Clinical trial NCT05768724: Two Different Dietary Interventions for Girls With Polycystic Ovary Syndrome
Official title: Beneficial Effects of Resemena Diet on Anthropometric, Metabolic and Reproductive Profile in Adolescents With Obesity and Polycystic Ovary Syndrome: a Randomized Controlled Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Obesity
Androgen; Hypersecretion
Diet, Healthy
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2023-03-14
Enrollment: 40
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single-blind, randomized, two-arm, parallel six-month dietary intervention.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Luteinizing hormone (LH) (IU/L)
timeFrame: change between the first day and the sixth month of the study
measure: Follicle-stimulating hormone (FSH) (IU/L)
timeFrame: change between the first day and the sixth month of the study
measure: Total and free (ng/mL)
timeFrame: change between the first day and the sixth month of the study
measure: Prolactin (ng/mL)
timeFrame: change between the first day and the sixth month of the study
measure: Dehydroepiandrosterone sulfate (DHEA-S) (µg/dL)
timeFrame: change between the first day and the sixth month of the study
measure: Androstenedione (ng/mL)
timeFrame: change between the first day and the sixth month of the study
measure: 17-hydroxyprogesterone (17-OH progesterone) (ng/mL)
timeFrame: change between the first day and the sixth month of the study
measure: Sex hormone binding globulin (SHGB) (nmol/L)
timeFrame: change between the first day and the sixth month of the study
measure: Free Androgen Index (FAI)
timeFrame: change between the first day and the sixth month of the study
measure: The Ferriman-Gallwey score (FGS)
timeFrame: change between the first day and the sixth month of the study
measure: fasting blood glucose (mg/dl)
timeFrame: change between the first day and the sixth month of the study
measure: fasting insulin (IU/ml)
timeFrame: change between the first day and the sixth month of the study
measure: HOMA-IR index
timeFrame: change between the first day and the sixth month of the study
measure: QUICKI index
timeFrame: change between the first day and the sixth month of the study
Secondary outcomes:
measure: Total cholesterol (mg/dl) composition
timeFrame: change between the first day and the sixth month of the study
measure: high-density lipoprotein (HDL-C) (mg/dl)
timeFrame: change between the first day and the sixth month of the study
measure: low-density lipoprotein (LDL) (mg/dl)
timeFrame: change between the first day and the sixth month of the study
measure: triglyceride (mg/dl)
timeFrame: change between the first day and the sixth month of the study
measure: high-sensitivity CRP (HsCRP)(mg/l)
timeFrame: change between the first day and the sixth month of the study
measure: tumor necrosis factor-alpha (TNF-α) (pg/ml)
timeFrame: change between the first day and the sixth month of the study
measure: interleukin-6 (IL-6) (pg/ml)
timeFrame: change between the first day and the sixth month of the study
measure: Weight in kilograms
timeFrame: change between the first day and the sixth month of the study
measure: Height in meters
timeFrame: change between the first day and the sixth month of the study
measure: BMI = body mass index (kg/m2)
timeFrame: change between the first day and the sixth month of the study
measure: Neck circumference in cm
timeFrame: change between the first day and the sixth month of the study
measure: . Waist circumference in cm
timeFrame: change between the first day and the sixth month of the study
measure: body composition analysis
timeFrame: change between the first day and the sixth month of the study
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Esra Döğer
Study officials:
affiliation: Gazi Univeristy
name: Rukiye BOZBULUT, Dr
role: STUDY_CHAIR
affiliation: Gazi University
name: Mahmut Orhun Çamurdan, prof
role: STUDY_CHAIR
affiliation: Gazi University
name: Aysun Bideci, prof
role: STUDY_DIRECTOR
References: