Health Effects of Cetoleic Acid (Helseeffekter av Ketolinsyre)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- EPA and DHA in plasma
研究概览
简要总结
In this Randomized Controlled Trial (RCT) we want to study how supplements of cetoleic acid ( C22:n1-11) (intervention) affect the conversion of alpha-linolenic acid (ALA) to EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) in healthy subjects, compared to supplements with a low concentration of cetoleic acid (control).
Our primary endpoints are changes in the concentration of EPA and DHA in plasma and red blood cells.
详细描述
This is a randomized double-blinded controlled trial ( randomized 1:1). Study population: healthy men and women 20-70 years, BMI 20-35 kg/m2.
Study design:
- 3 weeks run-in-period where all participants consume control capsules every morning.
- Randomization intervention: control (1:1). All participants consume their capsules (control or intervention) for 4 weeks.
The intervention oil consists of a fish oil high in cetoleic acid and the control oil is a mix of different oils and low in cetoleic acid.
Power calculation and sample size:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
All participant, the major investigator, study coordinator and the study staff are blinded for the randomizing. The capsules and capsule containers will only be identifiable by the ID (identifying) numbers on the containers.
Allocation of participants to the specific intervention group is carried out by a statistician and one person not involved in conducting the study.
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI 20-35kg/m2
- •opportunity to meet for 3 visits at the Department of Nutrition, University of Oslo, during the study period.
排除标准
- •Chronic disease (liver/kidney/metabolism)
- •Alcohol overconsumption (>40g/day)
- •Diabetes and high fasting blood glucose
- •Pregnant/ breastfeeding or planning pregnancy during the study period
- •High fish intake (>3 meals/week).
- •Blood donation during the study period
- •Difficulty following the study protocol.
- •Smoking/snuffing
- •Regularly use of anti-inflammatory drugs
- •Regularly use of omega-3 supplements /cod liver oil.
结局指标
主要结局
EPA and DHA in plasma
时间窗: 4 weeks intervention
EPA and DHA concentration in plasma measured at baseline and and after 4 week intervention (and as a "control measurement" at the screening visit)
EPA and DHA in red blood cells
时间窗: 4 weeks
EPA and DHA concentration and omega 3 index (EPA+DHA/total fatty acids) in red blood cells measured at baseline and and after 4 week intervention (and as a "control measurement" at the screening visit)
次要结局
- Lipid profile- Lipoproteins(4 weeks)
- Gene expression(4 weeks)
- Resolvins(4 weeks)
- Metabolome(4 weeks)
- Lipid profile- Triglycerides(4 weeks)
- Lipid profile- Cholesterol(4 weeks)
- Lipid profile- Apolipoproteins(4 weeks)
- Inflammatory markers(4 weeks)
- Pain sensitivity(4 weeks)
研究者
Kirsten Holven
Professor
University of Oslo