Effects of Plant and Marine Omega-3 (w-3) Fatty Acids on Inflammatory Markers In Insulin Resistant Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Change from baseline in inflammatory markers (MCP-1, IL-6, and sICAM-1) at 8 weeks.
研究概览
简要总结
The major purpose of this study is to examine the effect of two sources of dietary omega-3 fatty acids, each given at two doses, on potential health benefits related to cardiovascular disease prevention. The two sources of dietary omega-3 fatty acids will be fish oil, and flaxseed oil.
详细描述
The primary aim of this study is to examine the effect of two sources of dietary omega-3 fatty acids, each given at two doses, on potential health benefits related to cardiovascular disease prevention. The two sources of dietary omega-3 fatty acids will be fish oil, and flaxseed oil. Each will be given at a lower dose that could realistically be achieved from food sources alone, and at a higher dose that could not realistically be achieved from food alone and would require supplementation. The outcomes being studied are markers of inflammation. The subjects being studied are those with elevated risk factors for diabetes and heart disease that meet the criteria for the "metabolic syndrome". These are the people who are currently not diabetic, and who have not been diagnosed yet with heart disease, who are at risk of developing these diseases and who would likely benefit the most from the omega-3 therapy should it prove to be effective.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Both women and men
- •Age: > or = 18 years
- •Ethnicity and race: All ethnic and racial backgrounds welcome
- •As defined in ATP III of the National Cholesterol Education program, the metabolic syndrome will be diagnosed as presence of at least three of the following, which will be measured at the screening clinic visit:
- •Central obesity as measured by waist circumference:
- •Men: Greater than 40 inches
- •Women: Greater than 35 inches
- •Fasting blood triglycerides greater than or equal to 150 mg/dL
- •Blood HDL cholesterol:
- •Men: Less than 40 mg/dL
- •Women: Less than 50 mg/dL
- •Blood pressure greater than or equal to 130/85 mmHg
- •Fasting glucose greater than or equal to 100 mg/dL
- •Planning to be available for clinic visits and bottle pick-ups for the 8 weeks of study participation
- •Ability and willingness to give written informed consent
- •No known active psychiatric illness.
排除标准
- •Daily intake of dietary supplements containing omega-3 FAs within the past month.
- •Fasting blood glucose > 140 mg/dL
- •Significant liver enzyme abnormality
- •AST or ALT more than 2 times the upper limit of normal and/or
- •Bilirubin more than 50% the upper limit of normal
- •Renal disease as measured at baseline:
- •Serum creatinine > 1.30 mg/dL, or
- •Calculated creatinine clearance < 71 mL/min
- •Self reported personal history of:
- •Clotting disorders
- •Clinically significant atherosclerosis (e.g., CAD, PAD)
- •Malignant neoplasm
- •Ongoing infection
- •Inflammatory disease (e.g., rheumatoid arthritis)
- •Subjects currently receiving the following medications (self report):
- •Anti-Inflammatory drugs
- •Lipid lowering drugs including statins
- •Anti-hypertensive drugs
- •Anti-coagulant drugs
- •Body Mass Index (BMI) greater than or equal to
- •Pregnant or Lactating
- •Inability to communicate effectively with study personnel
结局指标
主要结局
Change from baseline in inflammatory markers (MCP-1, IL-6, and sICAM-1) at 8 weeks.
时间窗: Baseline and 8 weeks
Change was calculated as the value at 8 weeks minus the value at baseline
次要结局
- Change from baseline in low-density lipoprotein (LDL) cholesterol at 8 weeks.(Baseline and 8 weeks)
- Change from baseline in high-density lipoprotein (HDL) cholesterol at 8 weeks.(Baseline and 8 weeks)
- Change from baseline in red blood cells (RBC) Fatty Acids at 8 weeks.(Baseline and 8 weeks)
- Change from baseline in triglycerides at 8 weeks.(Baseline and 8 weeks)
研究者
Christopher Gardner
Professor of Medicine (Research)
Stanford University