Effects of a Low Calorie Mediterranean Ketogenic Diet in Women With Polycystic Ovary Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Body Weight
研究概览
简要总结
The aim of the study is to investigate the effects of a low calorie Mediterranean ketogenic diet on Polycystic Ovary Syndrome (PCOS) related outcomes.
详细描述
Fourteen overweight women with diagnosis of Polycystic Ovary Syndrome (PCOS) will undergo to a low calorie ketogenic Mediterranean diet with phyoextracts (KEMEPHY) for 12 week. Changes in body weight, body mass index (BMI), fat body mass (FBM), lean body mass (LBM), visceral adipose tissue (VAT), insulin, glucose, HOMA-IR, total cholesterol, low density lipoprotein (LDL), high density lipoprotein (HDL(, triglycerides (TGs), total and free testosterone, luteinizing hormone (LH), follicle stimulating hormone (FSH); dehydroepiandrosterone sulfate (DHEAs), estradiol, progesterone, sex hormone binding globulin (SHBG) and Ferriman Gallwey score will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •diagnosis of PCOS according Rotterdam Criteria (at least 2 of 3 between
- •oligo/anovulation
- •hyperandrogenism
- •clinical (hirsutism or less commonly male pattern alopecia) or biochemical (raised FAI or free testosterone) polycystic ovaries on ultrasound Other inclusion criteria
- •fertile age (18-45 years);
- •BMI> 25 kg/m2,
- •desire to lose weight;
- •acceptance not to use contraceptives during the experimental period
排除标准
- •pregnancy and lactation,
- •hormonal therapy and/or insulin-sensitizers in the last 2 months,
- •hepatic, renal and heart diseases
结局指标
主要结局
Body Weight
时间窗: 12 weeks
Body weight will be measured by an electronic scale
Fat body mass
时间窗: 12 weeks
will be analysed by Dual X Ray Absorptiometry (DEXA) Hologic HorizonTM QDR RSeries Bedford, Massachusetts, USA
LH
时间窗: after 12 weeks
LH will be measured by immunochemiluminescent method (Roche Cobas e601, Roche Diagnostics, Mannheim, Germany)
FSH
时间窗: 12 weeks
FSH will be measured by immunochemiluminescent method (Roche Cobas e601, Roche Diagnostics, Mannheim, Germany)
Total testosterone
时间窗: 12 weeks
Total testosterone will be measured by immunochemiluminescent method (Roche Cobas e601, Roche Diagnostics, Mannheim, Germany)
Insulin
时间窗: 12 weeks
Insulin will be measured by immunochemiluminescent method (Roche Cobas e601, Roche Diagnostics, Mannheim, Germany)
DHEAS
时间窗: 12 weeks
DHEAS will be measured by immunochemiluminescent method (Roche Cobas e601, Roche Diagnostics, Mannheim, Germany)
progesterone
时间窗: 12 weeks
progesterone will be measured by immunochemiluminescent method (Roche Cobas e601, Roche Diagnostics, Mannheim, Germany)
estradiol
时间窗: 12 weeks
estradiol will be measured by immunochemiluminescent method (Roche Cobas e601, Roche Diagnostics, Mannheim, Germany)
SHBG
时间窗: 12 weeks
SHBG will be measured by immunochemiluminescent method (Roche Cobas e601, Roche Diagnostics, Mannheim, Germany)
Hirsutism .
时间窗: 12 weeks
we will use Ferriman Gallwey Score. A score of 1 to 4 is given for nine areas of the body. A total score less than 8 is considered normal, a score of 8 to 15 indicates mild hirsutism, and a score greater than 15 indicates moderate or severe hirsutism. A score of 0 indicates absence of terminal hair.
HOMA
时间窗: 12 weeks
HOMA-IR will be calculated according to the formula "insulinemia (μU/mL) x glycemia (mmol/L)/22.5
blood glucose
时间窗: 12 weeks
blood glucose will be measured by enzymatic method with esokinase (Roche Cobas e702, Roche Diagnostics, Mannheim, Germany)
次要结局
- Ketone bodies(12 weeks)
- total cholesterol(12 weeks)
- Triglycerides(12 weeks)
- HDL cholesterol(12 weeks)
- LDL cholesterol(12 weeks)
研究者
Antonio Paoli
Professor
University of Padova