Tests a specific diet in overweight or obese women with polycystic ovary syndrome
Compares a specific diet with conventional care in overweight women with polycystic ovary syndrome.
Plain-language title generated from the registry record
Registry title: Effects of a Specific Dietary Program on Overweight/Obese Women With Polycystic Ovary Syndrome: A Multicenter, Prospective, Randomized Controlled Clinical Study
Key facts
- Where
- Beijing, ChinaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women aged 18-49 with polycystic ovary syndrome (PCOS) who are overweight or obese and have irregular periods. It tests a specific diet against conventional care for 24 weeks.
- Age
- 18 to 49 years
- Sex
- Women only
- Disease stage
- Polycystic ovary syndrome (PCOS) diagnosed by the 2003 Rotterdam criteria (at least 2 of 3 signs), with irregular periods, BMI ≥ 24 kg/m² and waist circumference ≥ 85 cm (33 in).
- Earlier treatment
- Cannot have used in the past 3 months: hormonal contraceptives or implants, anti-androgens, metformin or other insulin-sensitizing drugs, clomiphene, GnRH modulators, minoxidil, weight-loss drugs or oral corticosteroids.
Main reasons for not taking part
- Pregnant, planning pregnancy, breastfeeding, or in or near menopause
- Diabetes, gallstones, gout, or poorly controlled thyroid disease
- Cancer in the past 5 years or now
- Severe liver, kidney or heart and blood vessel disease
- Eating disorder in the past 12 months, or allergy or intolerance to soy, lactose or gluten, or celiac disease
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 49 years old?
Source: NCT07350889, who can take part
Where in China
- Xuanwu Hospital, Capital Medical UniversityBeijing, ChinaContact: Shan Gao, Doctoral degreeNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Xuanwu Hospital, Beijing
- Trial code
- NCT07350889
- Record updated
- 20 January 2026
- Original description
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.Read full original descriptionShow less
Effects of a Specific Dietary Program on Overweight/Obese Women With Polycystic Ovary Syndrome: A Multicenter, Prospective, Randomized Controlled Clinical Study
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.
Inclusion: 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: 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 non-classical 21-hydroxylase deficiency, hyperprolactinemia, Cushing's disease, or adrenal tumors will be excluded from the study; 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 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 with any other medical condition or circumstance that, in the opinion of the investigators, makes them unsuitable for participation will be excluded; 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 who are postmenopausal or perimenopausal, as well as those who are pregnant, planning pregnancy, or currently lactating, will be excluded; Participants who are currently participating in another clinical trial will be excluded.