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临床试验/NCT02337231
NCT02337231已完成不适用

Role of Fatty Acid Desaturase(s) (FADS) Polymorphisms in Determining the In Vivo Metabolism of Polyunsaturated Fatty Acids (PUFAs) in Botanical Oils in Humans.

Wake Forest University Health Sciences2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2014年6月24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
66
试验地点
2
主要终点
Change in serum fatty acids from baseline as measured in mass and recorded as mg/dL

研究概览

简要总结

A randomized, controlled, cross-over clinical trial of borage oil vs soybean oil to determine whether the metabolism and/or impact of medium chain-polyunsaturated fatty acids (MC-PUFAs) in botanical oil supplements are changed in relationship to specific genotypes in a SNP (rs174537) strongly associated with FADS1 activity and PUFA metabolism.

详细描述

The study will be a randomized, controlled, cross-over clinical trial of borage oil and soybean oil to determine whether the metabolism and/or impact of MC-PUFAs in botanical oil supplements are changed in relationship to specific genotypes in a SNP (rs174537) strongly associated with FADS1 activity and PUFA metabolism. Subjects previously genotyped at rs174537 will be given supplements and both blood PUFA (serum and erythrocyte membranes), urinary eicosanoids and eicosanoid release from whole blood (leukocyte generation) will be measured as biochemical determinants of genotype impact on supplement metabolism.

To evaluate the effect of genotype at the rs174537 locus on the metabolism of MC-PUFAs in borage and soybean oil to long chain polyunsaturated fatty acids (LC-PUFAs), including arachidonic acid, the investigators will utilize a double blind, randomized, crossover design. There will be three study groups based on the genotype of the healthy volunteer at rs174537. Individuals within each genotype will be consented and screened up to 8 weeks prior to randomization and the start of the intervention. Subjects will be randomized to begin with 4 weeks of either borage oil or soybean oil followed by an 8 week washout period, and then another 4 week period in which they take the second oil. Study visits will occur at 0, 2, and 4 weeks during each oil supplementation period, in addition to the consenting visit, for a total of 7 visits during the study.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
21 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Able to give informed consent
  • Must agree to adhere to dietary requirements during the entire study
  • Be willing to participate for the whole study
  • Be willing to not take PUFA supplements outside of those provided by the study
  • Agree not to take interfering medications during the duration of the study
  • Agree to allow samples to be stored for future use

排除标准

  • May not have diabetes, cancer, heart attack or vascular surgery within the past year, be diagnosed with heart disease, have uncontrolled high blood pressure, history of stroke, atherosclerosis, asthma, multiple sclerosis or chronic joint disease
  • Gallbladder removal or gallbladder disease
  • Use of tobacco products within the last six months
  • Pregnancy or lactation
  • Fasting triglycerides greater than 150 mg/dl
  • Blood pressure greater than 130/90
  • BMI equal to or greater than 30 or less than 19
  • Fasting glucose greater than 125 mg/dl
  • Have liver function values in the normal range
  • Taking greater than 100 mg aspirin/day
  • Taking NSAIDS or oral corticosteroids
  • Taking montelukast-type allergy medications
  • Having a pacemaker or a defibrillator
  • Taking lipid lowering medications

研究组 & 干预措施

GG genotype

Other

Healthy participants with genotype GG at rs174537 will take gel capsules that contain soybean oil (4-weeks) and borage oil (4-weeks) in a crossover study.

干预措施: soybean oil and borage oil (Dietary Supplement)

GT genotype

Other

Healthy participants with genotype GT at rs174537 will take gel capsules that contain soybean oil (4-weeks) and borage oil (4-weeks) in a crossover study.

干预措施: soybean oil and borage oil (Dietary Supplement)

TT genotype

Other

Healthy participants with genotype TT at rs174537 will take gel capsules that contain soybean oil (4-weeks) and borage oil (4-weeks) in a crossover study.

干预措施: soybean oil and borage oil (Dietary Supplement)

结局指标

主要结局

Change in serum fatty acids from baseline as measured in mass and recorded as mg/dL

时间窗: 16-week study

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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