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

NCT07385716 | Completed

• 1 other identifier: 2025-12/51
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Polycystic Ovary Syndrome

Keywords

Mediterranean diet; intermittent fasting

Outcome Measures

Primary Outcomes (1)

• 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.

  8 weeks

Secondary Outcomes (10)

• Body fat percentage (% fat)

  8 weeks

• Body mass index (BMI)

  8 weeks

• blood glucose (mg/dL)

  8 weeks

• weight

  8 weeks

• Serum insulin (μIU/mL)

  8 weeks

Study Arms (2)

Mediterranean diet group

ACTIVE COMPARATOR

Mediterranean diet

Other: Mediterranean diet

intermittent fasting group

ACTIVE COMPARATOR

intermittent fasting

Other: intermittent fasting

Interventions

Mediterranean diet OTHER

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

Mediterranean diet group

intermittent fasting OTHER

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

intermittent fasting group

Eligibility Criteria

• Age: 20 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (1)

Healthy Life Center

Konya, Selçuklu, 42100, Turkey (Türkiye)

Location

Related Publications (1)

• Barrea, L., Arnone, A., Annunziata, G., Muscogiuri, G., Laudisio, D., Salzano, C., Pugliese, G., Colao, A., & Savastano, S. (2019). Adherence to the Mediterranean diet, dietary patterns and body composition in women with polycystic ovary syndrome (PCOS). Nutrients, 11(10), 2278

  RESULT

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Intermittent Fasting

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Fasting; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Melda Kangalgil

  Cumhuriyet University

  PRINCIPAL INVESTIGATOR

• Ayşe N Kahve

  Aksaray University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dietitian

Model Details: 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.

Study Record Dates

• First Submitted: January 17, 2026
• First Posted: February 4, 2026
• Study Start: January 2, 2026
• Primary Completion: January 30, 2026
• Study Completion: April 20, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: January 2026 - March 2026
• Access Criteria: The aim is to benefit society by publishing the study results at the end of the study.

Locations

TU (1)