NCT07598344Not yet recruiting
MeDiApp-PCOS: A Mobile Mediterranean Diet App for Women With Polycystic Ovary Syndrome
Randomized Controlled Trial of a Mobile Application With Personalized Mediterranean Diet-Based Recommendations in Women With Polycystic Ovary Syndrome
Source: ClinicalTrials.gov · Last updated 3 Jun 2026
Brief summary (registry, in English)
This randomized clinical trial will test whether a mobile application with personalized Mediterranean diet-based recommendations can improve health outcomes in women with polycystic ovary syndrome compared with standard lifestyle advice. Participants will be assigned to either the mobile application group or the standard lifestyle advice group. The primary outcomes are change in LDL cholesterol and change in body mass index after 3 months. Secondary outcomes include changes in metabolic and hormonal measures, quality of life, treatment adherence, and ovulatory function assessed through 6 months.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 13 May 2026
- Start date
- 13 May 2026
- Primary completion date
- 30 Dec 2028
- Lead sponsor
- Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
- NCT number
- NCT07598344
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 13 May 2026 to the primary completion date, 30 Dec 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Participation in another clinical trial within the previous 3 months.
Other illness
- 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.
- 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.
Other
- Pregnancy or breastfeeding at the time of enrollment.
- Planning pregnancy during the study period.
- Refusal or inability to provide written informed consent.
Who the study is looking for
- 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.
Age in the registry: 18 years to 45 years · Sex: Female · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.