Role of EPA and DHA in Fish Oil on Inflammation and Lipoprotein Metabolism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Interleukin-6 (IL-6)
研究概览
简要总结
The objective of this study is to provide critical information regarding both common and distinctive roles of EPA and DHA in systemic inflammation and lipid metabolism.
详细描述
This is a randomized, placebo-controlled, double-blind, crossover study of the effects of EPA and DHA on inflammation and lipid metabolism in 24 men and women with metabolic syndrome. The study will characterize the effects of EPA alone and DHA alone, relative to each other and to placebo, on plasma biomarkers of inflammation, inflammatory cell activation and gene expression, and plasma lipid and lipoprotein levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •fasting plasma TG levels between 150 and 500 mg/dL
- •C-reactive protein (CRP) levels ≥2 µg/mL
- •at least one of the following criteria for the definition of metabolic syndrome:
- •abdominal obesity (waist circumference >40 inches in men and >35 inches in women),
- •hypertension (blood pressure ≥130/≥85 mmHg or use of anti-hypertensive medications), and
- •fasting glucose ≥110 mg/dL.
排除标准
- •high-fish diets (>2 fish meals/week)
- •taking fish oil supplements or supplements containing EPA or DHA
- •allergy to sardines
- •allergy to sunflower oil
- •regular use of anti-inflammatory medications (NSAID, COX inhibitors, corticosteroids)
- •anticoagulant therapy
- •alcohol consumption >7 drinks/week
- •uncontrolled thyroid dysfunction
- •insulin-dependent type 2 diabetes mellitus
- •kidney or liver disease
- •alterations in coagulation
- •use of lipid altering medications
研究组 & 干预措施
Placebo
3000 mg high oleic acid sunflower oil/day; 750 mg high oleic acid sunflower oil/capsule; subjects instructed to take 2 capsules by mouth in the morning and 2 in the evening with meals during 4 week long lead-in phase.
干预措施: sunflower oil (Dietary Supplement)
DHA intervention
Subjects randomized to 3000 mg DHA/day provided as DHA 750 mg/capsule will instructed to take 2 capsules by mouth in the morning and 2 in the evening with meals for 10 weeks.
干预措施: DHA (Dietary Supplement)
EPA intervention
Subjects randomized to receive 3000 mg EPA/day, provided as EPA 750 mg/capsule will be instructed to take 2 capsules by mouth in the morning and 2 in the evening with meals for 10 weeks.
干预措施: EPA (Dietary Supplement)
结局指标
主要结局
Interleukin-6 (IL-6)
时间窗: 10 weeks
plasma levels in pg/mL
Low Density Lipoprotein Cholesterol (LDL-C)
时间窗: 10 weeks
plasma levels in mg/dL
Tumor Necrosis Factor Alpha (TNF-alpha)
时间窗: 10 weeks
plasma levels in pg/mL
次要结局
未报告次要终点
研究者
Stefania lamon-Fava
Scientist I, Associate Professor
Tufts University