Time Restricted Feeding Model in Women With Polycystic Ovary Syndrome

NCT06807775 | Not Yet Recruiting

• 2 other identifiers: 24-AKD-28TSA-2024-21146
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief 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)

Keywords

Polycystic ovary syndrome; 16:8 time-restricted feeding; metabolic risk factors; appetite regulation; obesity

Outcome Measures

Primary Outcomes (3)

• Changes in body mass index (BMI)

  BMI will be calculated using weight (kg) and height (m²). Weight and height will be measured separately and used to derive BMI as a single reported outcome.

  Beginning of the experiment (week 0), 2nd, 4th, 6th, 8th, 10th study weeks and end of the experiment for each participants (week 12).

• Changes in serum fasting glucose and lipit profile

  Changes in fasting glucose, triglycerides, total cholesterol, low density lipoprotein-cholesterol, and high density lipoprotein-cholesterol (HDL-C) levels will be measured via enzymatic biochemical analysis. All values will be reported in millimolar (mM) and analyzed collectively as metabolic biomarkers.

  Beginning of the experiment (week 0) and end of the experiment for each participants (12th study week)

• Changes in appetite-related hormones (insulin, glucagon, ghrelin, glucagon-like peptid-1, and gastric inhibitory peptide)

  Changes in insulin, glucagon, ghrelin, glucagon-like peptide-1, and gastric inhibitory peptide levels will be measured via enzyme-linked immunosorbent assay (ELISA kits). All values will be reported in nanomolar (nM) and analyzed collectively as appetite-regulating hormones.

  At both the beginning (week 0) and completion of the experiment for each participant (12th study week) , measurements were taken at the start of the open buffet breakfast and subsequently at the 30th, 60th, 90th, and 120th minutes.

Secondary Outcomes (6)

• Food craving

  Beginning (week 0), week 2, 4, 6, 8, 10, and end of the study (week 12)

• Sleep quality

  Beginning (week 0), week 2, 4, 6, 8, 10, and end of the study (week 12)

• Physical activity

  Beginning (week 0), week 2, 4, 6, 8, 10, and end of the study (week 12)

• Change in daily energy intake

  0-12 weeks

• Blood pressure

  Beginning (week 0), week 2, 4, 6, 8, 10, and end of the study (week 12)

Study Arms (3)

PCOS+TRF

EXPERIMENTAL

Women with PCOS following time-restricted feeding model (16:8) for 12 weeks

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

PCOS+ER

EXPERIMENTAL

Women with PCOS following energy-restricted diet for 12 weeks

Other: Dietary Intervention (energy restricted dietary intervention)

Control+TRF

EXPERIMENTAL

Healthy women following time-restricted feeding model (16:8) for 12 weeks

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

Interventions

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

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.

Also known as: Dietary Intervention (Energy Restricted Diet)

Control+TRF; PCOS+TRF

Dietary Intervention (energy restricted dietary intervention) OTHER

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.

PCOS+ER

Eligibility Criteria

• Age: 19 Years - 35 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• For study groups of women diagnosed with polycystic ovary syndrome (PCOS)
• Aged between 19 and 35 years, with a diagnosis of PCOS
• No chronic diseases diagnosed by a physician, other than PCOS
• Body mass index (BMI) between 25 and 40 kg/m²
• No use of oral contraceptives, insulin sensitizers, or anti-androgen medications in the last three months
• For the healthy control group
• Aged between 19 and 35 years
• No diagnosis of chronic diseases
• Body mass index (BMI) between 25 and 40 kg/m²
• No use of oral contraceptives, insulin sensitizers, or anti-androgen medications in the last three months

You may not qualify if:

• For all study groups:
• Being in the menopause, pregnancy, or lactation period
• Having a diagnosis of any chronic disease (e.g., hypertension, diabetes mellitus, cardiovascular disease, etc.) other than PCOS, as determined by a physician
• Having hyperprolactinemia, congenital adrenal hyperplasia, androgen-secreting tumors, thyroid disorders, Cushing's syndrome, hepatic or renal dysfunction
• Using antihyperlipidemic, antihypertensive, or glucocorticoid medications
• Following any specific dietary treatment

Sponsors & Collaborators

• Hacettepe University: lead

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Obesity

Interventions

Diet Therapy

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; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Central Study Contacts

Aylin Acikgoz Pinar, Assoc. Prof. Dr.

CONTACT

+90312 3051094; aylinn@hacettepe.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Proffessor Doctor

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: February 4, 2025
• Study Start: October 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: September 10, 2025

Record last verified: 2025-01