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

Обзор

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.

Вмешательства

• Поведенческое 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
• Поведенческое 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.

Первичные конечные точки

• Clinical remission rate of PCOS [Срок оценки: Baseline and Week 24]

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Xuanwu Hospital, Capital Medical University — Пекин

Идентификаторы

NCT: NCT07350889 · [2025]438-002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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