The Combined Effects of omega3 Fatty Acids and Curcumin Supplementation on Gene Expression and Serum Levels of Some Inflammatory and Endothelial Factors in Migraine Patients
试验速览
- 阶段
- 4 期
- 入组人数
- 80
- 主要终点
- headache attack
研究概览
简要总结
The aim of this study is to determine the effects of omega 3 fatty acid, curcumin and their combination or placebo for 2 months on the gene expression of COX-2, iNOS, TNF-α, IL-1β, IL-6, VCAM-1 and ICAM-1 in the peripheral blood mononuclear cell (PBMC) and serum levels of COX-2, iNOS, TNF-α, IL-1β, IL-6, VCAM-1, ICAM-1 and hsCRP of migraine patients.
详细描述
The aim of this study is to determine the effects of omega 3 fatty acid, curcumin and their combination or placebo for 2 months on the gene expression of cyclooxygenase-2 (COX-2), inducible nitric oxide synthase (iNOS), Tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β), interleukin-6 (IL-6), vascular cell adhesion molecule-1 (VCAM-1) and intercellular adhesion molecule-1 (ICAM-1) in the peripheral blood mononuclear cell (PBMC) and serum levels of COX-2, iNOS, TNF-α, IL-1β, IL-6, VCAM-1, ICAM-1 and high-sensitivity C-reactive protein (hsCRP) of migraine patients.
In this randomized, double-blind clinical trial, placebo-controlled study, 80 women and men with migraine are enrolled from the Iranian Center of Neurological Research. At the start of study, all participants will sign informed consent and complete a general information form. 24-hour food recall for 3 days will be taken from the patients at the beginning and the end of the study. Selected samples by using stratified randomization method based on sex, gender and body mass index (BMI) are classified into 4 groups: 1) receiving omega 3 fatty acid supplement and curcumin supplement 2) receiving omega 3 fatty acid supplement and curcumin placebo 3) receiving curcumin supplement and omega 3 fatty acid placebo 4) receiving omega 3 fatty acid placebo and curcumin placebo.
The omega 3 fatty acid supplement group will receive 1200 mg Eicosapentaenoic acid (EPA) and 600 mg Docosahexaenoic acid (DHA) totally 1800 mg daily for 2 months. The curcumin supplement group will receive 1000 mg curcumin daily for 2 months. The omega 3 fatty acid placebo group will also receive placebo containing 1800 mg edible paraffin oil and curcumin placebo group will receive 1000 mg starch powder both similar in terms of color, shape and size. participants are advised to maintain their diet, level of physical activity and medication dose during the study. Blood samples will be collected after anthropometric parameter measuring then target biochemical parameters, gene expression and serum levels and physical activity will be measured before and after the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •migraine patients 20- 50 years old
- •body mass index more than 18.5
- •avoidance of dietary supplements, vitamins and herbal products at least 4-6 weeks before and throughout the intervention
- •willingness to participation
排除标准
- •sensitivity to omega 3 fatty acid and curcumin
- •pregnancy and lactation
- •sever change in regular diet and life style
- •change in type and dosage of regular medication (s)
- •inflammatory disease which need take anti inflammatory drugs over than 2 weeks
结局指标
主要结局
headache attack
时间窗: Change frome baseline at 2 months
次要结局
- COX-2 gene expression(Change frome baseline at 2 months)
- serum COX-2(Change frome baseline at 2 months)
- serum iNOs(Change frome baseline at 2 months)
- serum VCAM-1(Change frome baseline at 2 months)
- serum ICAM-1(Change frome baseline at 2 months)
- serum TNF-α(Change frome baseline at 2 months)
- serum IL-1β(Change frome baseline at 2 months)
- serum IL-6(Change frome baseline at 2 months)
- serum hsCRP(Change frome baseline at 2 months)
- headache duration(Change frome baseline at 2 months)
- headache severity(Change frome baseline at 2 months)
- IL-6 gene expression(Change frome baseline at 2 months)
- iNOs gene expression(Change frome baseline at 2 months)
- VCAM-1 gene expression(Change frome baseline at 2 months)
- ICAM-1 gene expression(Change frome baseline at 2 months)
- TNF-α gene expression(Change frome baseline at 2 months)
- IL-1β gene expression(Change frome baseline at 2 months)