Efficacy of Consumption of High-oleic Canola and Flaxseed Oils in the Management of Hypercholesterolemia and Other Cardiovascular Risk Factors
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Serum Lipids
研究概览
简要总结
The purpose of this study is to assess the efficacy of high-oleic canola oil and a high-oleic canola/flaxseed oil blend as compared to a typical Western diet on plasma lipids, fatty acid profiles, and risk factors associated with cardiovascular disease in hypercholesterolemic patients. Furthermore, the metabolism of dietary oleic acid and alpha-linolenic acid contained in high-oleic canola oil and flaxseed oil will be investigated.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fasting serum LDL-Cholesterol >3.0 mmol/L
- •Body mass index (BMI) between 22-36 kg/m2
排除标准
- •use of lipid lowering therapy
- •documented cardiovascular/atherosclerotic disease
- •inflammatory disease
- •uncontrolled hypertension
- •kidney disease
- •other systemic diseases
- •chronic alcohol consumption (> 2 servings/day)
- •excessive exercise expenditure (> 4000 kcal/week)
研究组 & 干预措施
High-Oleic Canola Oil
干预措施: High-Oleic Canola Oil (Dietary Supplement)
High-Oleic Canola/Flaxseed Oil Blend
干预措施: High-Oleic Canola/Flaxseed Oil Blend (Dietary Supplement)
Western Diet
干预措施: Western Dietary Control (Dietary Supplement)
结局指标
主要结局
Serum Lipids
时间窗: Baseline (Day 1,2) and Endpoint (Day 28,29) of each experimental phase
Inflammatory Biomarkers: C-Reactive Protein, Interleukin-6, sE-Selectin, sVCAM-1, sICAM-1
时间窗: Study Baseline (Day 1,2) and Endpoint (Day 28,29) of each experimental phase
Intima-Medial Thickness by Carotid Ultrasound
时间窗: Study Baseline (during Day 1-3) and Endpoint (during Day 24-26) of each experimental phase
Energy Expenditure by Indirect Calorimetry
时间窗: Study Baseline (during Week 1) and Endpoint (during Week 4) of each experimental phase
Body Composition by Dual Emission X-Ray Absorptiometry (DEXA)
时间窗: Baseline (Day1,2) and Endpoint (Day 28,29) of each experimental phase
Oxidation and Conversion of U-13C-Alpha Linolenic Acid
时间窗: Day 27 (time 0-8 hrs), Day 28 (24 hrs), Day 29 (48 hrs) of each experimental phase
Plasma Fatty Acid Concentrations
时间窗: Baseline (Day 1,2) and Endpoint (Day 28,29) of each experimental phase
次要结局
- Arterial Stiffness Index by Pulse Wave Analysis(Baseline (Day 1,2) and Endpoint (Day 28,29) of each experimental phase)