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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
160
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.
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.
Xuanwu Hospital, Capital Medical University
Beijing, China
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.
Time frame: Baseline and Week 24
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
Serum AMH levels will be measured in fasting serum samples collected at predefined study time points. Outcomes will be reported as circulating AMH concentrations and will be used to assess changes in ovarian reserve-related endocrine function between baseline and post-intervention time points and/or between intervention groups.
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
High-density lipoprotein cholesterol
Time frame: Baseline and Week 24
Triglycerides
Time frame: Baseline and Week 24
Aspartate aminotransferase
Time frame: Baseline and Week 24
Alanine aminotransferase
Time frame: Baseline and Week 24
Dietary intake assessed by food frequency questionnaire (FFQ)
Dietary intake will be assessed using a validated FFQ at predefined study time points. Outcomes will include quantitative estimates of habitual dietary intake, including energy and nutrient intakes, and comparisons of changes in dietary intake between study time points and/or between intervention groups.
Time frame: Baseline, Week 12, and Week 24
Psychological status assessed by standardized questionnaire
Psychological status will be assessed using a standardized, validated questionnaire administered at predefined study time points. Outcome measures will include questionnaire scores summarized as continuous variables, and changes in psychological status will be compared between baseline and post-intervention time points and/or between intervention groups.
Time frame: Baseline, Week 12, and Week 24
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