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临床试验/NCT03291548
NCT03291548已完成不适用

Effect of a Quinoa-enriched Biscuit as Novel Food Product to Improve CVD Risk Markers in Older Adults: a Randomised Crossover Study

University of Ulster2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年2月13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
40
试验地点
2
主要终点
Total cholesterol

研究概览

简要总结

Cardiovascular disease (CVD) is one of the most common chronic diseases in older populations, which has been increasing in line with rising overweight and obesity levels in recent years. Dietary intake is a major modifiable risk factor for CVD, and one such recommendation is to increase the intake of essential (omega-3) polyunsaturated fats in our diets, for example by consuming more oily fish. We know, however, from large population level dietary surveys, that many individuals within the United Kingdom (UK) population are not consuming enough oily fish. Therefore, alternative dietary sources of omega-3 polyunsaturated fats are required to help meet consumer needs.

Quinoa is a traditional Andean seed crop consumed in a similar fashion to staple cereal grains in Europe, and the popularity of quinoa has been growing worldwide because of its nutritional content and perceived healthiness. Quinoa contains a small amount of fat, but the ratio of omega-6 and omega-3 essential fats is more favourable in quinoa than in other plant oils. An opportunity therefore exists to incorporate quinoa flour into more frequently consumed food products (e.g. biscuits) as an alternative means of increasing consumers omega-3 intake.

The purpose of this study is to investigate the effect of consuming quinoa-enriched biscuits, compared to control, on markers of CVD risk over 4-weeks in older adults.

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
Double (Participant, Investigator)

盲法说明

Double Blind: researcher and particiapant unaware of the intervention assignment

入排标准

年龄范围
50 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Free-living, apparently healthy adults
  • Aged 50-75 years at recruitment
  • Low fish consumers (<2 servings/wk)
  • Non-smokers
  • Not regularly consuming plant stanols

排除标准

  • Non-free-living adults
  • Aged <50 or >75 years at recruitment
  • Fish consumers (2 servings/wk or more)
  • Current smokers
  • Pregnant/lactating females
  • Coeliac disease, wheat intolerance or any other food allergy or intolerance that would prevent consumption of the biscuits
  • Currently taking any fish oil-containing supplement
  • Diagnosed with a chronic medical condition (such as diabetes; CVD autoimmune/ inflammatory disorders; cancer)
  • Prescribed cholesterol or blood pressure lowering medications
  • Daily consumption of plant stanols

研究组 & 干预措施

Quinoa Biscuit

Experimental

The quinoa-enriched biscuits containing 7.11g quinoa flour.

干预措施: Quinoa biscuit (Dietary Supplement)

Control biscuit

Placebo Comparator

The placebo control biscuit: an iso-energetic, matched product in terms of appearance, taste, texture and smell.

干预措施: Control biscuit (Dietary Supplement)

结局指标

主要结局

Total cholesterol

时间窗: Change from baseline compared to control arm

Plasma cholesterol

次要结局

  • LDL-cholesterol(Change from baseline compared to control arm)
  • Poly-unsaturated fatty acid status(Change from baseline compared to control arm)
  • Triglycerides(Change from baseline compared to control arm)
  • total/HDL-cholesterol ratio(Change from baseline compared to control arm)
  • Blood pressure(Change from baseline compared to control arm)
  • Inflammatory status(Change from baseline compared to control arm)
  • Weight(Change from baseline compared to control arm)
  • HDL-cholesterol(Change from baseline compared to control arm)
  • Antioxidant status(Change from baseline compared to control arm)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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