Dietary Fish Oil Intervention in Polycystic Ovary Syndrome
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Plasma Triglycerides and apoB-lipoprotein remnants in non-fasting and fasted state
研究概览
简要总结
The primary objective in this proposed study is to determine the effect of dietary fish oil supplementation compared to standard care metformin treatment, and fish oil in combination with metformin on plasma lipids and apoB-remnant lipoprotein metabolism in overweight-obese young women with PCOS.
详细描述
Specific Objectives;
- To determine the effect of dietary fish oil supplementation, metformin, and fish oil in combination with metformin on fasting and non-fasting plasma TG, apoB48 and apoB100-lipoprotein concentrations.
- To determine the physiological mechanisms associated with the effect of dietary fish oil supplementation and metformin on in vivo plasma lipid and apoB-lipoprotein kinetics. We will quantitate the in vivo production and kinetics of plasma TG, apoB48 and apoB100-lipoproteins in plasma and isolated lipoprotein fractions, using established methods.
- To explore the effects of dietary fish oil supplementation, metformin and fish oil in combination with metformin, on plasma insulin and testosterone, and the association with changes in plasma lipids and apoB-lipoprotein metabolism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
This is a randomized open-label parallel study in overweight/obese young women with PCOS, in which the participant will be randomly assigned to one of three treatment arms
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age at time of enrollment > 18 to <30 years
- •Diagnosis of PCOS: clinical and/or biochemical hyperandrogenemia and menstrual dysfunction and the exclusion of other disorders.
- •Overweight-obese (BMI >25 kg/m2) high-risk metabolically-resistant young women.
- •Elevated fasting plasma TG (>150 mg/dL) and apoB48-remnant cholesterol lipoproteins (>20 ug/ml).
- •Impaired insulin sensitivity (glucose 100-125 mg/dL and/or insulin >15 (uM/ml); and
- •May be diagnosed with T2D (blood glucose >126 mg/dL).
排除标准
- •Pregnancy
- •Lactating women
- •Recent illness that the investigator determines to pose a potential risk for the participant
- •Concomitant medications that influence metabolism (e.g. statins)
- •Excessive alcohol consumption, as determined by the investigator.
研究组 & 干预措施
Fish Oil
Fish oil capsules 1200mg 6 tablets/day 12 weeks
干预措施: Fish Oil (Dietary Supplement)
Metformin
Metformin tablets (500 mg) 2/day 12 weeks
干预措施: Metformin (Drug)
Fish Oil and Metformin
Combo of other 2 arms
干预措施: Fish Oil and Metformin (Combination Product)
结局指标
主要结局
Plasma Triglycerides and apoB-lipoprotein remnants in non-fasting and fasted state
时间窗: At baseline and postintervention at 12 weeks
reported as mean +/- SEM
次要结局
- Plasma hormones, testosterone, SHBG, Estrogen(At baseline and postintervention at 12 weeks)
- Plasma insulin and glucose(At baseline and postintervention at 12 weeks)