CompletedNot Applicable

Two Different Dietary Interventions for Girls With Polycystic Ovary Syndrome

Turkey (Türkiye)40 participantsStarted 2021-01-01

Plain-language summary

This study was conducted to evaluate the efficacy of the MEtabolic Syndrome REduction in NAvarra (RESMENA) diet versus a control diet based on American Heart Association (AHA) recommendations for the treatment of PCOS in adolescents with obesity and PCOS. A total of 40 adolescents diagnosed with PCOS between the ages of 13-18 years were randomized to either a Resmena or control diet for 6 months. Dietary status, anthropometry, body composition, biochemical parameters, and reproductive endocrine hormones were compared between the 2 groups before and after the intervention.

Who can participate

Age range

13 Years – 18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosis of PCOS in adolescent girls according to the Rotterdam criteria * Age 13-18 years, * Body mass index (BMI) ≥ 95th percentile Exclusion Criteria: * Other endocrine etiological disorders (Cushing's syndrome, congenital adrenal hyperplasia, McCune Albright syndrome, mutations in the glucocorticoid receptor gene, ovarian and adrenal androgen-secreting tumors, hyperprolactinemia, diabetes mellitus, thyroid dysfunction, adrenal, and other endocrine disorders), * Cardiovascular and cerebrovascular diseases, * Hematologic disorders * Liver and kidney failure * Mental disorders * Eating disorders * Contraceptive use in the last 3 months * Use of insulin-sensitizing agents * Use of drugs affecting lipid metabolism (such as fish oil) * Smoking.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Luteinizing hormone (LH) (IU/L)

Timeframe: change between the first day and the sixth month of the study

Follicle-stimulating hormone (FSH) (IU/L)

Timeframe: change between the first day and the sixth month of the study

Total and free (ng/mL)

Timeframe: change between the first day and the sixth month of the study

Prolactin (ng/mL)

Timeframe: change between the first day and the sixth month of the study

Dehydroepiandrosterone sulfate (DHEA-S) (µg/dL)

Timeframe: change between the first day and the sixth month of the study

Androstenedione (ng/mL)

Timeframe: change between the first day and the sixth month of the study

17-hydroxyprogesterone (17-OH progesterone) (ng/mL)

Timeframe: change between the first day and the sixth month of the study

Trial details

NCT IDNCT05768724

SponsorGazi University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12-05

View on ClinicalTrials.gov More Polycystic Ovary Syndrome trials

Plain-language summary

Who can participate

Age range

13 Years – 18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Luteinizing hormone (LH) (IU/L)

Timeframe: change between the first day and the sixth month of the study

Follicle-stimulating hormone (FSH) (IU/L)

Timeframe: change between the first day and the sixth month of the study

Total and free (ng/mL)

Timeframe: change between the first day and the sixth month of the study

Prolactin (ng/mL)

Timeframe: change between the first day and the sixth month of the study

Dehydroepiandrosterone sulfate (DHEA-S) (µg/dL)

Timeframe: change between the first day and the sixth month of the study

Androstenedione (ng/mL)

Timeframe: change between the first day and the sixth month of the study

17-hydroxyprogesterone (17-OH progesterone) (ng/mL)

Timeframe: change between the first day and the sixth month of the study