Effects of Ketolic Acid on Atherosclerosis Markers in High-risk Patients With Metabolic Syndrome (Effekt av Ketolinsyre på aterosklerosemarkører i høyrisikopasienter Med Metabolsk Syndrom)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 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 the effect of an oil with high concentrations of cetoelic acid (C22:n1-11) (intervention) compared to supplements with a low concentration of cetoleic acid (control), but with equivalent content of EPA og DHA, on plasma levels of epa and dha as well as atherosclerotic markers, glucose, c-peptide and triglycerides in a patient group with a metabolically unfavorable phenotype.
Our primary endpoints are changes in the concentration of EPA and DHA in plasma.
详细描述
This is a randomized double-blinded controlled trial (randomized 1:1). Study population: men and women 20-70 years with a metabolically unfavorable phenotype defined as: triglycerides > 1.7 mmol/L and waist measurement > 80 cm (women) and > 94 cm (men).
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 is consists of an oil high in cetoleic acid and the control oil is low in cetoleic acid. Both the intervention oil and the control oil are a mix of different oils; fish oils, olive oil, "high-oleic sunflower oil" and rapeseed oil so that the content of EPA, DHA and ALA is similar in the two oils.
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
- 否
入选标准
- •Triglycerides > 1.7 mmol/L
- •Waist measurement > 80 cm (women) and > 94 cm (men)
排除标准
- •Chronic disease (liver/kidney/metabolism)
- •Ongoing active cancer treatment
- •Excessive alcohol consumption (>40g/day)
- •Pregnant/breastfeeding or planned pregnancy during the intervention
- •High intake of fish (>3 weekly meals)
- •Level of free thyroxine (T4) and triiodothyronine (T3) outside reference ranges.
- •Hypertension (≥ 160/ 100 mmHg)
- •Total cholesterol > 7.8 mmol/L
- •Blood donation during the intervention period
- •Difficulty following the protocol
- •Smoking or sniffing
- •Regular use (> 1 day/week) of anti-inflammatory drugs
- •Regular use of omega-3 supplements/cod liver oil
- •Drug use other than stable use of statins, hypertension drugs (Ca antagonists, diuretics and beta blockers).
- •Hormonal treatment excluding stable use of thyroxine and birth control pills/contraceptive rod
研究组 & 干预措施
Intervention (Cetoleic acid)
6 x capsules intervention oil (oil = mix of fish oils, olive oil, high-oleic sunflower oil and rapeseed oil) with high content of cetoleic acid (1780 mg/day, estimated: 29,76%) every morning for 4 weeks.
干预措施: Cetoleic acid (Dietary Supplement)
Control oil
6 x capsules control oil (oil= mix of fish oils, olive oil, high-oleic sunflower oil and rapeseed oil) with low content of cetoleic acid (35 mg/day, estimated 0.58%) every morning for 4 weeks.
干预措施: Control oil (Dietary Supplement)
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 after 4 week intervention (and as a "control measurement" at the screening visit)
次要结局
- Inflammatory markers(4 weeks intervention)
- Resolvin(4 weeks intervention)
- Lipid profile(4 weeks intervention)
- Glucose(4 weeks intervention)
- C-peptid(4 weeks intervention)
- Gene expression, metabolome and lipidome(4 weeks intervention)
研究者
Kirsten Bjørklund Holven
Professor
Oslo University Hospital