The Effect of n-3 PUFA Plant Oil Intake on Human Metabolism:A Randomized Double-Blind Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Changes in vascular inflammation markers
研究概览
简要总结
The findings of previous experiments suggested that polyunsaturated fatty acids(PUFAs) has been linked to anti-hyperlipidemia, and reducing the risk of cardiovascular disease.This is a randomized double-blind trial, aims to study the effect of PUFAs on blood lipids and human metabolism. Firstly, the investigators will investigate the efficacy of mixed plant oil(echium oil, camelina oil, safflower oil) and pure echium oil on improving the levels of blood lipids. Secondly, next generation sequencing (NGS), ultra-high performance liquid chromatography-tandem mass spectrometric (UPLC-MS/MS) and gas chromatography-mass spectrometry detection will be conducted to explore the role of PUFAs on gut microbiota as well as metabolites. Thirdly, single nucleotide polymorphism will be genotyped by Time-of-flight mass spectrometry to find the gene-environment interaction effect.
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
- Double (Participant, Outcomes Assessor)
盲法说明
The all details of groups assignment are arranged and controlled by the research designers. The color, shape, and external packaging of the n-3 polyunsaturated fatty acid and placebo are consistent (faint yellow to yellow oil in transparent soft capsules). Each bottle of capsules will be marked with the name (or identify number) of the participants by research designers. Thus, the grouping of participants is blind to the rest of the researchers (like outcomes assessors).
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 30-60 years of age
- •Marginal elevated blood lipids or hyperlipidemia[Total cholesterol≥5.2 mmol/L(200 mg/dl) or triglyceride≥1.70 mmol/L(150mg/dl) or low density lipoprotein cholesterol≥3.4 mmol/L(130 mg/dl)]
排除标准
- •Pregnancy；
- •Known cardiovascular disease, diabetes, hypertension and any other chronic disease；
- •Known gastrointestinal disease, such as Irritable Bowel Syndrome(IBS), functional bowel disease and so on；
- •Acute or chronic inflammatory conditions;
- •Liver or kidney dysfunction;
- •An unwillingness to discontinue nutritional supplements；
- •Use of lipid-lowering, antiinflammatory, antidepressant, or blood pressure medication;
- •Evidence of drug or alcohol abuse；
- •Take antibiotics or probiotics in the last three months.
研究组 & 干预措施
Placebo oil
Ingredients: Corn oil, 500mg per capsule
干预措施: Placebo oil (Dietary Supplement)
Echium oil
Ingredients: Echium oil,500mg per capsule
干预措施: Echium oil (Dietary Supplement)
Mixed oil
Ingredients:Mixed oil(Echium oil,camelina oil,safflower oil) 500mg per capsule
干预措施: Mixed oil (Dietary Supplement)
结局指标
主要结局
Changes in vascular inflammation markers
时间窗: At 0 week, 4th week, 12th week in intervention period
Fasting plasma C-reactive protein, soluble intercellular adhesion molecule-1, soluble vascular cell adhesion molecule-1, soluble E-selectin
Changes in blood lipids profile
时间窗: At 0 week, 4th week, 12th week in intervention period
Fasting serum total cholesterol, low density lipoprotein, high density lipoprotein and triglycerides
次要结局
- single nucleotide polymorphism genotype(At 0 week)
- Changes of microbiota metabolite in fecal(At 0 week, 4th week, 12th week in intervention period)
- Changes in gut microbiota(At 0 week, 4th week, 12th week in intervention period)
- Changes in plasma metabolites(At 0 week, 4th week, 12th week in intervention period)
研究者
Liegang Liu
Professor
Huazhong University of Science and Technology