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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03967678
Other study ID # 18/WS/0149
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 7, 2018
Est. completion date April 19, 2019

Study information

Verified date May 2019
Source University of Ulster
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date April 19, 2019
Est. primary completion date April 19, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years and older
Eligibility 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

Study Design


Intervention

Dietary Supplement:
Three portions per week (690g beef (raw weight)) for 5 weeks
Lunches served in Human Intervention Studies Unit

Locations

Country Name City State
United Kingdom Human Intervention Studies Unit, Ulster University Coleraine Co.Londonderry

Sponsors (2)

Lead Sponsor Collaborator
University of Ulster Dunbia, Northern Ireland

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cholesterol levels Plasma cholesterol measured colormetrically Change at 5 weeks from baseline
Secondary Lipid profile Plasma lipids measured colormetrically Change at 5 weeks from baseline
Secondary Polyunsaturated fatty acid profile Serum fatty acids measured by GC-MS Change at 5 weeks from baseline
Secondary Pulse Wave Velocity Measured by Sphygmocor XCEL Change at 5 weeks from baseline
Secondary Blood pressure Measured by electronic blood pressure monitor Change at 5 weeks from baseline
Secondary Whole body composition Measured by Dual Energy X-ray Absorptiometry Change at 5 weeks from baseline
Secondary Inflammation status Measured by ELISA Change at 5 weeks from baseline
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