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临床试验/NCT03967678
NCT03967678已完成不适用

Omega (n)-3 PUFA Enriched Beef to Improve Circulating Lipid Concentrations and CVD Risk Markers in Adults: a Randomised Controlled Study.

University of Ulster2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2018年11月7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
90
试验地点
2
主要终点
Cholesterol levels

研究概览

简要总结

Red meat is an integral component of the habitual diet among the UK and Irish population, with adults consuming an average of 71grams/day. Although typically high in saturated fatty acids (SFA), red meat is also an important dietary source of protein and essential nutrients including iron, zinc, B vitamins and long chain n-3 polyunsaturated fatty acids (PUFA) which provide numerous benefits to human health, particularly related to cardiovascular disease (CVD) risk. N-3 and n-6 PUFA are a family of fatty acids with important roles in cardiovascular health, and it is often recommended in dietary guidelines to replace SFA with unsaturated fats, such as PUFA. Owing to the social and economic burden of CVD, increasing the proportions of these unsaturated fatty acids, in combination with a reduction in SFA within meat, could have a large impact on CVD risk at the population level, whilst retaining the beneficial nutrients and n-3 PUFA which meat provides.

In this research, a total of 90 eligible and consenting participants will be randomly allocated to consume three portions per week of n-3 enriched beef (from either dietary supplemented or grass-fed cattle) or control beef (from standard supply). This beef will be offered within a lunchtime meal and served from the Human Intervention Studies Unit at Ulster University, Coleraine for a period of 5 weeks. A fasting blood sample will be taken before and after intervention to determine the effect the n-3 enriched beef on cholesterol concentrations, lipid profile, PUFA status and inflammation. Blood pressure, stiffness of the arteries and body shape, size and composition will also be assessed, and some health and lifestyle habits will be captured using questionnaires.

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
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Double blind

入排标准

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

入选标准

  • Free-living, apparently healthy adults
  • Aged 20+ years at recruitment
  • Low oily fish consumers (<2 servings/mo), or those willing to reduce their fish consumption 1 month prior to commencing the study
  • Non-smokers
  • Not regularly consuming plant stanols or other n-3 enriched foodstuffs

排除标准

  • Non-free-living adults
  • Adults <20 years at recruitment
  • Oily fish consumers (2 servings/mo or more)
  • Current smokers
  • Pregnant/lactating females (or planning to become pregnant)
  • Food allergy or intolerance that would prevent consumption of the study meals
  • Diagnosed with a chronic medical condition (such as diabetes; CVD; autoimmune/ inflammatory disorders; cancer)
  • Prescribed cholesterol or blood pressure lowering medications
  • Currently taking any fish oil-containing supplement Daily consumption of plant stanols or other n-3 enriched foodstuffs

研究组 & 干预措施

n-3 enriched beef from grass finished cattle

Active Comparator

干预措施: Three portions per week (690g beef (raw weight)) for 5 weeks (Dietary Supplement)

Beef from standard supply

Placebo Comparator

干预措施: Three portions per week (690g beef (raw weight)) for 5 weeks (Dietary Supplement)

n-3 enriched beef from dietary supplement finished cattle

Experimental

干预措施: Three portions per week (690g beef (raw weight)) for 5 weeks (Dietary Supplement)

结局指标

主要结局

Cholesterol levels

时间窗: Change at 5 weeks from baseline

Plasma cholesterol measured colormetrically

次要结局

  • Whole body composition(Change at 5 weeks from baseline)
  • Lipid profile(Change at 5 weeks from baseline)
  • Blood pressure(Change at 5 weeks from baseline)
  • Polyunsaturated fatty acid profile(Change at 5 weeks from baseline)
  • Pulse Wave Velocity(Change at 5 weeks from baseline)
  • Inflammation status(Change at 5 weeks from baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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