Polycystic Ovary SyndromeWHIPNCT06545721
Weight Cycling on Hyperandrogenemia and Insulin Resistance in Polycystic Ovary Syndrome
A study testing Adjusting dietary structure + exercise + behavioral intervention, Precision dietary prescription and Standard guideline-based low-energy diet in people with Polycystic Ovary Syndrome, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Adjusting dietary structure + exercise + behavioral intervention, Precision dietary prescription and Standard guideline-based low-energy diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 425 participants
- Where
- 1 siteChina
- Study dates
- 13 Aug 2024to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Currently pregnant or lactating, or have had a recent (within 6 months) plan for pregnancy;
- Currently using known prescription weight loss medications (such as GLP-1RA, orlistat, topiramate, etc.);
- History of weight loss surgery;
- 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;
- Secondary obesity: including hypothalamic or pituitary obesity, obesity secondary to glucocorticoid use, hypogonadism-induced obesity, etc.;
- 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);
- Unable to follow up on time or deemed non-cooperative by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Wei Chen, PhD, 13911006820, txchenwei@sina.com
Menglu Zhang, PhD, 13051336015, 499527281@qq.com
About this study
Official title: 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.
Read the detailed description
This study is a single-center, prospective cohort study that enrolled PCOS patients after screening. The patients were categorized into two groups based on their BMI: a normal weight group (18.5 kg/m2 ≤ BMI < 24 kg/m2) with a sample size of 45 and an overweight/obese group (BMI ≥ 24 kg/m2) with a sample size of 380, totaling 425 cases.
For the normal weight PCOS patients, interventions included control of total energy intake, adjustment of dietary structure, exercise, and behavioral intervention to prevent weight gain over a follow-up period of three months. If weight gain occurred during the follow-up period, these patients were transferred to the overweight/obese group for intensified intervention.
The overweight/obese PCOS patients received intensive intervention in accordance with high-protein diet adaptation criteria. This involved high-protein diets combined with exercise and behavioral intervention for weight reduction. After three months of follow-up, if they achieved their weight-loss goal, they transitioned to a low-energy diet and exercise intervention program to maintain their weight. If the goal was not met after three months, they continued with the high-protein weight-loss program.
The study compared differences in improvement in indicators such as insulin resistance (IR), blood androgen levels, inflammatory factors among different degrees of weight loss (<2%, 2% ≤weight loss <5%, 5%≤weight loss<10%, ≥10%), analyzing potential mechanisms.
For individuals experiencing weight cycling, differences in IR levels before and after rebounding from body mass were compared alongside changes in androgen levels and other metabolic indicators. This aimed to explore the impact of body mass cycling on clinical indicators while analyzing potential causes.
Ancillary/Nested Sub-study (12-week Precision Nutrition Trial):
A subset of cohort participants meeting criteria for PCOS with insulin resistance will enter a 12-week dietary intervention sub-study. Participants will be allocated in a 1:1 ratio to: (1) a phenotype-guided precision dietary prescription tailored to the individual's insulin-resistance metabolic subtype; or (2) a standard low-energy diet based on current Chinese clinical guidelines for overweight/obesity medical nutrition therapy. Both groups receive standardized lifestyle counseling and follow-up. Study visits occur at baseline and week 12. This nested sub-study is designed to test whether subtype-matched dietary prescriptions yield greater improvements in insulin resistance and metabolic risk than a uniform guideline diet, while remaining integrated within the parent WHIP cohort.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Adjusting dietary structure + exercise + behavioral intervention, Precision dietary prescription, Standard guideline-based low-energy diet
- Keywords
- Weight Cycling, Hyperandrogenemia, Insulin Resistance, High-protein diet, Transcriptome, Metabolome, Inflammatory status
- Medical subject headings
- Polycystic Ovary Syndrome, Weight Cycling, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjusting dietary structure + exercise + behavioral interventionOther
Adjusting to a healthy diet involves consuming low GI and low-fat foods, avoiding sugary drinks, increasing dietary fiber intake, reducing saturated fat while increasing omega-3 unsaturated fat intake, and limiting trans fat consumption. A weight loss program includes a high-protein diet, exercise, and behavioral intervention with daily total energy needs calculated based on ideal body weight (kg) x 15-20 kcal/kg/d; developing a daily meal plan with regular protein supplementation; limiting salt intake to ≤5 g/d; ensuring adequate water consumption at 2-3L/d; aiming for a dietary fiber intake of 25-30g/d; recommending micronutrient supplementation as needed; maintaining daily aerobic exercise (40 minutes at 70-80% HRmax) along with resistance training (20 minutes); establishing an early bedtime before 11pm and an early wake-up time.
Precision dietary prescriptionBehavioural
A 12-week precision diet program individualized to baseline insulin-resistance metabolic subphenotype, including personalized macronutrient targets, food-based meal plans, and dietitian-led counseling with regular follow-ups.
Standard guideline-based low-energy dietBehavioural
A 12-week standardized low-energy diet based on national guideline recommendations for overweight/obesity, with the same counseling frequency as the precision-diet arm but without metabolic tailoring.
| Study group | Role | What they receive |
|---|---|---|
| Normal weight group | Experimental | 18.5 kg/m2 ≤ BMI < 24 kg/m2 Receives: Other: Adjusting dietary structure + exercise + behavioral intervention |
| Obese/Overweight Group | Experimental | BMI ≥24 kg/m² Receives: Other: Adjusting dietary structure + exercise + behavioral intervention |
| Precision dietary prescription (nested substudy) | Experimental | Within the WHIP cohort, participants with PCOS and insulin resistance who enroll in the ancillary 12-week pragmatic intervention will receive a precision dietary prescription tailored to their baseline insulin-resistance metabolic subphenotype. The prescription includes an individualized daily energy deficit according to the Chinese guideline for medical nutrition therapy in overweight/obesity, personalized macronutrient distribution, and food-based meal plans. Participants receive dietitian counseling at baseline and scheduled follow-ups throughout the 12-week period, in addition to standard lifestyle advice provided in the parent cohort. Receives: Behavioral: Precision dietary prescription |
| Standard guideline-based low-energy diet (nested substudy control) | Active comparator | Within the WHIP cohort, participants with PCOS and insulin resistance who enroll in the ancillary 12-week pragmatic intervention will receive a uniform low-energy diet based on standard guideline recommendations. The daily energy deficit is set according to the Chinese guideline for medical nutrition therapy in overweight/obesity, without tailoring to metabolic subphenotype. Contact frequency and follow-up intensity are comparable to the precision-diet arm, and standard lifestyle advice is provided throughout the 12-week period. Receives: Behavioral: Standard guideline-based low-energy diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss rate
Percentage of weight loss: (Weight after reduction - Baseline weight before reduction) / Baseline weight before reduction (%)
Measured: 6 month
Levels of insulin resistance
Measuring the level of insulin resistance in patients after the intervention.
Measured: 6 month
Secondary outcomes (10)
Fasting insulin level（FINS）
Measure the fasting insulin levels of patients after the intervention.
Measured: 6 month
Fasting blood sugar（FBG）
Measure the fasting blood glucose level of the patient after the intervention.
Measured: 6 month
Blood levels of androgen hormones (total testosterone, free testosterone index)
Measure the blood testosterone levels of the patients after the intervention.
Measured: 6 month
Blood lipid levels (LDL-C, HDL-C, total cholesterol)
Measure lipid levels in patients after the intervention.
Measured: 6 month
Levels of inflammatory factors (CRP, IL-6, TAC, GSH)
Detect the level of inflammatory factors in patients after intervention.
Measured: 6 month
BMI
Measuring the BMI of patients after the intervention.
Measured: 6 month
Waist
Measure the waist of the patients after the intervention.
Measured: 6 month
waist-to-hip ratio
Measure the waist-to-hip ratio of the patients after the intervention.
Measured: 6 month
Body fat percentage and distribution
Measure the Body Fat Content and Proportion in Patients after Intervention
Measured: 6 month
Weight rebound rate
Determine the rate of weight rebound in patients after intervention. Weight rebound is defined as a rebound in weight (≥5kg or 5% above baseline weight) after weight loss.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start13 Aug 2024
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- the sample size for the normal weight group is 45, and the sample size for the overweight/obese group is 380.
- Masking
- None (open label)
- Enrolment
- 425 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Chen, Peking Union Medical College Hospital
- Investigators
- Wei Chen, PhD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06545721
- Sponsor's protocol ID
- K5204
- Acronym
- WHIP
- Status last verified
- Nov 2025
- First submitted
- 22 Jul 2024
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lizneva D, Suturina L, Walker W, Brakta S, Gavrilova-Jordan L, Azziz R. Criteria, prevalence, and phenotypes of polycystic ovary syndrome. Fertil Steril. 2016 Jul;106(1):6-15. doi: 10.1016/j.fertnstert.2016.05.003. Epub 2016 May 24.
PubMed 27233760Rotterdam ESHRE/ASRM-Sponsored PCOS consensus workshop group. Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome (PCOS). Hum Reprod. 2004 Jan;19(1):41-7. doi: 10.1093/humrep/deh098.
PubMed 14688154Moran LJ, Misso ML, Wild RA, Norman RJ. Impaired glucose tolerance, type 2 diabetes and metabolic syndrome in polycystic ovary syndrome: a systematic review and meta-analysis. Hum Reprod Update. 2010 Jul-Aug;16(4):347-63. doi: 10.1093/humupd/dmq001. Epub 2010 Feb 16.
PubMed 20159883Barry JA, Kuczmierczyk AR, Hardiman PJ. Anxiety and depression in polycystic ovary syndrome: a systematic review and meta-analysis. Hum Reprod. 2011 Sep;26(9):2442-51. doi: 10.1093/humrep/der197. Epub 2011 Jul 1.
PubMed 21725075Teede HJ, Misso ML, Costello MF, Dokras A, Laven J, Moran L, Piltonen T, Norman RJ; International PCOS Network. Recommendations from the international evidence-based guideline for the assessment and management of polycystic ovary syndrome. Hum Reprod. 2018 Sep 1;33(9):1602-1618. doi: 10.1093/humrep/dey256.
PubMed 30052961Azziz R, Carmina E, Chen Z, Dunaif A, Laven JS, Legro RS, Lizneva D, Natterson-Horowtiz B, Teede HJ, Yildiz BO. Polycystic ovary syndrome. Nat Rev Dis Primers. 2016 Aug 11;2:16057. doi: 10.1038/nrdp.2016.57.
PubMed 27510637Randeva HS, Tan BK, Weickert MO, Lois K, Nestler JE, Sattar N, Lehnert H. Cardiometabolic aspects of the polycystic ovary syndrome. Endocr Rev. 2012 Oct;33(5):812-41. doi: 10.1210/er.2012-1003. Epub 2012 Jul 24.
PubMed 22829562Cowan S, Lim S, Alycia C, Pirotta S, Thomson R, Gibson-Helm M, Blackmore R, Naderpoor N, Bennett C, Ee C, Rao V, Mousa A, Alesi S, Moran L. Lifestyle management in polycystic ovary syndrome - beyond diet and physical activity. BMC Endocr Disord. 2023 Jan 16;23(1):14. doi: 10.1186/s12902-022-01208-y.
PubMed 36647089Stepto NK, Cassar S, Joham AE, Hutchison SK, Harrison CL, Goldstein RF, Teede HJ. Women with polycystic ovary syndrome have intrinsic insulin resistance on euglycaemic-hyperinsulaemic clamp. Hum Reprod. 2013 Mar;28(3):777-84. doi: 10.1093/humrep/des463. Epub 2013 Jan 12.
PubMed 23315061Teede HJ, Joham AE, Paul E, Moran LJ, Loxton D, Jolley D, Lombard C. Longitudinal weight gain in women identified with polycystic ovary syndrome: results of an observational study in young women. Obesity (Silver Spring). 2013 Aug;21(8):1526-32. doi: 10.1002/oby.20213. Epub 2013 Jul 2.
PubMed 23818329Lim SS, Davies MJ, Norman RJ, Moran LJ. Overweight, obesity and central obesity in women with polycystic ovary syndrome: a systematic review and meta-analysis. Hum Reprod Update. 2012 Nov-Dec;18(6):618-37. doi: 10.1093/humupd/dms030. Epub 2012 Jul 4.
PubMed 22767467Kazemi M, Hadi A, Pierson RA, Lujan ME, Zello GA, Chilibeck PD. Effects of Dietary Glycemic Index and Glycemic Load on Cardiometabolic and Reproductive Profiles in Women with Polycystic Ovary Syndrome: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Adv Nutr. 2021 Feb 1;12(1):161-178. doi: 10.1093/advances/nmaa092.
PubMed 32805007Lim SS, Hutchison SK, Van Ryswyk E, Norman RJ, Teede HJ, Moran LJ. Lifestyle changes in women with polycystic ovary syndrome. Cochrane Database Syst Rev. 2019 Mar 28;3(3):CD007506. doi: 10.1002/14651858.CD007506.pub4.
PubMed 30921477Goss AM, Chandler-Laney PC, Ovalle F, Goree LL, Azziz R, Desmond RA, Wright Bates G, Gower BA. Effects of a eucaloric reduced-carbohydrate diet on body composition and fat distribution in women with PCOS. Metabolism. 2014 Oct;63(10):1257-64. doi: 10.1016/j.metabol.2014.07.007. Epub 2014 Jul 18.
PubMed 25125349Gokee-LaRose J, Gorin AA, Raynor HA, Laska MN, Jeffery RW, Levy RL, Wing RR. Are standard behavioral weight loss programs effective for young adults? Int J Obes (Lond). 2009 Dec;33(12):1374-80. doi: 10.1038/ijo.2009.185.
PubMed 19786967
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect and Mechanism Of Weight Cycling on Hyperandrogenemia And Insulin Resistance in Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT06545721
- Acronym / sponsor ID
- WHIP / K5204
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- Weight Cycling, Hyperandrogenemia, Insulin Resistance, High-protein diet, Transcriptome, Metabolome, Inflammatory status
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 425 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 13 Aug 2024 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a single-center, prospective cohort study that enrolled PCOS patients after screening. The patients were categorized into two groups based on their BMI: a normal weight group (18.5 kg/m2 ≤ BMI < 24 kg/m2) with a sample size of 45 and an overweight/obese group (BMI ≥ 24 kg/m2) with a sample size of 380, totaling 425 cases.
For the normal weight PCOS patients, interventions included control of total energy intake, adjustment of dietary structure, exercise, and behavioral intervention to prevent weight gain over a follow-up period of three months. If weight gain occurred during the follow-up period, these patients were transferred to the overweight/obese group for intensified intervention.
The overweight/obese PCOS patients received intensive intervention in accordance with high-protein diet adaptation criteria. This involved high-protein diets combined with exercise and behavioral intervention for weight reduction. After three months of follow-up, if they achieved their weight-loss goal, they transitioned to a low-energy diet and exercise intervention program to maintain their weight. If the goal was not met after three months, they continued with the high-protein weight-loss program.
The study compared differences in improvement in indicators such as insulin resistance (IR), blood androgen levels, inflammatory factors among different degrees of weight loss (<2%, 2% ≤weight loss <5%, 5%≤weight loss<10%, ≥10%), analyzing potential mechanisms.
For individuals experiencing weight cycling, differences in IR levels before and after rebounding from body mass were compared alongside changes in androgen levels and other metabolic indicators. This aimed to explore the impact of body mass cycling on clinical indicators while analyzing potential causes.
Ancillary/Nested Sub-study (12-week Precision Nutrition Trial):
A subset of cohort participants meeting criteria for PCOS with insulin resistance will enter a 12-week dietary intervention sub-study. Participants will be allocated in a 1:1 ratio to: (1) a phenotype-guided precision dietary prescription tailored to the individual's insulin-resistance metabolic subtype; or (2) a standard low-energy diet based on current Chinese clinical guidelines for overweight/obesity medical nutrition therapy. Both groups receive standardized lifestyle counseling and follow-up. Study visits occur at baseline and week 12. This nested sub-study is designed to test whether subtype-matched dietary prescriptions yield greater improvements in insulin resistance and metabolic risk than a uniform guideline diet, while remaining integrated within the parent WHIP cohort.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- the sample size for the normal weight group is 45, and the sample size for the overweight/obese group is 380.
| Arm | Type | Receives |
|---|---|---|
| Normal weight group | Experimental | Other: Adjusting dietary structure + exercise + behavioral intervention18.5 kg/m2 ≤ BMI < 24 kg/m2 |
| Obese/Overweight Group | Experimental | Other: Adjusting dietary structure + exercise + behavioral interventionBMI ≥24 kg/m² |
| Precision dietary prescription (nested substudy) | Experimental | Behavioral: Precision dietary prescriptionWithin the WHIP cohort, participants with PCOS and insulin resistance who enroll in the ancillary 12-week pragmatic intervention will receive a precision dietary prescription tailored to their baseline insulin-resistance metabolic subphenotype. The prescription includes an individualized daily energy deficit according to the Chinese guideline for medical nutrition therapy in overweight/obesity, personalized macronutrient distribution, and food-based meal plans. Participants receive dietitian counseling at baseline and scheduled follow-ups throughout the 12-week period, in addition to standard lifestyle advice provided in the parent cohort. |
| Standard guideline-based low-energy diet (nested substudy control) | Active comparator | Behavioral: Standard guideline-based low-energy dietWithin the WHIP cohort, participants with PCOS and insulin resistance who enroll in the ancillary 12-week pragmatic intervention will receive a uniform low-energy diet based on standard guideline recommendations. The daily energy deficit is set according to the Chinese guideline for medical nutrition therapy in overweight/obesity, without tailoring to metabolic subphenotype. Contact frequency and follow-up intensity are comparable to the precision-diet arm, and standard lifestyle advice is provided throughout the 12-week period. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- Currently pregnant or lactating, or have had a recent (within 6 months) plan for pregnancy;
- Currently using known prescription weight loss medications (such as GLP-1RA, orlistat, topiramate, etc.);
- History of weight loss surgery;
- 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;
- Secondary obesity: including hypothalamic or pituitary obesity, obesity secondary to glucocorticoid use, hypogonadism-induced obesity, etc.;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adjusting dietary structure + exercise + behavioral interventionAdjusting to a healthy diet involves consuming low GI and low-fat foods, avoiding sugary drinks, increasing dietary fiber intake, reducing saturated fat while increasing omega-3 unsaturated fat intake, and limiting trans fat consumption. A weight loss program includes a high-protein diet, exercise, and behavioral intervention with daily total energy needs calculated based on ideal body weight (kg) x 15-20 kcal/kg/d; developing a daily meal plan with regular protein supplementation; limiting salt intake to ≤5 g/d; ensuring adequate water consumption at 2-3L/d; aiming for a dietary fiber intake of 25-30g/d; recommending micronutrient supplementation as needed; maintaining daily aerobic exercise (40 minutes at 70-80% HRmax) along with resistance training (20 minutes); establishing an early bedtime before 11pm and an early wake-up time. | Other | Normal weight group, Obese/Overweight Group |
| Precision dietary prescriptionA 12-week precision diet program individualized to baseline insulin-resistance metabolic subphenotype, including personalized macronutrient targets, food-based meal plans, and dietitian-led counseling with regular follow-ups. | Behavioural | Precision dietary prescription (nested substudy) |
| Standard guideline-based low-energy dietA 12-week standardized low-energy diet based on national guideline recommendations for overweight/obesity, with the same counseling frequency as the precision-diet arm but without metabolic tailoring. | Behavioural | Standard guideline-based low-energy diet (nested substudy control) |
Primary outcome
Weight loss rate
Time frame: 6 month
Percentage of weight loss: (Weight after reduction - Baseline weight before reduction) / Baseline weight before reduction (%)
Levels of insulin resistance
Time frame: 6 month
Measuring the level of insulin resistance in patients after the intervention.
10 secondary outcomes
Fasting insulin level（FINS）
Time frame: 6 month
Fasting blood sugar（FBG）
Time frame: 6 month
Blood levels of androgen hormones (total testosterone, free testosterone index)
Time frame: 6 month
Blood lipid levels (LDL-C, HDL-C, total cholesterol)
Time frame: 6 month
Levels of inflammatory factors (CRP, IL-6, TAC, GSH)
Time frame: 6 month
BMI
Time frame: 6 month
Waist
Time frame: 6 month
waist-to-hip ratio
Time frame: 6 month
Body fat percentage and distribution
Time frame: 6 month
Weight rebound rate
Time frame: 6 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Background: PubMed 27233760Lizneva D, Suturina L, Walker W, Brakta S, Gavrilova-Jordan L, Azziz R. Criteria, prevalence, and phenotypes of polycystic ovary syndrome. Fertil Steril. 2016 Jul;106(1):6-15. doi: 10.1016/j.fertnstert.2016.05.003. Epub 2016 May 24.
- Background: PubMed 14688154Rotterdam ESHRE/ASRM-Sponsored PCOS consensus workshop group. Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome (PCOS). Hum Reprod. 2004 Jan;19(1):41-7. doi: 10.1093/humrep/deh098.
- Background: PubMed 20159883Moran LJ, Misso ML, Wild RA, Norman RJ. Impaired glucose tolerance, type 2 diabetes and metabolic syndrome in polycystic ovary syndrome: a systematic review and meta-analysis. Hum Reprod Update. 2010 Jul-Aug;16(4):347-63. doi: 10.1093/humupd/dmq001. Epub 2010 Feb 16.
- Background: PubMed 21725075Barry JA, Kuczmierczyk AR, Hardiman PJ. Anxiety and depression in polycystic ovary syndrome: a systematic review and meta-analysis. Hum Reprod. 2011 Sep;26(9):2442-51. doi: 10.1093/humrep/der197. Epub 2011 Jul 1.
- Background: PubMed 30052961Teede HJ, Misso ML, Costello MF, Dokras A, Laven J, Moran L, Piltonen T, Norman RJ; International PCOS Network. Recommendations from the international evidence-based guideline for the assessment and management of polycystic ovary syndrome. Hum Reprod. 2018 Sep 1;33(9):1602-1618. doi: 10.1093/humrep/dey256.
- Background: PubMed 27510637Azziz R, Carmina E, Chen Z, Dunaif A, Laven JS, Legro RS, Lizneva D, Natterson-Horowtiz B, Teede HJ, Yildiz BO. Polycystic ovary syndrome. Nat Rev Dis Primers. 2016 Aug 11;2:16057. doi: 10.1038/nrdp.2016.57.
- Background: PubMed 22829562Randeva HS, Tan BK, Weickert MO, Lois K, Nestler JE, Sattar N, Lehnert H. Cardiometabolic aspects of the polycystic ovary syndrome. Endocr Rev. 2012 Oct;33(5):812-41. doi: 10.1210/er.2012-1003. Epub 2012 Jul 24.
- Background: PubMed 36647089Cowan S, Lim S, Alycia C, Pirotta S, Thomson R, Gibson-Helm M, Blackmore R, Naderpoor N, Bennett C, Ee C, Rao V, Mousa A, Alesi S, Moran L. Lifestyle management in polycystic ovary syndrome - beyond diet and physical activity. BMC Endocr Disord. 2023 Jan 16;23(1):14. doi: 10.1186/s12902-022-01208-y.
- Background: PubMed 23315061Stepto NK, Cassar S, Joham AE, Hutchison SK, Harrison CL, Goldstein RF, Teede HJ. Women with polycystic ovary syndrome have intrinsic insulin resistance on euglycaemic-hyperinsulaemic clamp. Hum Reprod. 2013 Mar;28(3):777-84. doi: 10.1093/humrep/des463. Epub 2013 Jan 12.
- Background: PubMed 23818329Teede HJ, Joham AE, Paul E, Moran LJ, Loxton D, Jolley D, Lombard C. Longitudinal weight gain in women identified with polycystic ovary syndrome: results of an observational study in young women. Obesity (Silver Spring). 2013 Aug;21(8):1526-32. doi: 10.1002/oby.20213. Epub 2013 Jul 2.
- Background: PubMed 22767467Lim SS, Davies MJ, Norman RJ, Moran LJ. Overweight, obesity and central obesity in women with polycystic ovary syndrome: a systematic review and meta-analysis. Hum Reprod Update. 2012 Nov-Dec;18(6):618-37. doi: 10.1093/humupd/dms030. Epub 2012 Jul 4.
- Background: PubMed 32805007Kazemi M, Hadi A, Pierson RA, Lujan ME, Zello GA, Chilibeck PD. Effects of Dietary Glycemic Index and Glycemic Load on Cardiometabolic and Reproductive Profiles in Women with Polycystic Ovary Syndrome: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Adv Nutr. 2021 Feb 1;12(1):161-178. doi: 10.1093/advances/nmaa092.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wei Chen, PhD principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adjusting dietary structure + exercise + behavioral intervention, Precision dietary prescription and Standard guideline-based low-energy diet in people with Polycystic Ovary Syndrome, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei Chen, PhD (13911006820, txchenwei@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss rate (time frame: 6 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06545721, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.