Beneficial Effects of Resemena Diet on Anthropometric, Metabolic and Reproductive Profile in Adolescents With Obesity and Polycystic Ovary Syndrome: a Randomized Controlled Intervention Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Total and free (ng/mL)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 13 Years 至 18 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of PCOS in adolescent girls according to the Rotterdam criteria
- •Age 13-18 years,
- •Body mass index (BMI) ≥ 95th percentile
排除标准
- •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)
结局指标
主要结局
Total and free (ng/mL)
时间窗: change between the first day and the sixth month of the study
Participants' serum FSH levels was determined.
Free Androgen Index (FAI)
时间窗: 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)
时间窗: change between the first day and the sixth month of the study
Participants' fasting blood gucose was calculated.
HOMA-IR index
时间窗: 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)
时间窗: change between the first day and the sixth month of the study
Participants' serum DHEA-S levels was determined.
Androstenedione (ng/mL)
时间窗: change between the first day and the sixth month of the study
Participants' serum androstenedione was determined.
Sex hormone binding globulin (SHGB) (nmol/L)
时间窗: change between the first day and the sixth month of the study
Participants' serum SHGB was determined.
Luteinizing hormone (LH) (IU/L)
时间窗: change between the first day and the sixth month of the study
Participants' serum LH levels was determined.
Follicle-stimulating hormone (FSH) (IU/L)
时间窗: change between the first day and the sixth month of the study
Participants' serum FSH levels was determined.
The Ferriman-Gallwey score (FGS)
时间窗: 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)
时间窗: 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)
时间窗: change between the first day and the sixth month of the study
Participants' serum 17-OH progesterone was determined.
fasting insulin (IU/ml)
时间窗: change between the first day and the sixth month of the study
Participants' fasting insulin was calculated.
QUICKI index
时间窗: change between the first day and the sixth month of the study
Participants' QUICKI index was calculated using the 1/\[log(fasting insulin in μU/ml)+log(fasting glucose in mg/dl)\].
次要结局
- Total cholesterol (mg/dl) composition(change between the first day and the sixth month of the study)
- high-density lipoprotein (HDL-C) (mg/dl)(change between the first day and the sixth month of the study)
- low-density lipoprotein (LDL) (mg/dl)(change between the first day and the sixth month of the study)
- triglyceride (mg/dl)(change between the first day and the sixth month of the study)
- high-sensitivity CRP (HsCRP)(mg/l)(change between the first day and the sixth month of the study)
- tumor necrosis factor-alpha (TNF-α) (pg/ml)(change between the first day and the sixth month of the study)
- . Waist circumference in cm(change between the first day and the sixth month of the study)
- BMI = body mass index (kg/m2)(change between the first day and the sixth month of the study)
- interleukin-6 (IL-6) (pg/ml)(change between the first day and the sixth month of the study)
- Weight in kilograms(change between the first day and the sixth month of the study)
- Height in meters(change between the first day and the sixth month of the study)
- Neck circumference in cm(change between the first day and the sixth month of the study)
- body composition analysis(change between the first day and the sixth month of the study)
研究者
Esra Döğer
Principal Investigator
Gazi University