Polycystic Ovary Syndrome (PCOS)NCT07350889
Effects of a Specific Dietary Program on Overweight/Obese Women With Polycystic Ovary Syndrome: A Multicenter, Prospective, Randomized Controlled Clinical Study
A study testing Specific dietary intervention group and Conventional intervention in people with Polycystic Ovary Syndrome (PCOS), run by Xuanwu Hospital, Beijing at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome (PCOS)
- What is being tested?
- Specific dietary intervention group and Conventional intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2026to 31 Dec 2027
- 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 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 substance abuse, acute infectious diseases, or diabetes mellitus will not be eligible for inclusion.
- 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.
Show all 14Show fewer
- 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.
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
Xuanwu Hospital, Capital Medical University
Beijing
Shan Gao, Doctoral degree, 86+13910599635, gaoshanmw@163.com
About this study
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:
Read more
- Does the specific dietary program increase the clinical remission rate of PCOS in overweight or obese patients?
- 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:
- Receive either a specific dietary intervention or conventional intervention for 24 weeks.
- Undergo assessments every 12 weeks throughout the study period.
- Conditions
- Polycystic Ovary Syndrome (PCOS)
- Being tested
- Specific dietary intervention group, Conventional intervention
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specific dietary intervention groupBehavioural
- 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.
- 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.
- 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.
Conventional interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Specific dietary intervention | Experimental | Not described Receives: Behavioral: Specific dietary intervention group |
| Conventional intervention | Active comparator | Not described Receives: Behavioral: Conventional intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Week 24
Secondary outcomes (18)
Waist circumference
Measured: Baseline, Week 12, and Week 24
Blood pressure
Measured: Baseline, Week 12, and Week 24
Weight
Measured: Baseline, Week 12, and Week 24
Body fat percentage
Measured: Baseline, Week 12, and Week 24
Skeletal muscle mass
Measured: Baseline, Week 12, and Week 24
Basal metabolic rate
Measured: 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.
Measured: Baseline and Week 24
Progesterone
Measured: Baseline and Week 24
Fasting plasma glucose
Measured: Baseline and Week 24
Fasting insulin
Measured: Baseline and Week 24
Total cholesterol
Measured: Baseline and Week 24
Low-density lipoprotein cholesterol
Measured: Baseline and Week 24
High-density lipoprotein cholesterol
Measured: Baseline and Week 24
Triglycerides
Measured: Baseline and Week 24
Aspartate aminotransferase
Measured: Baseline and Week 24
Alanine aminotransferase
Measured: 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.
Measured: 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.
Measured: Baseline, Week 12, and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start15 Jan 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary Syndrome (PCOS)Studies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- Jinan Central Hospital, Civil Aviation General Hospital, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Responsible party
- Sponsor
- Investigators
- Shan Gao, Doctoral degree, Study chair, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07350889
- Sponsor's protocol ID
- [2025]438-002
- Status last verified
- Dec 2025
- First submitted
- 30 Dec 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to privacy concerns and the need to protect sensitive participant information. Sharing the data could potentially breach confidentiality agreements and ethical guidelines, as the de-identified data might still be traceable back to participants. Additionally, the research team has not obtained prior consent for data sharing, and sharing IPD would require additional approvals from the ethics committee and participants.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Specific Dietary Program on Overweight/Obese Women With Polycystic Ovary Syndrome: A Multicenter, Prospective, Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT07350889
- Acronym / sponsor ID
- [2025]438-002
- Conditions
- Polycystic Ovary Syndrome (PCOS)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Collaborators
- Jinan Central Hospital, Civil Aviation General Hospital, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Study start
- 15 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Jan 2026 (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.
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:
- Does the specific dietary program increase the clinical remission rate of PCOS in overweight or obese patients?
- 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:
- Receive either a specific dietary intervention or conventional intervention for 24 weeks.
- Undergo assessments every 12 weeks throughout the study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Specific dietary intervention | Experimental | Behavioral: Specific dietary intervention group |
| Conventional intervention | Active comparator | Behavioral: Conventional intervention |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (14 listed)
- 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 substance abuse, acute infectious diseases, or diabetes mellitus will not be eligible for inclusion.
- 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.
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 |
|---|---|---|
| Specific dietary intervention group1. 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. | Behavioural | Specific dietary intervention |
| Conventional interventionThe 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. | Behavioural | Conventional intervention |
Primary outcome
Clinical remission rate of PCOS
Time frame: Baseline and Week 24
he proportion of participants who achieved regular menstrual cycles after 24 weeks of intervention and maintained regular cycles for at least 3 consecutive months.
18 secondary outcomes
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
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)
Time frame: Baseline, Week 12, and Week 24
Psychological status assessed by standardized questionnaire
Time frame: Baseline, Week 12, and Week 24
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 20 Jan 2026.
- Individual participant dataSharing planned: No. IPD will not be shared due to privacy concerns and the need to protect sensitive participant information. Sharing the data could potentially breach confidentiality agreements and ethical guidelines, as the de-identified data might still be traceable back to participants. Additionally, the research team has not obtained prior consent for data sharing, and sharing IPD would require additional approvals from the ethics committee and participants.
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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.
Shan Gao, Doctoral degree study chair
Xuanwu Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Specific dietary intervention group and Conventional intervention in people with Polycystic Ovary Syndrome (PCOS), run by Xuanwu Hospital, Beijing 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 6 inclusion and 14 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: opening soon, as of the sponsor's last update on 20 Jan 2026. 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 Ziye Gong (86+13699126297, gongziye202211@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical remission rate of PCOS (time frame: Baseline and Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.