Omega-3 Supplementation for LIver VolumE Reduction Study (OLIVER) Study
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Changes of Liver Volume Facilitating Access during Bariatric Surgery
研究概览
简要总结
Omega-3 has been postulated to reduce hepatic steatosis by reducing lipogenic gene expression, exerting anti- inflammation action, reducing oxidative stress and improving glycemic control.
A recent meta-analysis by Parker et al.[1] found that omega-3 supplementation is associated with improvement in liver fat content as well as on Aspartate Aminotransferase (AST) levels. Omega-3 supplementation has also found to be useful in reducing blood triglyceride levels [2].
Recent studies by Iannelli et al. (2013) and Abidin et al.(2017) have also found that a 1 month supplementation of 1.5g/day and 2g/day of omega-3 supplementation resulted in reduced hepatic volume of 20% and 34.88 cm3 respectively.
The investigator's hypothesis is that a 4 weeks course of Omega-3 (2 capsules of Blackmores Omega Daily Concentrated Fish Oil per day; Each capsule Concentrated omega-3 triglycerides- fish 1000mg containing Omega-3 Marine Triglycerides 600mg as: 360mg Eicosapentaenoic acid (EPA), 240mg Docosahexaenoic acid (DHA)) taken as supplement, without any other dietary intervention pre Bariatric Surgery decreases significantly liver volume and facilitate access during surgery. And that shrinkage of liver volume also translates to improve biochemical parameters of fatty liver disease
详细描述
A total of 50 subjects booked for Bariatric Surgery with BMI up 45 will be recruited. Patients with pre-existing liver disease, excessive alcohol consumption and significant central obesity will be excluded.
Ultrasound examination of the liver with liver volume measurement, and blood tests, including Liver Function Tests (LFT) and platelet counts,is performed as part of the pre surgery work up.
The subjects are then given 4 weeks of Omega-3 supplements (2 capsules of Blackmores Omega Daily Concentrated Fish Oil per day: Concentrated omega-3 triglycerides- fish 1000mg (600mg Eicosapentaenoic acid (EPA), 1400mg Docosahexaenoic acid (DHA)).
Just before Surgery, a repeat of ultrasound examination and measurement of liver volume is carried out, as well as a repeat liver panel and platelet count.The subjects will have their weight and body composition recorded as well at this time.
At the time of the surgery, the surgeon makes a subjective assessment of the left lobe liver volume on a scale of 1 to 5, 5 being the largest. Additionally,ease of access to area under the left lobe of the liver is also subjectively assessed, on a scale of 1 to5, 5 being the most difficult.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects qualifying and scheduled for Bariatric Surgery (as according to Singapore Health Promotion Board- Ministry of Health Obesity Clinical Practice GuidelineJune 2016)
- •BMI <45 with no significant central obesity.
- •Has no pre-existing liver disease, or excess alcohol consumption.
排除标准
- •Pre-existing liver disease
- •Excessive alcohol consumption
- •Prior history of allergy to omega-3 products, salmon or other- related products
- •central obesity
结局指标
主要结局
Changes of Liver Volume Facilitating Access during Bariatric Surgery
时间窗: After 4 weeks of Omega-3 supplement
To demonstrate that Omega-3 oil taken as supplement, without any other dietary intervention pre Bariatric Surgery significantly changes liver volume and facilitates access during surgery.
次要结局
- Change in Biochemical parameters (serum AST levels) of fatty liver disease(After 4 weeks of Omega-3 supplement)
- Change in Biochemical parameters (serum ALT levels) of fatty liver disease(After 4 weeks of Omega-3 supplement)
- Change in Biochemical parameters (serum Platelet levels) of fatty liver disease(After 4 weeks of Omega-3 supplement)