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 range13 Years – 18 Years

SexFEMALE

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.

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

Sex hormone binding globulin (SHGB) (nmol/L)

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 range13 Years – 18 Years

SexFEMALE

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

Sex hormone binding globulin (SHGB) (nmol/L)