Effect of Magnesium Supplementation on Metabolic Profile and Sex Hormone Levels in Overweight Women With Polycystic Ovary Syndrome.
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Serum insulin level
研究概览
简要总结
This is a double-blind randomized clinical trial which will start at June 2014 and end on June 2015 in Isfahan city. Serum insulin level is considered as a key variable and the sample size calculated 70 persons (35 persons for control group and 35 persons for patient group). Patient group will receive magnesium supplement (250 milligram) and the other group will receive placebo which is similar to the magnesium tablets in color, odor and appearance both for 8 weeks. All subjects will complete 4 physical activity and 4 dietary records. Outcome measurements including sex hormone levels, metabolic and inflammatory profiles will be measured at the beginning and end of the study as well as anthropetric measurements.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Having PCOS according to the Rotterdam criteria,
- •Age between 20-45 years,
- •Lack of pregnancy and lactation,
- •Not having certain regime during last 3 months,
- •Non-smoking,
- •Not having diseases, including: diabetes, cardiovascular , hepatic, renal and thyroid,
- •Not taking supplements,
- •Being overweight (Kg / m 25 ≤ BMI)
排除标准
- •Hormone Therapy,
- •Pregnancy and lactation during the study,
- •Severe weight loss (more than 2.5 kg per month) during the study
结局指标
主要结局
Serum insulin level
时间窗: 8 Weeks
次要结局
- Insulin Resistance(8 weeks)
- Fasting Blood Sugar(8 weeks)
- Quantitative insulin sensitivity check index (Quicki)(8 weeks)
- HOMA-IR(8 weeks)
- HOMA-B(8 weeks)
- High Density Lipoprotein(8 weeks)
- Low Density Lipoprotein(8 weeks)
- Triglyceride(8 weeks)
- Total Cholesterol(8 weeks)
- Androgen(8 weeks)
- Testosterone(8 weeks)
- C-Reactive Protein(8 weeks)
研究者
Leila Azadbakht
Associate Professor
Isfahan University of Medical Sciences