Effects of a Specific Dietary Program on Overweight/Obese Women With Polycystic Ovary Syndrome: A Multicenter, Prospective, Randomized Controlled Clinical Study

Overview

The goal of this clinical trial is to investigate the effects of a specific dietary program on overweight or obese patients with polycystic ovary syndrome (PCOS) through a multicenter, randomized, controlled, prospective study design. The main questions it aims to answer are: 1. Does the specific dietary program increase the clinical remission rate of PCOS in overweight or obese patients? 2. Does the specific dietary program improve metabolic and anthropometric outcomes in overweight or obese patients with PCOS compared with conventional intervention? Researchers will compare the effects of a specific dietary program versus conventional intervention on clinical remission rates, metabolic outcomes, and anthropometric measures in overweight or obese patients with PCOS. Participants will: 1. Receive either a specific dietary intervention or conventional intervention for 24 weeks. 2. Undergo assessments every 12 weeks throughout the study period.

Interventions

• Behavioral Specific dietary intervention group
  1. Energy Levels and Individualized Matching The dietary intervention includes three energy levels: 1200 kcal, 1400 kcal, and 1600 kcal. Based on height, weight, basal metabolic rate, and weight loss goals, participants are matched to the appropriate energy level. The nutrition team will adjust the energy level and dietary plan every 4 weeks based on weight changes and metabolic feedback, with the intervention continuing for 24 weeks. 2. Nutritional Composition and Base Formula Design The plan c
• Behavioral Conventional intervention
  The dietary intervention involves a 20% reduction in total caloric intake, with a balanced distribution of nutrients to ensure adequate intake of essential macronutrients and micronutrients. The intervention will be implemented over a period of 24 weeks.

Primary outcome measures

• Clinical remission rate of PCOS [Time frame: Baseline and Week 24]

Secondary outcome measures (12)

• Waist circumference [Time frame: Baseline, Week 12, and Week 24]
• Blood pressure [Time frame: Baseline, Week 12, and Week 24]
• Weight [Time frame: Baseline, Week 12, and Week 24]
• Body fat percentage [Time frame: Baseline, Week 12, and Week 24]
• Skeletal muscle mass [Time frame: Baseline, Week 12, and Week 24]
• Basal metabolic rate [Time frame: Baseline, Week 12, and Week 24]
• Serum anti-Müllerian hormone (AMH) concentration [Time frame: Baseline and Week 24]
• Progesterone [Time frame: Baseline and Week 24]
• Fasting plasma glucose [Time frame: Baseline and Week 24]
• Fasting insulin [Time frame: Baseline and Week 24]
• Total cholesterol [Time frame: Baseline and Week 24]
• Low-density lipoprotein cholesterol [Time frame: Baseline and Week 24]

Eligibility criteria

Inclusion criteria

• Female participants aged 18-49 years.
• Body mass index (BMI) ≥ 24 kg/m² and waist circumference ≥ 85 cm.
• Diagnosis of polycystic ovary syndrome (PCOS) based on the 2003 Rotterdam consensus, defined by the presence of at least two of the following three criteria: (i) Oligo-ovulation and/or anovulation; (ii) Clinical and/or biochemical signs of hyperandrogenism; (iii) Polycystic ovarian morphology on ultrasonography, defined as the presence of ≥12 follicles measuring 2-9 mm in diameter in each ovary and/or increased ovarian volume ≥10 cm³.
• Menstrual irregularity.
• Use of reliable non-hormonal contraception throughout the study period.
• Provision of written informed consent.

Exclusion criteria

• Participants with non-classical 21-hydroxylase deficiency, hyperprolactinemia, Cushing's disease, or adrenal tumors will be excluded from the study.
• Participants who are postmenopausal or perimenopausal, as well as those who are pregnant, planning pregnancy, or currently lactating, will be excluded.
• Participants with a history of substance abuse, acute infectious diseases, or diabetes mellitus will not be eligible for inclusion.
• Participants with a history of malignancy within the past 5 years or with current malignant disease will be excluded.
• Participants with a history of gallstones or gout will be excluded from the study.
• Participants with poorly controlled thyroid disorders, regardless of etiology, will be excluded.
• Participants who have been diagnosed with an eating disorder within the past 12 months will be excluded.
• Participants with known intolerance or allergy to components of the study dietary plan, such as soy, lactose, or gluten, or those diagnosed with celiac disease, will be excluded.
• Participants who have used medications that may affect reproductive or metabolic outcomes within the past 3 months will be excluded, including oral hormonal contraceptives or hormonal implants; anti-androgens (e.g., spironolactone, flutamide, finasteride); metformin or other insulin-sensitizing agents; clomiphene citrate or estrogen modulators; gonadotropin-releasing hormone (GnRH) modulators (e.g., leuprolide); minoxidil; weight-loss medications; or other drugs that may influence appetite, such as oral corticosteroids.
• Participants with severe hepatic impairment, defined as alanine aminotransferase (ALT) > 100 U/L or aspartate aminotransferase (AST) > 100 U/L, will be excluded.
• Participants with severe renal impairment, defined as an estimated glomerular filtration rate (eGFR) < 80 mL/min, will be excluded.
• Participants with severe cardiovascular or cerebrovascular disease, including unstable angina, heart failure classified as New York Heart Association (NYHA) class III or higher, or those in the acute phase of cerebral infarction, will be excluded.
• Participants who are currently participating in another clinical trial will be excluded.
• Participants with any other medical condition or circumstance that, in the opinion of the investigators, makes them unsuitable for participation will be excluded.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

China · 1 center

• Xuanwu Hospital, Capital Medical University — Beijing

Identifiers

NCT: NCT07350889 · [2025]438-002

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗