Can Oils Derived From Genetically-modified Plants Replace Fish Oil as a Source of Long Chain n-3 Polyunsaturated Fatty Acids in the Human Diet
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Uptake of omega 3 polyunsaturated fatty acids after longer term consumption of fish oil or Camelina seed oil.
研究概览
简要总结
Fish oil and oily fish contain omega 3 long chain polyunsaturated fatty acids known to be beneficial to health. Many people consume little, despite UK government recommendations to eat at least one portion of oily fish per week. Furthermore, despite modest consumption, fish stocks are declining due to over fishing. Therefore, there is a need for an alternative, sustainable and cost efficiently produced dietary source. A seed oil source of these fish oil-type fatty acids has been achieved by adding genes from other plant sources to the oil seed plant Camelina sativa. Camelina sativa, related to mustard and cabbage, has provided seed oil for human consumption for thousands of years. It was the most important oil seed plant in Europe until the 1900's. This research is being done to see if consuming fish oil-type fatty acids in Camelina seed oil allows the body to take up and use the fish oil fatty acids in the same way as it does from fish oil.
详细描述
This research is being done to see if consuming fish oil-type omega 3 long chain polyunsaturated fatty acids in Camelina seed oil allows the body to take up the fish oil fatty acids in the same way as it does from fish oil.
In the first study (A) the Camelina oil will be used in a meal. The volunteers (healthy men and women) will be asked to consume the meal and provide blood samples in the following 6 hours to look at immediate uptake of the fish oil fatty acids. This will be repeated (for comparison) with fish oil.
The second study (B) will look at consumption over a longer period. Volunteers will be asked to consume the Camelina oil daily for 8 weeks and provide blood samples at the visits at the start and end of that period. This will be repeated (for comparison) with fish oil.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female
- •18 to 30 years or 50 to 65 years
- •Body mass index 18.5-30.0 kg/m2
- •Health screening results that are within normal clinical ranges
- •Not consuming fish oil or other oil supplements
- •Not eating more than one oily fish meal per week
- •Willing to adhere to the study protocol
- •Being able to provide written informed consent
排除标准
- •Aged < 18 years; 31-49 years or > 65 years
- •Body mass index < 18.5 or > 30 kg/m2
- •Current smoker
- •Fasting blood cholesterol or glucose concentrations outside the normal concentration range
- •Diagnosed chronic illness (for example diagnosed cardiovascular disease, diabetes, cancer)
- •Use of prescribed medicine to control inflammation
- •Use of prescribed medication to control blood lipids (e.g. statins, fibrates (fenofibrate), Omacor)
- •Use of prescribed medication to control blood pressure (ACE inhibitors, angiotensin 2 receptor blockers, calcium channel blockers, α-inhibitors, thiazide diuretics)
- •Use of fish oil or other oil supplements
- •Chronic gastrointestinal problems (e.g. IBD, coeliac disease, cancer)
- •Pregnant or planning to become pregnant within the study period
- •Participation in another clinical trial
结局指标
主要结局
Uptake of omega 3 polyunsaturated fatty acids after longer term consumption of fish oil or Camelina seed oil.
时间窗: Longer term consumption daily for 8 weeks. Follow up at 8 weeks.
The magnitude of the increase in omega 3 polyunsaturated fatty acids in plasma lipids and blood cells following consumption of modified Camelina seed oil for 8 weeks compared with fish oil.
Uptake of omega 3 polyunsaturated fatty acids after short term consumption of fish oil or Camelina seed oil.
时间窗: Short term consumption - single dose followed over 8 hours
The magnitude of the increase in omega 3 polyunsaturated fatty acids in plasma lipids and blood cells following consumption of modified Camelina seed oil for short (postprandial) period compared with fish oil.
次要结局
- Effect of omega 3 polyunsaturated fatty acid consumption on postprandial inflammatory markers after consumption of fish oil or Camelina seed oil.(Short term consumption - single dose followed over 8 hours)
- Effect of omega 3 polyunsaturated fatty acid consumption for 8 weeks on in vitro immune responses after consumption of fish oil or Camelina seed oil.(Longer term consumption daily for 8 weeks. Follow up at 8 weeks.)