RecruitingNot ApplicableNCT07385716

Evaluation of the Effect of Time-Restricted Feeding and Mediterranean Diet Model in Women With Polycystic Ovary Syndrome

Sponsor

Selcuk University

Enrollment

62 participants

Start Date

Jan 2, 2026

Study Type

INTERVENTIONAL

Conditions

Polycystic Ovary Syndrome

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. 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.

Eligibility

Sex: FEMALEMin Age: 20 YearsMax Age: 49 Years

Inclusion Criteria6

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.

Exclusion Criteria10

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)
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.

Interventions

OTHERMediterranean diet

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

OTHERintermittent fasting

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