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

NCT07350889 | Not Yet Recruiting DMC

• 1 other identifier: [2025]438-002
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Does the specific dietary program increase the clinical remission rate of PCOS in overweight or obese patients?
2. 2.Does the specific dietary program improve metabolic and anthropometric outcomes in overweight or obese patients with PCOS compared with conventional intervention?
3. 3.Receive either a specific dietary intervention or conventional intervention for 24 weeks.
4. 4.Undergo assessments every 12 weeks throughout the study period.

Conditions

Polycystic Ovary Syndrome (PCOS)

Outcome Measures

Primary Outcomes (1)

• Clinical remission rate of PCOS

  he proportion of participants who achieved regular menstrual cycles after 24 weeks of intervention and maintained regular cycles for at least 3 consecutive months.

  Baseline and Week 24

Secondary Outcomes (18)

• Waist circumference

  Baseline, Week 12, and Week 24

• Blood pressure

  Baseline, Week 12, and Week 24

• Weight

  Baseline, Week 12, and Week 24

• Body fat percentage

  Baseline, Week 12, and Week 24

• Skeletal muscle mass

  Baseline, Week 12, and Week 24

Study Arms (2)

Specific dietary intervention

EXPERIMENTAL

Behavioral: Specific dietary intervention group

Conventional intervention

ACTIVE COMPARATOR

Behavioral: Conventional intervention

Interventions

Specific dietary intervention group BEHAVIORAL

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 consists of 1000 kcal for lunch and dinner daily, with a focus on high protein (\>80g) and high fiber (\>30g) to support weight management and improve metabolic status. This intervention will continue for 24 weeks. 3. Food Ingredients and Intervention Frequency The intervention uses natural ingredients, with at least 12 types of foods daily. Participants will have 5 days of standardized meals and 2 free eating days per week to improve adherence. The intervention will last for 24 weeks.

Specific dietary intervention

Conventional intervention BEHAVIORAL

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.

Conventional intervention

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead
• Jinan Central Hospital: collaborator
• Civil Aviation General Hospital: collaborator
• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: collaborator

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, China

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

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

Study Officials

• Shan Gao, Doctoral degree

  Xuanwu Hospital, Beijing

  STUDY CHAIR

Central Study Contacts

Ziye Gong

CONTACT

86+13699126297; gongziye202211@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2025
• First Posted: January 20, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 20, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)