Androgen; Hypersecretion, Diet, Healthy, Obesity, Polycystic Ovary Syndrome
Conditions
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.
Interventions
BEHAVIORALintervention diet
The Resmena diet: It was characterized by a higher meal frequency, consisting of seven meals/d (including breakfast, lunch, dinner, and two snacks in the morning and two snacks in the afternoon), and by a different macronutrient distribution; 40% total energy value from CHO, 30% from proteins and 30% from lipids. This pattern tried to reinforce high n-3 polyunsaturated FA (n-3 PUFA) and high natural antioxidant food consumption and promoted low GL CHO intake as well as a high adherence to the Mediterranean diet. It also maintained a healthy FA profile and a cholesterol content of less than 300 mg/day. * Daily meal plans were created according to the energy intake of the participants and sent to the participants via social media every week. Participants were asked to keep 3-day diet records to evaluate their compliance with the diet and were invited to the research center once a month to be checked.
BEHAVIORALcontrol diet
Control diet: It was based on the American Heart Association (AHA) guidelines, including 3-5 meals per day, a macronutrient distribution of 55% total energy value from carbohydrates, 15% proteins, and 30% lipids, a healthy fatty acids (FA) profile and a cholesterol consumption lower than 300 mg/day. \- Daily meal plans were created according to the energy intake of the participants and sent to the participants via social media every week. Participants were asked to keep 3-day diet records to evaluate their compliance with the diet and were invited to the research center once a month to be checked
Sponsors
Gazi University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
All cases were assigned codes. The codes were sealed in opaque envelops and kept in statistician ofce until the last patient completed the study.Study personnel involved in the analysis of the results (endocrinologist, radiologist, nurse, and laboratory technicians) were blinded to group assignments.
Intervention model description
single-blind, randomized, two-arm, parallel six-month dietary intervention.
Eligibility
Sex/Gender
FEMALE
Age
13 Years to 18 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| QUICKI index | change between the first day and the sixth month of the study | Participants' QUICKI index was calculated using the 1/\[log(fasting insulin in μU/ml)+log(fasting glucose in mg/dl)\]. |
| 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. |
| Total and free (ng/mL) | change between the first day and the sixth month of the study | Participants' serum FSH levels was determined. |
| Prolactin (ng/mL) | change between the first day and the sixth month of the study | Participants' serum prolactin levels was determined. |
| 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. |
| 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. |
| Sex hormone binding globulin (SHGB) (nmol/L) | change between the first day and the sixth month of the study | Participants' serum SHGB 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 = \[(Total testosterone/ SHBG) × 100\] |
| 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. |
| fasting blood glucose (mg/dl) | change between the first day and the sixth month of the study | Participants' fasting blood gucose was calculated. |
| fasting insulin (IU/ml) | change between the first day and the sixth month of the study | Participants' fasting insulin 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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. |
| 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. |
| Neck circumference in cm | change between the first day and the sixth month of the study | Neck circumference was measured |
| . Waist circumference in cm | change between the first day and the sixth month of the study | waist 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) |
| Height in meters | change between the first day and the sixth month of the study | Height was measured |
Countries
Turkey (Türkiye)
Outcome results
None listed