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临床试验/NCT04120220
NCT04120220终止不适用

Shake It Up: Lipidomics of Lipoproteins and Diet

USDA Grand Forks Human Nutrition Research Center2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2019年11月12日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
11
试验地点
2
主要终点
Change in lipidomic composition of plasma post-prandial lipoproteins as assessed by incremental area under the curve (iAUC)

研究概览

简要总结

The purpose of this research is to understand how dietary fat is related to cardiovascular disease (CVD). This study tests the effect of different dietary fats on the level of fat in the blood and the particles that transport fat in the blood. The researchers want to know if these particles change after eating meals made with different fats.

详细描述

The overall objective of this work is to discover how the lipidomic composition of postprandial lipoproteins responds to dietary fats of differing fatty acid composition by comparing meals rich in saturated fatty acid (SFA) (from dairy cream) versus polyunsaturated fatty acids (PUFA) (from soybean oil). The information derived from these studies will provide mechanistic insight into postprandial lipid metabolism and will support efforts to identify optimal dietary oil intakes for people.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Normal to overweight (BMI 18.0-29.9 kg/m^2
  • Willing to comply with the demands of the experimental protocol

排除标准

  • Inability to provide consent
  • Have fasting blood glucose <60 mg/dL or >126 mg/dL
  • Have fasting blood cholesterol >300 mg/dL
  • Have fasting blood triglyceride <100 mg/dL or >300 mg/dL
  • Have uncontrolled hypertension (blood pressure >140/90 mm Hg)
  • Take prescription medications for blood sugar or lipid management or anti-inflammatory steroids (e.g. cortisone)
  • Over the counter use of supplements (fish oil, flax, plant sterol or sterol esters) and unwilling to discontinue use for 6 weeks prior to study initiation
  • Have a history of an eating disorder, unusual dietary pattern (extreme nutrient or food group restriction; erratic meals due to shift work, etc.)
  • Have established cardiovascular, pulmonary, and/or a metabolic disease such as diabetes
  • Have cancer
  • Use tobacco products or nicotine in any form including snuff, pills, and patches, or e-cigarettes/vaping in the past 6 weeks
  • Have alcohol, anabolic steroids, or other substance abuse issues
  • Consume more than 3 alcoholic drinks/week
  • Are lactose intolerant or have an allergy to dairy foods

结局指标

主要结局

Change in lipidomic composition of plasma post-prandial lipoproteins as assessed by incremental area under the curve (iAUC)

时间窗: 0, 1, 2, 4, 6, 8 hours post meal intake

次要结局

未报告次要终点

研究者

发起方
USDA Grand Forks Human Nutrition Research Center
申办方类型
Fed
责任方
Sponsor

研究点 (2)

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