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Dietary program aims to tame PCOS in overweight women

NCT ID NCT07350889

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a 24-week dietary program for overweight or obese women with polycystic ovary syndrome (PCOS). The goal is to see if a carefully planned, calorie-controlled diet can improve menstrual regularity and metabolic health better than standard care. 160 women will participate across multiple centers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
specific dietary program (calorie-controlled meal plans)
What this could lead to
If it works, this could point toward a non-drug dietary approach to help manage PCOS symptoms and improve menstrual regularity.
What could go wrong
This is an early-stage trial with no results yet. The dietary program may be hard to follow long-term, and benefits may not be better than standard advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 160 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 49 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Female participants aged 18-49 years. 2. Body mass index (BMI) ≥ 24 kg/m² and waist circumference ≥ 85 cm. 3. 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. 4. Menstrual irregularity. 5. Use of reliable non-hormonal contraception throughout the study period. 6. Provision of written informed consent. Exclusion Criteria: 1. Participants with non-classical 21-hydroxylase deficiency, hyperprolactinemia, Cushing's disease, or adrenal tumors will be excluded from the study. 2. Participants who are postmenopausal or perimenopausal, as well as those who are pregnant, planning pregnancy, or currently lactating, will be excluded. 3. Participants with a history of substance abuse, acute infectious diseases, or diabetes mellitus will not be eligible for inclusion. 4. Participants with a history of malignancy within the past 5 years or with current malignant disease will be excluded. 5. Participants with a history of gallstones or gout will be excluded from the study. 6. Participants with poorly controlled thyroid disorders, regardless of etiology, will be excluded. 7. Participants who have been diagnosed with an eating disorder within the past 12 months will be excluded. 8. 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. 9. 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. 10. Participants with severe hepatic impairment, defined as alanine aminotransferase (ALT) \> 100 U/L or aspartate aminotransferase (AST) \> 100 U/L, will be excluded. 11. Participants with severe renal impairment, defined as an estimated glomerular filtration rate (eGFR) \< 80 mL/min, will be excluded. 12. 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. 13. Participants who are currently participating in another clinical trial will be excluded. 14. Participants with any other medical condition or circumstance that, in the opinion of the investigators, makes them unsuitable for participation will be excluded.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Xuanwu Hospital, Capital Medical University

    Beijing, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.