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临床试验/NCT01351012
NCT01351012已完成不适用

Canola and Flax Oils in Modulation of Vascular Function and Biomarkers of Cardiovascular Disease Risk

University of Manitoba1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2010年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
140
试验地点
1
主要终点
Change in endothelial function

研究概览

简要总结

The purpose of the study is to examine how the consumption of different dietary oil varieties affects a broad range of metabolic responses that are important in the development of cardiovascular diseases. This study will examine the relationship between dietary oil consumption and arterial function, blood fat content, and blood markers of cardiovascular disease risk. Additionally, the efficiency of the body in converting fat from dietary oils into other specific fat compounds with know health benefits will be examined. Also, the correlation between psychosocial parameters and vascular function will be studied.

详细描述

Although consumption of omega-3 fatty acids favorably modulate circulating lipids and arterial health, there is confusion surrounding the specific health benefits of plant based alpha-linolenic acid (ALA) versus marine derived eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). This research will examine the health benefits of ALA from consumption of diets rich in canola oil, novel monounsaturated fatty acid (MUFA) and DHA enriched canola oils, and flax oil compared with a control diet representative of North American diets rich in omega-6 and saturated fats. Treatment oils will be examined for potential influence on endothelial dysfunction, inflammation, oxidation, body composition, and plasma lipoprotein characterization. Furthermore, in an effort to elucidate the genetic factors that promote ALA conversion to EPA/DHA and strengthen the role of ALA in cardiovascular health, a major objective is to correlate common genetic variants in the fatty acid desaturase 1 (FADS1) and fatty acid desaturase 2 (FADS2) gene cluster with ALA conversion to EPA/DHA and n-3 fatty acid composition of serum phospholipids in response to consumption of the treatment oils. Besides, psychosocial predictors of vascular function 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
Triple (Participant, Investigator, Outcomes Assessor)

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

  • •Waist circumference ≥94 cm (males) or ≥80 cm (females)
  • •plus at least one of the following:
  • •Triglycerides ≥1.7 mmol/L
  • •High density lipoprotein (HDL) cholesterol <1 mmol/L (males) or <1.3 mmol/L (females)
  • •Low density lipoprotein (LDL) cholesterol ≥3.5 mmol/L
  • •Blood pressure ≥130 mmHg (systolic) and/or ≥85 mmHg (diastolic)
  • •Glucose ≥5.5 mmol/L

排除标准

  • •Thyroid disease
  • •Diabetes mellitus
  • •Kidney disease
  • •Liver disease
  • •Heavy drinking
  • •Use of medication known to affect lipid metabolism during the last 3 months(cholestyramine, colestipol, niacin, clofibrate, gemfibrozil, probucol, HMG CoA reductase inhibitors)

研究组 & 干预措施

Flax and safflower oil

Active Comparator

干预措施: Flax and safflower oil (Other)

Corn and safflower oil

Placebo Comparator

干预措施: Corn and safflower oil (Other)

Canola oil

Active Comparator

干预措施: Canola oil (Other)

High oleic acid canola oil

Active Comparator

干预措施: High oleic acid canola oil (Other)

DHA enriched high oleic acid canola oil

Active Comparator

干预措施: DHA enriched high oleic acid canola oil (Other)

结局指标

主要结局

Change in endothelial function

时间窗: Endothelial function will be measured at baseline and at the end of each of the five 4-week treatment phases over a period of nine months.

Non-invasive peripheral arterial tonometry (EndoPAT) is used to assess endothelial function.

次要结局

  • Change in body composition(Measurements will be done at the start and end of each of the five 4-week treatment phases over a period of nine months.)
  • Change in FADS 1 & 2 mRNA and protein expression(Blood samples will be collected at the end of each of the five 4-week treatment phases over a nine-month period.)
  • Change in ALA conversion to EPA/DHA(Blood samples will be collected at the end of each of the five 4-week treatment phases over a period of nine months.)
  • Change in psychosocial correlates(Measurements are done at baseline, at the start of the fifth treatment phase and at the end of each of the five 4-week treatment phases.)
  • Change in plasma lipids and lipoproteins, inflammatory cytokines and peroxidation biomarkers(Blood samples are collected at the start and end of each of the five 4-week treatment phases over a nine-month period.)
  • Blood Pressure(Over 3 years; at baseline and endpoint of each 4-week treatment phases)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Peter Jones

Director of the Richardson Centre for Functional Foods and Nutraceuticals

University of Manitoba

研究点 (1)

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