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临床试验/NCT01564498
NCT01564498Unknown1 期

A Pilot Study of the Effects of Replacing Orange Carrots and White Potatoes With Purple Varieties, on Risk Factors for Cardiovascular Disease

University of Guelph1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2012年4月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
入组人数
60
试验地点
1
主要终点
Blood cholesterol

研究概览

简要总结

The hypothesis is that richly coloured purple vegetables, rich in polyphenolic compounds including anthocyanins will have higher antioxidant and other biological activities, than more lightly coloured versions of these foods. Diets of human subjects will be modified to allow consumption of 200-300 g of raw carrots or cooked potatoes. Participants will be randomized to consume either orange or purple carrots, or white or purple potatoes. They will consume these diets for 12 weeks and bioavailability of polyphenolics will be examined as well as anthropometry and blood biochemistry for changes in risk factors associated with cardiovascular disease.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

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

  • •adult men and women 18-65 years of age
  • •must have a least one of the following risk factors associated with increased risk of type II diabetes and/or cardiovascular disease:
  • •borderline high or hypertension or undergoing treatment for such
  • •abnormal fasting blood glucose or undergoing treatment for such
  • •overweight or obese
  • •borderline high or high LDL-cholesterol or undergoing treatment for such
  • •borderline low or low HDL-cholesterol
  • •borderline high or high triglycerides or undergoing treatment for such

排除标准

  • •smokers, pregnant or nursing women

研究组 & 干预措施

White potato

Placebo Comparator

Participants will consume 300-500 g of cooked white potatoes per day

干预措施: vegetable (Other)

Purple Potato

Experimental

Participants will consume 300-500 g of cooked purple potato per day

干预措施: vegetable (Other)

Orange carrots

Placebo Comparator

Participants will consume 200-300 g typical varieties of orange carrots during the intervention

干预措施: vegetable (Other)

Purple Carrots

Experimental

Participants will consume 200-300 g raw purple carrots instead of orange carrots in the control arm

干预措施: vegetable (Other)

结局指标

主要结局

Blood cholesterol

时间窗: 12 weeks

blood will be collected at baseline before the experimental foods are introduced and again 6 weeks into the intervention period and during the last week of the intervention (week 12)

次要结局

  • blood pressure(12 weeks)
  • body composition(12 weeks)
  • insulin resistance(12 weeks)
  • blood and urinary polyphenol metabolites(12 weeks)
  • circulating biomarkers of cardiovascular disease and type II diabetes risk(12 weeks)

研究者

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

Kelly Anne Meckling, PhD

Professor

University of Guelph

研究点 (1)

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