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Completed

NCT Number: NCT03967678

Omega (n)-3 PUFA Enriched Beef & Health Outcomes.

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Human Intervention Studies Unit, Ulster University

Coleraine, Co.Londonderry, BT52 1SA, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Three portions per week (690g beef (raw weight)) for 5 weeks

Dietary Supplement

Lunches served in Human Intervention Studies Unit

Primary outcomes

  1. Cholesterol levels

    Time frame: Change at 5 weeks from baseline

    Plasma cholesterol measured colormetrically

Secondary outcomes

  1. Lipid profile

    Time frame: Change at 5 weeks from baseline

    Plasma lipids measured colormetrically

  2. Polyunsaturated fatty acid profile

    Time frame: Change at 5 weeks from baseline

    Serum fatty acids measured by GC-MS

  3. Pulse Wave Velocity

    Time frame: Change at 5 weeks from baseline

    Measured by Sphygmocor XCEL

  4. Blood pressure

    Time frame: Change at 5 weeks from baseline

    Measured by electronic blood pressure monitor

  5. Whole body composition

    Time frame: Change at 5 weeks from baseline

    Measured by Dual Energy X-ray Absorptiometry

  6. Inflammation status

    Time frame: Change at 5 weeks from baseline

    Measured by ELISA

Sponsors and collaborators

Lead sponsor

University of Ulster

Other

Collaborators

  • Dunbia, Northern Ireland

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 30, 2019
Registry last updated
Jun 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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