Polycystic ovary syndrome
Conditions
Interventions
Time-Restricted Eating group:Time-Restricted Eating 10h
Continuous energy restriction group:Continuous energy restriction
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
Female
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-40 years; 2. Meet the diagnostic criteria of PCOS in 2003 Rotterdam diagnostic criteria; 3. BMI>= 24kg/m^2; 4. Stable weight (weight fluctuation < 5% in the first 3 months); 5. Have the ability to understand the diet management plan and voluntarily participate in the whole process of diet management, and sign the informed consent; 6. Be able to follow the management of doctors or nutritionists.
Exclusion criteria
Exclusion criteria: 1. Clinically diagnosed with diabetes mellitus; 2. Presence of endocrine disorders other than PCOS (e.g., congenital adrenal hyperplasia, Cushing's syndrome, androgen-secreting tumors, hyperprolactinemia, thyroid disorders, premature ovarian insufficiency, etc.) that are under treatment and uncontrolled; 3. Use of oral contraceptives, non-progesterone hormonal medications, insulin sensitizers (e.g., metformin, pioglitazone), antihypertensive drugs, or other medications affecting lipid metabolism (e.g., statins, fish oil) within the past 3 months; 4. Use of medications affecting body weight (e.g., orlistat, glucocorticoids) or influencing appetite or gastrointestinal motility within the past 3 months; 5. Severe liver dysfunction (ALT = 3 × ULN); severe renal impairment (eGFR = 60 mL/min/1.73 m^2); 6. Alcohol consumption equivalent to > 70 g of ethanol per week; 7. Heart failure (NYHA class III–IV); 8. Severe hematological disorders (e.g., thalassemia, iron deficiency anemia, etc.); 9. Psychiatric disorders that preclude compliance with the trial; history of malignancy within the past 5 years; 10. Inability to consume food orally; history of gastrointestinal surgery; use of antibiotics, hypoglycemic agents, corticosteroids, beta-blockers, beta-agonists, proton pump inhibitors (PPIs), laxatives, ACE inhibitors, selective serotonin reuptake inhibitor (SSRI) antidepressants, acetaminophen, or other medications that may influence study endpoints within the past 3 months; consumption of probiotic-containing foods within the past week; 11. Intolerance or allergy to components of the protein bar; 12. Individuals prone to recurrent hypoglycemia as judged by the investigator; 13. Individuals planning pregnancy, pregnant women, or breastfeeding women; 14. Shift workers or individuals with unstable sleep patterns; 15. Participation in other clinical trials within the past 3 months prior to screening, or adherence to special diets (e.g., vegetarian, ketogenic diet, etc.), or following TRE (Time-Restricted Eating), IER (Intermittent Energy Restriction), or CER (Continuous Energy Restriction) dietary patterns.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight; | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood glucose;Pancreatic islet function;Sex hormone;Body fat distribution;Intestinal microbiota;Quality of life;Utero-ovarian ultrasound;Menstrual cycle;Quality of life;Liver enzymes;Uric acid;Lipids;Inflammatory cytokines;Waist circumference;Hip circumference;Weight; Insulin sensitivity-related indicators; | — |
Countries
China
Contacts
Public ContactZhang Haohao
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed