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临床试验/NCT02469285
NCT02469285已完成不适用

The Effect of Pork With Modified Fatty Acid Composition on Plasma Lipids and Fatty Acids and the Effect of Pork and Berries on Fecal Compounds in Healthy Adults

University of Helsinki2 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2014年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
65
试验地点
2
主要终点
Change in plasma fatty acids as a measure of dietary fatty acid modification

研究概览

简要总结

High consumption of red meat is related to cardiovascular diseases. Red meat containing more unsaturated fat than normal red meat may have a beneficial impact on plasma lipid and fatty acid profile in humans. Furthermore, consumption of red meat and especially processed red meat is considered harmful to colon health. However, consumption of fruit and berries rich in antioxidants and flavonoids may provide protection when red meat is consumed.

The study aims to answer whether the fatty acid profile of pork when modified towards more unsaturated fat will affect plasma fatty acids and lipids in adult volunteers. The effects of pork with a modified fatty acid content is compared with conventional pork with lower unsaturated fat content. Fatty acid composition of pork is modified by altering the composition of animal feed.

The other arm of the study investigates the effects of consuming berries together with red meat on gut metabolism. The study focuses on how berries affect the formation of fecal compounds known to be related to high red meat consumption, such as N-nitroso compounds.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 68 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • diet includes meat

排除标准

  • high consumption of fish (4 times per week)
  • use of fish oil/ omega-3 oil capsules one month before the intervention
  • hypercholesterolemia
  • vegetarian, vegan

结局指标

主要结局

Change in plasma fatty acids as a measure of dietary fatty acid modification

时间窗: 4 weeks

Change in fecal nitroso compounds as a measure of increased (processed) red meat consumption

时间窗: 4 weeks

Measured as apparent total nitroso compounds (ATNC)

Genotoxicity testing of human fecal water in 3D cell culture

时间窗: 4 weeks

Fecal water is isolated from fecal samples collected before and after the intervention period from arms B and C. The samples are tested for markers of genotoxicity in 3D cell culture.

次要结局

  • Change in hemoglobin as a measure of dietary modification(4 weeks)
  • Concentration of polyphenolics in fecal water as a measure of consumption of berries(4 weeks)
  • Changes in plasma lipids as a measure of dietary modification(4 weeks)
  • Change in blood pressure as a measure of dietary modofcation(4 weeks)
  • Weight development during the study period(4 weeks)

研究者

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

Anne-Maria Pajari

Adjunct professor

University of Helsinki

研究点 (2)

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