Two Different Dietary Interventions for Girls With Polycystic Ovary Syndrome

Not Applicable

Completed

• Conditions: Androgen; Hypersecretion; Diet, Healthy; Polycystic Ovary Syndrome; Obesity
• Interventions: Behavioral: intervention diet; Behavioral: control diet

• Registration Number: NCT05768724
• Lead Sponsor: Gazi University

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.

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2021-12-05
• Study Completion: 2022-02-01
• Study First Submitted: 2023-02-22
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-03
• Last Update Submitted: 2023-03-03
• Study First Posted: 2023-03-14
• Last Update Posted: 2023-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
İntervention group	intervention diet	METAbolic Syndrome REduction in NAvarra (RESMENA) diet was applied to adolescents with PCOS
conrol group	control diet	American Heart Association (AHA) guidelines based diet was applied to adolescents with PCOS

Primary Outcome Measures

Name	Time	Method
Total and free (ng/mL)	change between the first day and the sixth month of the study	Participants' serum FSH levels was determined.
Free Androgen Index (FAI)	change between the first day and the sixth month of the study	Free Androgen Index (FAI) was calculated according to the equation FAI = \[(Total testosterone/ SHBG) × 100\]
fasting blood glucose (mg/dl)	change between the first day and the sixth month of the study	Participants' fasting blood gucose was calculated.
HOMA-IR index	change between the first day and the sixth month of the study	Participants' HOMA-IR index value was calculated using the "fasting blood glucose (mmol/L) x fasting insulin (μU/mL)/22.5" formula
Dehydroepiandrosterone sulfate (DHEA-S) (µg/dL)	change between the first day and the sixth month of the study	Participants' serum DHEA-S levels was determined.
Androstenedione (ng/mL)	change between the first day and the sixth month of the study	Participants' serum androstenedione was determined.
Sex hormone binding globulin (SHGB) (nmol/L)	change between the first day and the sixth month of the study	Participants' serum SHGB was determined.
Luteinizing hormone (LH) (IU/L)	change between the first day and the sixth month of the study	Participants' serum LH levels was determined.
Follicle-stimulating hormone (FSH) (IU/L)	change between the first day and the sixth month of the study	Participants' serum FSH levels was determined.
The Ferriman-Gallwey score (FGS)	change between the first day and the sixth month of the study	The Ferriman-Gallwey score (FGS) was used to evaluate hirsutism.
Prolactin (ng/mL)	change between the first day and the sixth month of the study	Participants' serum prolactin levels was determined.
17-hydroxyprogesterone (17-OH progesterone) (ng/mL)	change between the first day and the sixth month of the study	Participants' serum 17-OH progesterone was determined.
fasting insulin (IU/ml)	change between the first day and the sixth month of the study	Participants' fasting insulin was calculated.
QUICKI index	change between the first day and the sixth month of the study	Participants' QUICKI index was calculated using the 1/\[log(fasting insulin in μU/ml)+log(fasting glucose in mg/dl)\].

Secondary Outcome Measures

Name	Time	Method
Total cholesterol (mg/dl) composition	change between the first day and the sixth month of the study	Participants' serum total cholesterol was determined.
high-density lipoprotein (HDL-C) (mg/dl)	change between the first day and the sixth month of the study	Participants' serum HDL-C was determined.
low-density lipoprotein (LDL) (mg/dl)	change between the first day and the sixth month of the study	Participants' serum LDL-C was determined.
triglyceride (mg/dl)	change between the first day and the sixth month of the study	Participants' serum triglyceride was determined.
high-sensitivity CRP (HsCRP)(mg/l)	change between the first day and the sixth month of the study	Participants' serum HsCRP was determined.
tumor necrosis factor-alpha (TNF-α) (pg/ml)	change between the first day and the sixth month of the study	Participants' serum TNF-α determined.
. Waist circumference in cm	change between the first day and the sixth month of the study	waist circumference was measured
BMI = body mass index (kg/m2)	change between the first day and the sixth month of the study	BMI = \[body weight (kg)/(height \[m\])2\]' was calculated
interleukin-6 (IL-6) (pg/ml)	change between the first day and the sixth month of the study	Participants' serum IL-6 determined.
Weight in kilograms	change between the first day and the sixth month of the study	Body weight measurement was made.
Height in meters	change between the first day and the sixth month of the study	Height was measured
Neck circumference in cm	change between the first day and the sixth month of the study	Neck circumference was measured
body composition analysis	change between the first day and the sixth month of the study	body composition analysis (fat mass /kg), fat percentage (%), fat-free mass (kg)) were made by using the InBody 720 (1-1000 kHz; InBody Co., Ltd. Korea)

Trial Locations

Locations (1)

Esra Döğer; 🇹🇷 Ankara, Turkey