Time Restricted Feeding Model in Women With Polycystic Ovary Syndrome

Summary

This study aims to evaluate the effects of a 16:8 time-restricted feeding (TRF) model on anthropometric, metabolic, and hormonal parameters in women with polycystic ovary syndrome (PCOS). In addition, the study will assess participants' food preferences, nutrient intake, and gastrointestinal hormone responses, alongside serum glucose, insulin, and glucagon levels, during ad libitum breakfast meals served at the beginning and end of the intervention.

The study consists of three groups: women with PCOS following a 16:8 TRF model for 12 weeks, women with PCOS following an energy-restricted diet for 12 weeks, and healthy women following a 16:8 TRF model for 12 weeks. Women aged 18-40, with PCOS based on the Rotterdam criteria, will be included in the PCOS groups, while those without PCOS-related symptoms will form the control group. Exclusion criteria include pregnancy, lactation, use of hormonal medications, and the presence of comorbidities such as diabetes or severe liver/kidney dysfunction.

Participants in the TRF groups will consume their daily caloric intake within an 8-hour eating window, fasting for the remaining 16 hours, while the energy-restricted group will follow a balanced diet without timing restrictions. Adherence to the dietary interventions will be monitored through weekly 24-hour dietary records. At baseline, participants will complete a demographic questionnaire, receive nutritional education for their nutritional plan, and undergo assessments for anthropometric and blood pressure measurements, sleep quality, food cravings, and physical activity. Biochemical analyses will evaluate thyroid and sex hormones, electrolytes, liver enzymes, lipid profiles, and hemograms. Additionally, all participants will wear smart wristbands (FitBit Charge 5) throughout the study to track sleep and physical activity.

At the beginning and end of the study, participants will consume a standardized ad libitum breakfast meal during the early follicular phase (days 2-5 of menstrual bleeding). Participants will have 30 minutes to eat as much as they wish, and their consumption will be recorded by a dietitian. The nutrient content of the consumed foods will be analyzed using the Nutrition Information System (BEBIS) software. Blood samples will be collected and visual analogue scala (VAS) will be filled at fasting and at 30, 60, 90, and 120 minutes post-meal. Serum glucose, insulin, glucagon, ghrelin, and incretin hormones will be analyzed using the enzyme-linked immunosorbent analysis (ELISA) method.

Data analysis will be performed using SPSS 23.0 via appropriate statistically analysis. Statistical significance is set at p\<0.05.

Conditions

• Polycystic Ovarian Syndrome (PCOS)

Interventions

OTHER

Dietary Intervention (time-restricted feeding model (16:8))

Time-Restricted Feeding (16:8 model): Participants can consume food in any amount during an 8-hour window (08:00-16:00), but no food or energy-containing drinks are allowed during the remaining 16-hour fasting period.

OTHER

Dietary Intervention (energy restricted dietary intervention)

Participants' daily energy needs are calculated based on their basal metabolic rate and physical activity. The energy intake is then reduced by 15-25%. The diet plan consists of 3 main meals and 2-3 snacks, with the daily intake of carbohydrates, proteins, and fats making up 50-60%, 15-20%, and 25-30% of the total daily energy, respectively.

Sponsors & Collaborators

• Hacettepe University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

19 Years

Max Age

35 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-10-01

Primary Completion

2026-03-01

Completion

2026-07-30