NCT03054779已完成不适用
Canola Oil Multi-center Intervention Trial II (COMIT II): Effects of Oleic Acid Enriched and Regular Canola Oil on Body Composition and Lipid Metabolism in Participants With Metabolic Syndrome Risk Factors
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Inflammatory markers
研究概览
简要总结
Building on the findings from the investigators previous study, COMIT I, the purpose of the COMIT II study is to supplement the DEXA measurement of body composition with a supplementary DEXA measurement of visceral adipose tissue and to specifically target the impact of oleic acid consumption on body composition as the primary objective. COMIT II also will include analysis of fatty acid ethanolamines (FAEs) and their precursors to elucidate the mechanisms by which canola oil may be modifying body composition, measurement of endothelial function, inflammatory, adiposity and insulin sensitivity biomarkers, and genetic analyses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •waist circumference ≥94 cm for men and ≥80 cm for women
- •Elevated triglycerides - ≥150 mg/dL and ≤ 400 mg/dL
- •Reduced HDL - < 40 mg/dL for men and < 50 mg/dL for women
- •Fasting glucose - ≥ 100 mg/dl and ≤ 126 mg/dL
- •Elevated blood pressure - systolic ≥130 and/or diastolic ≥85 mm HG [Unmedicated participants - upper limit of Stage 1 Hypertension: systolic < 160 and/or diastolic <100 mm HG and participants must be free of end stage/target organ disease symptoms] [BP medicated participants: acceptable as long as individuals meet the specified blood pressure range of <140/90 mmHg, and have been stable for at least 6 months]
排除标准
- •Individuals with thyroid**, kidney, or liver disease [Individuals with thyroid disease whose blood values are within normal limits and that have been stable (on medication) for the past 6 months are considered eligible]
- •Individuals with diabetes mellitus
- •Individuals consuming >14 alcoholic beverages per week
- •Individuals taking lipid lowering medication (ex: cholestyramine, colestipol, niacin, cloribrate, gemfibrozil, probucol, HMG CoA reductase inhibitors) for at least the last 3 months
- •Pregnancy or lactation
结局指标
主要结局
Inflammatory markers
时间窗: 1 year 6 months
Body composition
时间窗: 1 year 6 months
Will be measured using DXA
Plasma lipids
时间窗: 1 year 6 months
Lipid Peroxidation
时间窗: 1 year 6 months
Lipoprotein subclasses
时间窗: 1 year 6 months
Flow mediated dilation (FMD) for endothelial function
时间窗: 1 year 6 months
次要结局
- Genetic analysis to evaluate the association between FADS 1 and FADS 2 mRNA and protein expression in peripheral blood mononuclear blood cells (PBMCs)(1 year 6 months)
- Assessment of fatty acid inter-conversion and synthesis using stable isotope tracers(1 year 6 months)
- Physical activity level(1 year 6 months)
研究者
研究点 (2)
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