NCT03210805Unknown不适用
Investigating the Effect of 4-week Omega-3 Polyunsaturated Fatty Acid Supplementation on Inflammation
Bethan Hussey0 个研究点目标入组 17 人开始时间: 2017年1月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 17
- 主要终点
- Epigenetic regulation of Cytokine Genes
研究概览
简要总结
Investigate the in vivo effects of n-3 PUFA supplementation on inflammation, gene expression and epigenetic signatures.
Ex vivo stimulation of peripheral blood mononuclear cells (PBMCs) collected pre and post n-3 supplementation and measurement of it's effect on inflammation, gene expression and epigenetic signatures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy males
- •Aged between 18 and 30 years
排除标准
- •Females (Due to differences in cell membrane incorporation of n-3 PUFAs between the sexes and the testing schedule being unable to fit in with menstrual cycle, therefore altering the blood markers that are being measured).
- •Aged below 18 or above
- •Body mass index (BMI; in kg/ m2), below 18 or above
- •Use of vitamin or fish oil supplements in the last 6 months.
- •High habitual oily fish consumption (<4 servings per month).
- •Changes in weight in the past 6 months (Dieting) or planning on changing dietary habits.
- •Habitual use of anti-inflammatory drugs.
- •Self-reported history of diabetes.
- •History of heart disease, coagulation/bleeding disorders, metabolic disease or Serious allergy.
- •Known to have blood-borne virus.
- •Receipt of inoculations within 2 months of starting the study or the intention to receive such during the study.
- •Donation of or intention to donate blood within 8 weeks of the first sample or at any point during the intervention.
结局指标
主要结局
Epigenetic regulation of Cytokine Genes
时间窗: Change from Baseline at 7, 14, 21 and 28 days
Blood Sample
次要结局
- Exercise Questionnaire(Baseline, 7, 14, 21 and 28 days)
- Total Cholesterol(Baseline, 7, 14, 21 and 28 days)
- LDL (Low density lipoprotein)(Baseline, 7, 14, 21 and 28 days)
- Height(Baseline, 7, 14, 21 and 28 days)
- HDL (High density lipoprotein)(Baseline, 7, 14, 21 and 28 days)
- Triglycerides(Baseline, 7, 14, 21 and 28 days)
- Fasting Glucose(Baseline, 7, 14, 21 and 28 days)
- Full Blood Count(Baseline, 7, 14, 21 and 28 days)
- Weight(Baseline, 7, 14, 21 and 28 days)
- Hip Circumference(Baseline, 7, 14, 21 and 28 days)
- Waist Circumference(Baseline, 7, 14, 21 and 28 days)
- Food Diary(Baseline, 7, 14, 21 and 28 days)
- Gene expression of Cytokine Genes(Baseline, 7, 14, 21 and 28 days)
- Systolic and Diastolic Blood Pressure(Baseline, 7, 14, 21 and 28 days)
- Heart rate(Baseline, 7, 14, 21 and 28 days)
- Ethnic background(Baseline, 7, 14, 21 and 28 days)
- ex vivo stimulation of Human Derived Blood Cells(Baseline and 28 days)
研究者
Bethan Hussey
Postgraduate PhD Research Student
Loughborough University
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