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

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. 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.

Conditions

• Polycystic Ovary Syndrome (PCOS)

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 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.

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.

Sponsors & Collaborators

• Jinan Central Hospital

  collaborator OTHER

• Civil Aviation General Hospital

  collaborator OTHER

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences

  collaborator OTHER

• Xuanwu Hospital, Beijing

  lead OTHER

Principal Investigators

• Shan Gao, Doctoral degree · Xuanwu Hospital, Beijing

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

49 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-15

Primary Completion

2027-12-31

Completion

2027-12-31

Countries

• China

Study Locations