Two Different Dietary Interventions for Girls With Polycystic Ovary Syndrome

Gazi University

Status: Completed

Conditions: Androgen; Hypersecretion; Polycystic Ovary Syndrome; Obesity; Diet, Healthy

Treatments: Behavioral: control diet; Behavioral: intervention diet

Study type: Interventional

Funder types: Other

Identifiers

NCT05768724

Gazi University Medicine

Details and patient eligibility

About

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.

Full description

The purpose of this study was to investigate the effect of a high meal frequency, low carbohydrate, high protein, high n-3 PUFA, healthy fatty acid and antioxidant content, low glycemic load Resmena diet or a control diet based on AHA recommendations on anthropometric measurements, body composition, insulin resistance, lipid metabolism levels, inflammatory markers and reproductive endocrine levels in adolescents with obesity and PCOS..Randomized controlled study design was used in the study. Patients in the study were allocated to the control and study intervention groups. Participants were invited to face-to-face interviews at the beginning of the study and monthly for 6 months.

Anthropometric measurements, body composition analysis, and a physical activity questionnaire were performed at the beginning and end of the study, and three-day food consumption records and blood samples for the measurement of biochemical parameters were collected. In addition, the physical activity and food consumption records of the participants were repeated in monthly controls and their anthropometric measurements and body composition were analyzed and compared.

Enrollment: 40 patients

Sex: Female

Ages: 13 to 18 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

İntervention group

Experimental group

Description:

METAbolic Syndrome REduction in NAvarra (RESMENA) diet was applied to adolescents with PCOS

Treatment:

Behavioral: intervention diet

conrol group

Experimental group

Description:

American Heart Association (AHA) guidelines based diet was applied to adolescents with PCOS

Treatment:

Behavioral: control diet