Diet and Weight Loss Programs for Women with Polycystic Ovary Syndrome
Tests diet plans and weight changes in women with polycystic ovary syndrome.
Plain-language title generated from the registry record
Registry title: Weight Cycling on Hyperandrogenemia and Insulin Resistance in Polycystic Ovary Syndrome
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 18-45 with polycystic ovary syndrome (PCOS) who are of normal weight or overweight/obese, to follow how weight loss on a high-protein diet affects them.
- Age
- 18 to 45 years
- Sex
- Women (all sexes listed, but the criteria say women)
- Disease stage
- Polycystic ovary syndrome diagnosed by the Rotterdam criteria. Normal weight group: BMI 18.5 to under 24 kg/m². Overweight/obese group: BMI 24 kg/m² or more.
- Earlier treatment
- Cannot join if currently using prescription weight loss medicines such as GLP-1RA, orlistat or topiramate, or if they have had weight loss surgery.
Main reasons for not taking part
- Pregnant or breastfeeding, or planning pregnancy within 6 months
- Using prescription weight loss medicines (such as GLP-1RA, orlistat, topiramate)
- History of weight loss surgery
- Severe heart, brain, liver or kidney disease, active cancer, or other severe illness
- Eating disorders or severe anxiety/depression that make the diet hard to follow
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 45 years old?
Source: NCT06545721, who can take part
Where in China
- Peking Union Medical College HospitalBeijing, ChinaContact: Wei Chen, PhDTaking people
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
- Peking Union Medical College Hospital
- Trial code
- NCT06545721
- Record updated
- 3 December 2025
- Original description
This study prospectively includes PCOS patients with normal weight and overweight/obesity, closely follows up and intensively manages them, and observes the level and distribution of weight reduction achieved by patients after lifestyle intervention (high-protein diet for weight loss). Additionally, it aims to provide reference for setting weight loss targets for future PCOS patients by comparing the differences in clinical improvement among patients achieving different degrees of weight reduction (<2% [equivalent to no weight loss], 2-5%, 5-10%, ≥10%) at different time points (3 months, 6 months) following dietary intervention. Furthermore, this study will compare the differences in reproductive and metabolic marker improvements between baseline PCOS patients experiencing weight rebound, those who successfully lost weight, and those who experienced weight rebound. This will help explore the impact of weight cycling on PCOS-related manifestations. Finally, at a genetic level, the study will analyze potential mechanisms underlying different outcome indicators by comparing differences in metagenomics, transcriptomics, and metabolomics among patient groups.Read full original descriptionShow less
The Effect and Mechanism Of Weight Cycling on Hyperandrogenemia And Insulin Resistance in Polycystic Ovary Syndrome
This study prospectively includes PCOS patients with normal weight and overweight/obesity, closely follows up and intensively manages them, and observes the level and distribution of weight reduction achieved by patients after lifestyle intervention (high-protein diet for weight loss). Additionally, it aims to provide reference for setting weight loss targets for future PCOS patients by comparing the differences in clinical improvement among patients achieving different degrees of weight reduction (<2% [equivalent to no weight loss], 2-5%, 5-10%, ≥10%) at different time points (3 months, 6 months) following dietary intervention. Furthermore, this study will compare the differences in reproductive and metabolic marker improvements between baseline PCOS patients experiencing weight rebound, those who successfully lost weight, and those who experienced weight rebound. This will help explore the impact of weight cycling on PCOS-related manifestations. Finally, at a genetic level, the study will analyze potential mechanisms underlying different outcome indicators by comparing differences in metagenomics, transcriptomics, and metabolomics among patient groups.
Ancillary/Nested Sub-study (12-week Precision Nutrition Trial):
Within the WHIP cohort, we will conduct a nested, prospective interventional sub-study to evaluate the efficacy of an insulin-resistance-phenotype-guided precision dietary prescription versus a standard guideline-based energy-restricted diet. Eligible participants are women with PCOS and insulin resistance enrolled in the cohort. The sub-study lasts 12 weeks with assessments at baseline and week 12. Primary endpoints include change in HOMA-IR and change in the core11 metabolic risk composite. Secondary endpoints include changes in gonadotropins (FSH, LH), sex steroid hormones (e.g., estradiol, progesterone), and patient-reported symptom scores.
Inclusion: Women aged 18-45 years in the reproductive period; Women who have previously met the Rotterdam diagnostic criteria (at least 2 of the following 3 criteria have been confirmed, and have been diagnosed with PCOS): 1) Oligomenorrhea and/or anovulation; 2) clinical and/or biochemical evidence of hyperandrogenism; 3) ultrasound showing the presence of unilateral or bilateral polycystic ovaries; Inclusion of 50 women in the normal weight group: 18.5 kg/m² ≤ BMI < 24 kg/m²; Inclusion of 400 women in the overweight/obese group: BMI ≥ 24 kg/m²; Voluntarily participate in the intervention and sign an informed consent form.
Exclusion: Currently using known prescription weight loss medications (such as GLP-1RA, orlistat, topiramate, etc.); History of weight loss surgery; Known history of serious endocrine system diseases; Poor compliance with planned dietary interventions (psychiatric disorders such as binge eating disorder, anorexia nervosa, severe anxiety/depression); History of severe cardiovascular or cerebrovascular diseases; severe liver or kidney dysfunction (ALT > 3 times the upper limit of normal, or creatinine > 1.5 times the upper limit of normal); chronic or active gastrointestinal inflammatory diseases; severe systemic diseases; active malignant tumors; Currently pregnant or lactating, or have had a recent (within 6 months) plan for pregnancy; Secondary obesity: including hypothalamic or pituitary obesity, obesity secondary to glucocorticoid use, hypogonadism-induced obesity, etc; Unable to follow up on time or deemed non-cooperative by the investigator.