included in the study will be randomly divided into two groups: one following the Mediterranean diet model and the other the intermittent fasting diet model. In randomized controlled trials, it is desirable for the number of participants in each group to be equal, balanced, and share similar characteristics. In this way, each participant will be included in any group with an equal and known probability. In the study, the assignment of participants to the groups will be done using a simple randomization method and a randomizer program (https://www.random.org/). The time-restricted eating (TRF) model will be applied. The time restriction will be planned as an 8-hour eating and 16-hour fasting period, suitable for the individuals' lifestyles. For individuals who agree to participate in the study, the eating times will be set as 11:00-12:00 and 19:00-20:00. It will be stated that the group applying the TRF model can drink non-energy beverages such as water, tea, and min
| Study group | Role | What they receive |
|---|---|---|
| Mediterranean diet group | Active comparator | Mediterranean diet Receives: Other: Mediterranean diet |
| intermittent fasting group | Active comparator | intermittent fasting Receives: Other: intermittent fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polycystic Ovary Syndrome Quality of Life-50 Scale (PCOSQ-50)
Consisting of 50 questions and 6 parameters, the scale's parameters are psychosocial and emotional status, fertility, sexual function, obesity and menstrual irregularity, hirsutism, and coping with the disease. The PCOSQ-50 scale is scored using a scale of always 1, frequently 2, sometimes 3, rarely 4, and never 5. Thus, the total score can range from 50 to 250 points. A lower score indicates a lower quality of life, while a higher score indicates less or no effect on quality of life. The Turkish validity and reliability study of the scale was conducted by Koyutürk (2018). The internal consistency coefficient (Cronbach's alpha) of the PCOSQ-50 scale is 0.972, and the internal consistency coefficients of the sub-dimensions range from 0.956 to 0.977. In this study, the Cronbach alpha value is 0.936.
Measured: 8 weeks
Secondary outcomes (10)
Body fat percentage (% fat)
Individuals' body weights and body compositions will be measured using foot-to-foot bioelectrical impedance analysis (BIA). Body fat percentage (% fat) will be measured using a TANITA MC 580.
Measured: 8 weeks
Body mass index (BMI)
Body mass index (BMI) will be calculated using the equation where body weight is divided by the square of height in meters, and will be evaluated according to the World Health Organization's classification for adults.
Measured: 8 weeks
blood glucose (mg/dL)
All participants included in the study will be informed that they can return to their primary care physician at the end of the 8th week for an evaluation of their medical nutrition therapy, and their biochemical findings will be recorded on the research form. Since all primary care physicians in the same province have routine biochemical tests performed at the same reference laboratory, all results obtained retrospectively from patients are standardized. No invasive procedures will be performed specifically for this research. No biochemical tests specific to this study will be conducted; only the results of routine biochemical tests already performed within the scope of patients' basic health care will be used as data. Fasting blood glucose (mg/dL) values of individuals participating in the study will be recorded retrospectively on the data collection form before the diet and after the 8th week.
Measured: 8 weeks
weight
Individuals' body weights and body compositions will be measured using foot-to-foot bioelectrical impedance analysis (BIA). Weight will be measured in kilograms and the measurement will be performed using a TANITA MC 580 device.
Measured: 8 weeks
Serum insulin (μIU/mL)
All participants included in the study will be informed that they can revisit their primary care physician at the end of the 8th week for an evaluation of their medical nutrition therapy, and their biochemical findings will be recorded on the research form. Since all primary care physicians in the same province have routine biochemical tests performed at the same reference laboratory, all results obtained retrospectively from patients are standardized. No invasive procedures will be performed specifically for this research. No biochemical tests specific to this study will be conducted; only the results of routine biochemical tests already performed within the scope of patients' basic health care will be used as data. Serum insulin (μIU/mL) values of individuals participating in the study will be recorded retrospectively on the data collection form before the diet and after the 8th week.
Measured: 8 weeks
HbA1C (%)
All participants in the study will be informed that they can revisit their primary care physician at the end of the 8th week for an evaluation of their medical nutrition therapy, and their biochemical findings will be recorded on the research form. Since all primary care physicians in the same province perform routine biochemical tests at the same reference laboratory, all results obtained retrospectively from patients are standardized. No invasive procedures will be performed specifically for this research. No biochemical tests specific to this study will be conducted; only the results of routine biochemical tests already performed within the scope of basic health care will be used as data. The HbA1C (%) values of the individuals participating in the study will be recorded retrospectively on the data collection form before the diet and after the 8th week.
Measured: 8 weeks
Total Cholesterol (mg/dL)
All participants included in the study will be informed that they can revisit their primary care physician at the end of the 8th week for an evaluation of their medical nutritional therapy, and their biochemical findings will be recorded on the research form. Since all primary care physicians in the same province perform routine biochemical tests at the same reference laboratory, all results obtained retrospectively from patients are standardized. No invasive procedures will be performed specifically for this research. No biochemical tests specific to this study will be conducted; only the results of routine biochemical tests already performed within the scope of patients' basic health care will be used as data. Total Cholesterol (mg/dL) values of individuals participating in the study will be recorded retrospectively on the data collection form before the diet and after the 8th week.
Measured: 8 weeks
LDL (mg/dL)
All participants included in the study will be informed that they can revisit their primary care physician at the end of the 8th week for an evaluation of their medical nutrition therapy, and their biochemical findings will be recorded on the research form. Since all primary care physicians in the same province perform routine biochemical tests at the same reference laboratory, all results obtained retrospectively from patients are standardized. No invasive procedures will be performed specifically for this research. No biochemical tests specific to this study will be conducted; only the results of routine biochemical tests already performed within the scope of patients' basic health care will be used as data. LDL (mg/dL) values of individuals participating in the study will be recorded retrospectively on the data collection form before the diet and after the 8th week.
Measured: 8 weeks
HDL (mg/dL)
All participants included in the study will be informed that they can revisit their primary care physician at the end of the 8th week for an evaluation of their medical nutrition therapy, and their biochemical findings will be recorded on the research form. Since all primary care physicians in the same province perform routine biochemical tests at the same reference laboratory, all results obtained retrospectively from patients are standardized. No invasive procedures will be performed specifically for this research. No biochemical tests specific to this study will be conducted; only the results of routine biochemical tests already performed within the scope of patients' basic health care will be used as data. The HDL (mg/dL) values of the individuals participating in the study will be recorded retrospectively on the data collection form before the diet and after the 8th week.
Measured: 8 weeks
Triglyceride (mg/dL)
All participants included in the study will be informed that they can revisit their primary care physician at the end of the 8th week for an evaluation of their medical nutritional therapy, and their biochemical findings will be recorded on the research form. Since all primary care physicians in the same province perform routine biochemical tests at the same reference laboratory, all results obtained retrospectively from patients are standardized. No invasive procedures will be performed specifically for this research. No biochemical tests specific to this study will be conducted; only the results of routine biochemical tests already performed within the scope of patients' basic health care will be used as data. Triglyceride (mg/dL) values of individuals participating in the study will be recorded retrospectively on the data collection form before the diet and after the 8th week.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start2 Jan 2026
- Primary completion30 Jan 2026
- Study completion20 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study sample consists of women in Konya province who applied to the Healthy Living Center after a physician evaluation and were diagnosed with PCOS. To determine the number of participants, the GPower 3.1.9.7 power analysis program requires the inclusion of a total of 56 women, with at least 28 women in each group, using 80% power and a 0.05 margin of error (actual power = 0.8037085). Since the study is planned in a longitudinal-randomized controlled design, a total of 62 participants will be included, with 31 women in each group, taking into account a 10% dropout rate.
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SUHİDE BİLGE HORZUM, Selcuk University
- Investigators
- Melda Kangalgil, Principal investigator, Cumhuriyet UniversityAyşe N Kahve, Principal investigator, Aksaray University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07385716
- Sponsor's protocol ID
- 2025-12/51
- Acronym
- PCOS
- Status last verified
- Apr 2026
- First submitted
- 17 Jan 2026
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Polycystic Ovary Syndrome Quality of Life-50 Scale (PCOSQ-50) Biochemical Parameters Anthropometric Measurements
Publications
Barrea L, Arnone A, Annunziata G, Muscogiuri G, Laudisio D, Salzano C, Pugliese G, Colao A, Savastano S. Adherence to the Mediterranean Diet, Dietary Patterns and Body Composition in Women with Polycystic Ovary Syndrome (PCOS). Nutrients. 2019 Sep 23;11(10):2278. doi: 10.3390/nu11102278.
PubMed 31547562
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Time-Restricted Feeding and Mediterranean Diet Model in Women With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT07385716
- Acronym / sponsor ID
- PCOS / 2025-12/51
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- Mediterranean diet, intermittent fasting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 2 Jan 2026 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 20 Apr 2026 (actual)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Currently, there is still insufficient data to support the long-term efficacy, safety, and health benefits of time-restricted feeding models in women diagnosed with Polycystic ovary syndrome (PCOS), and further studies are needed to test and validate the effects of long-term dietary management in PCOS. On the other hand, similarly, studies investigating the effects of the Mediterranean Diet on body composition and dietary intake in women with PCOS are limited. The primary aim of this research is to examine the effect of time-restricted feeding and the Mediterranean diet model on body composition and dietary intake in adult women diagnosed with PCOS. The secondary aim is to evaluate the effect of different dietary models on quality of life in women diagnosed with PCOS.
Detailed description
PCOS is the most common female endocrine disorder and is characterized by chronic anovulation, hyperandrogenism, and polycystic ovaries.
The term PCOS was first used in 1935 when menstrual irregularities, decreased fertility, obesity, and hirsutism were reported in patients. Amenorrhea and resulting infertility, obesity, and male-pattern hair growth were listed among the symptoms. Diagnosis was made in the 1970s and 1980s by measuring luteinizing hormone (LH) levels.
At a conference organized by the National Institute of Health in 1990, it was stated that the primary diagnostic criteria for PCOS are infrequent ovulation and symptoms of androgen excess. Since 2003, PCOS has been diagnosed when at least two of the three Rotterdam criteria are present. Clinical hyperandrogenism (with hirsutism, acne, seborrhea, and alopecia) and/or high circulating androgen levels, the presence of ovarian cysts assessed by ultrasound examination, and anovulation and/or oligo-amenorrhea are criteria that lead to diagnosis. Various interventions (pharmacological, non-pharmacological, or surgical) exist to reduce PCOS symptoms. Metformin is a commonly used insulin sensitizer in PCOS patients with insulin resistance, but gastrointestinal side effects limit its use as a first-line treatment for long-term management. The international evidence-based guidelines for the assessment and management of PCOS, updated in 2018, recommend diet and exercise therapies as the first step in management. These guidelines focus on improving diagnostic accuracy by significantly improving individual diagnostic criteria; The focus is on reducing unnecessary testing; increasing emphasis on education, lifestyle changes, emotional well-being and quality of life; and highlighting evidence-based medical treatment and cheaper and safer fertility management.
Diet and exercise interventions are important because 60% of women with PCOS are overweight or obese. Recently, various dietary interventions are being tried for the management of PCOS. Fasting is known as one of the oldest traditions in the world and is practiced among various communities for cultural or religious reasons. Fasting has also been used as a method of treating diseases in the past. Hippocrates, considered the father of modern medicine, emphasized the importance of fasting during illness with his words, "To eat when you are sick is to feed your sickness". Intermittent fasting (IF), that is, periods of voluntary abstinence from food and drink, is known as an ancient practice followed in different forms by many populations worldwide. With intermittent fasting, there is a state of fasting or restricted eating at certain times of the day or on certain days of the week. IF; It can be implemented in three different types: alternate-day fasting, 5:2 diet, and time-restricted eating (TRF). Alternate-day fasting involves alternating days when food and drinks are consumed with fasting days when energy-containing foods or drinks are not consumed. In alternate-day fasting, approximately 20-25% of the energy requirement is met on fasting days. Modified fasting diet is also known as the 5:2 method. In this nutritional model, 2 non-consecutive days of the week involve a very low-calorie diet, while the other 5 days include normal energy requirements without energy restriction. Another approach is time-restricted eating, which is used to describe an eating pattern where food intake is limited to a time window of 8 hours or less each day. Among intermittent fasting diets, the TRF diet is a lifestyle intervention that limits the duration of food intake to a fixed number of hours. Welton et al. reported that the ideal fasting duration for positive weight change is 16 hours. In recent years, small-scale human studies demonstrating the importance of time-restricted eating have become widespread. Most of these studies have revealed the beneficial aspects of intermittent fasting in human metabolism, as in animal studies. With TRF, reductions in energy intake, body weight, body fat, blood sugar, triglycerides, glucose tolerance, and inflammatory markers have been observed. It has been found that IF may be beneficial in reducing body weight, improving insulin resistance, and reducing infection by regulating the circadian rhythm, gut microbial composition, and metabolism. Disruption in the circadian rhythm; Because it is associated with insulin resistance, excessive androgen production, increased Anti-Müllerian Hormone (AMH) levels, and apoptosis of granulosa cells, TRF is predicted to alleviate PCOS by improving the circadian rhythm. In addition, IF diets can improve PCOS by reducing insulin resistance through the stimulation of AMP-activated protein kinase (AMPK). In a recent review, it was found that in overweight/obese women with PCOS, the 5:2 diet and TRF promised improvements in menstrual regulation by significantly reducing the free androgen index and increasing sex hormone binding globulin. In a study in which 30 women diagnosed with PCOS underwent a 6-week, 8-hour TRF diet intervention, baseline (pre-diet) and post-diet findings were compared. It was found that after the diet, body mass index (BMI) and body weight decreased significantly, HOMA-IR improved significantly, and metabolic parameters related to glucose and lipid profiles also showed significant improvements after the diet. The Mediterranean diet is considered a health-promoting dietary model due to its unique characteristics, including regular consumption of unsaturated fats, low glycemic index carbohydrates, high amounts of fiber, vitamins, antioxidants, and moderate amounts of animal-derived proteins. In addition to weight loss, it has been reported to have anti-inflammatory activity due to the production of short-chain fatty acids stimulated by dietary fiber. The Mediterranean diet pyramid recommends foods to be consumed daily, weekly, and monthly. It is recommended that fish and seafood be consumed at least twice a week, white meat in 2 servings, eggs in 2-4 servings, red meat in less than 2 servings, processed meat in 1 serving or less, and desserts in less than 3 servings. Daily, it is recommended that dairy products be consumed in 2 servings, and olive oil-based seeds and nuts in 1-2 servings.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study sample consists of women in Konya province who applied to the Healthy Living Center after a physician evaluation and were diagnosed with PCOS. To determine the number of participants, the GPower 3.1.9.7 power analysis program requires the inclusion of a total of 56 women, with at least 28 women in each group, using 80% power and a 0.05 margin of error (actual power = 0.8037085). Since the study is planned in a longitudinal-randomized controlled design, a total of 62 participants will be included, with 31 women in each group, taking into account a 10% dropout rate.
| Arm | Type | Receives |
|---|---|---|
| Mediterranean diet group | Active comparator | Other: Mediterranean dietMediterranean diet |
| intermittent fasting group | Active comparator | Other: intermittent fastingintermittent fasting |
Who may qualify
- Ages
- 20 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Being between 20-49 years of age
- Having been diagnosed with PCOS by a specialist according to Rotterdam criteria
- Having a BMI between 25-35 kg/m2
- Not having any conditions that impair reality testing and cognitive functions, preventing interviews or completing scales
- Being literature
Key exclusion criteria (10 listed)
- Combination of other endocrine etiological disorders according to Rotterdam criteria (congenital adrenal hyperplasia, Cushing syndrome, androgen-secreting tumors, hyperprolactinemia, thyroid, adrenal and other endocrine disorders)
- Combination of cardiovascular and cerebrovascular diseases, hematological disorders, hepatic and renal failure and other serious diseases
- Liver and kidney disease
- Use of insulin or oral antidiabetic drugs,
- Being pregnant and lactating
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mediterranean dietParticipants following the Mediterranean diet model will be informed about the Mediterranean diet pyramid, and the dietitian will plan how often and in what portions olive oil, nuts, olives, fish, yogurt, fruits, and vegetables they should consume. The Mediterranean diet pyramid recommends the daily, weekly, and monthly consumption frequencies of these foods. Weekly, it recommends consuming fish and seafood at least twice a week, 2 portions of white meat, 2-4 portions of eggs, less than 2 portions of red meat, 1 portion or less of processed meat, and less than 3 portions of sweets. Daily, it recommends 2 portions of dairy products, 1-2 portions of olive oil-based seeds and nuts, and more spices, herbs, garlic, and onions. It is also emphasized that each main meal should include 1-2 portions of fruit, more than 2 portions of vegetables, and 1-2 portions of olive oil and whole grains. Portion sizes are adjusted to individual needs and will be supported by food r | Other | Mediterranean diet group |
| intermittent fastingThe women with PCOS included in the study will be randomly divided into two groups: one following the Mediterranean diet model and the other the intermittent fasting diet model. In randomized controlled trials, it is desirable for the number of participants in each group to be equal, balanced, and share similar characteristics. In this way, each participant will be included in any group with an equal and known probability. In the study, the assignment of participants to the groups will be done using a simple randomization method and a randomizer program (https://www.random.org/). The time-restricted eating (TRF) model will be applied. The time restriction will be planned as an 8-hour eating and 16-hour fasting period, suitable for the individuals' lifestyles. For individuals who agree to participate in the study, the eating times will be set as 11:00-12:00 and 19:00-20:00. It will be stated that the group applying the TRF model can drink non-energy beverages such as water, tea, and min | Other | intermittent fasting group |
Primary outcome
Polycystic Ovary Syndrome Quality of Life-50 Scale (PCOSQ-50)
Time frame: 8 weeks
Consisting of 50 questions and 6 parameters, the scale's parameters are psychosocial and emotional status, fertility, sexual function, obesity and menstrual irregularity, hirsutism, and coping with the disease. The PCOSQ-50 scale is scored using a scale of always 1, frequently 2, sometimes 3, rarely 4, and never 5. Thus, the total score can range from 50 to 250 points. A lower score indicates a lower quality of life, while a higher score indicates less or no effect on quality of life. The Turkish validity and reliability study of the scale was conducted by Koyutürk (2018). The internal consistency coefficient (Cronbach's alpha) of the PCOSQ-50 scale is 0.972, and the internal consistency coefficients of the sub-dimensions range from 0.956 to 0.977. In this study, the Cronbach alpha value is 0.936.
10 secondary outcomes
Body fat percentage (% fat)
Time frame: 8 weeks
Body mass index (BMI)
Time frame: 8 weeks
blood glucose (mg/dL)
Time frame: 8 weeks
weight
Time frame: 8 weeks
Serum insulin (μIU/mL)
Time frame: 8 weeks
HbA1C (%)
Time frame: 8 weeks
Total Cholesterol (mg/dL)
Time frame: 8 weeks
LDL (mg/dL)
Time frame: 8 weeks
HDL (mg/dL)
Time frame: 8 weeks
Triglyceride (mg/dL)
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Results publication: PubMed 31547562Barrea L, Arnone A, Annunziata G, Muscogiuri G, Laudisio D, Salzano C, Pugliese G, Colao A, Savastano S. Adherence to the Mediterranean Diet, Dietary Patterns and Body Composition in Women with Polycystic Ovary Syndrome (PCOS). Nutrients. 2019 Sep 23;11(10):2278. doi: 10.3390/nu11102278.
- Individual participant dataSharing planned: Yes. Polycystic Ovary Syndrome Quality of Life-50 Scale (PCOSQ-50) Biochemical Parameters Anthropometric Measurements
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melda Kangalgil principal investigator
Cumhuriyet University
Ayşe N Kahve principal investigator
Aksaray University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mediterranean diet and intermittent fasting in people with Polycystic Ovary Syndrome, run by Selcuk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Polycystic Ovary Syndrome Quality of Life-50 Scale (PCOSQ-50) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07385716, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.