A Clinical Trial to Measure the Effect of DHA-enriched Fish Oils on Blood Pressure, Heart Rate Variability and Liver Fat Content in the Polycystic Ovary Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 24 hour ambulatory systolic blood pressure
研究概览
简要总结
We hypothesise that fish oils will have a beneficial effect on cardiometabolic parameters in women with PCOS. The purpose of this study therefore is to examine the effects of fish oils on blood pressure, heart rate variability and liver fat content in obese women with the polycystic ovary syndrome.
详细描述
The prevalence of abnormalities of blood pressure (ABP), variability of heart rate (HRV) and liver fat content is increased in women with the polycystic ovary syndrome (PCOS). We hypothesise that fish oils will have a beneficial effect on these endpoints and other cardiometabolic parameters such as cholesterol and liver function in women with PCOS. This crossover study of 40 obese women with PCOS will therefore examine the effects of fish oils on the above parameters compared with placebo (olive oil). Subjects with PCOS who have participated in previous studies with this research group will be approached for recruitment, as will eligible subjects within the endocrine clinics of the chief and co-investigators.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Overweight/obese women with PCOS as per 1990 NIH criteria (see below)
- •Non-smokers
- •Age>18 years, premenopausal
- •Acceptable to have/be on treatment for type 2 diabetes mellitus and/or dyslipidaemia
- •Acceptable to be taking the oral contraceptive pill
排除标准
- •Uncontrolled hypertension (BP>160/100mmHg)
- •Known co-morbidities including liver or renal disease
- •Already taking fish oil supplements
- •Other intercurrent illness (major surgery, CV event)
- •Alcohol intake >20g/day
- •Pregnancy
- •Any metallic implant (contraindication for MRI).
研究组 & 干预措施
1
20/50 fish oil, 1000mg capsules, Ocean Nutrition 2050,4g/day.
干预措施: Ocean Nutrition 2050 (Dietary Supplement)
2
olive oil capsules
干预措施: Olive oil capsules (Dietary Supplement)
结局指标
主要结局
24 hour ambulatory systolic blood pressure
时间窗: week 8 and week 24
次要结局
- 24 hour heart rate variability(week 8 and week 24)
- liver fat content (MRI)(week 8 and week 24)