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

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03967678
• Other study ID #: 18/WS/0149
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Cholesterol; Metabolic Disorder
• CVD
• Inflammation
• Metabolic Diseases

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