Can a diet app tame PCOS symptoms? new study investigates

NCT ID NCT07598344

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Recruiting now
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Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
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Paused for now. It may or may not start again.
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Running, but no longer taking on new participants.
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The trial has finished. Results may not be published yet.
Stopped early
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Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
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First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study will test if a mobile app that gives personalized Mediterranean diet advice can help women with PCOS improve their cholesterol, weight, and overall health. Sixty women will be split into two groups: one using the app and one getting standard lifestyle advice. The goal is to see if the app makes it easier to manage PCOS symptoms and improve quality of life over 6 months.

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 60 people

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

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Jun 2029

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 45 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: * Female participants aged 18 to 45 years. * Diagnosis of polycystic ovary syndrome (PCOS) with an anovulatory phenotype according to the Rotterdam criteria (2003). * Oligo-ovulation or anovulation, defined as menstrual cycle length greater than 35 days or fewer than 8 menstrual periods per year, together with at least one of the following: * Clinical and/or biochemical hyperandrogenism. * Polycystic ovarian morphology on ultrasound, defined as at least 20 follicles measuring 2 to 9 mm in either ovary and/or ovarian volume of at least 10 cm3. * Possession of a smartphone compatible with the study application (Android or iOS). * Ability and willingness to use the mobile application and comply with study procedures. * Provision of written informed consent before any study-specific procedures are performed. Exclusion Criteria: * Pregnancy or breastfeeding at the time of enrollment. * Planning pregnancy during the study period. * Type 1 or type 2 diabetes mellitus. * Other endocrine disorders that may affect reproductive or metabolic function, including Cushing syndrome, congenital adrenal hyperplasia, androgen-secreting tumors, hyperprolactinemia, or uncontrolled thyroid disease. * Severe liver disease, including cirrhosis or liver failure. * Severe renal impairment, defined as estimated glomerular filtration rate less than 30 mL/min/1.73 m2. * Severe cardiovascular disease, including unstable angina, myocardial infarction within the previous 6 months, or stroke within the previous 6 months. * Use within the previous 3 months of medications that may affect body weight, carbohydrate metabolism, androgen status, or reproductive function, including metformin, oral contraceptives, antiandrogens, gonadotropin-releasing hormone agonists or antagonists, clomiphene citrate, glucocorticoids, thiazolidinediones, or weight-loss drugs. * Current or past eating disorders, including anorexia nervosa, bulimia nervosa, or binge eating disorder. * Mental disorders or cognitive conditions that, in the opinion of the investigator, would preclude safe participation or compliance with study procedures. * Participation in another clinical trial within the previous 3 months. * Refusal or inability to provide written informed consent.

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Conditions

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As listed by the trial registrant

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