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

NCT ID: NCT03967678

Last Updated: 2019-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-07
• Study Completion Date: 2019-04-19

Brief 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.

Conditions

CVD; Cholesterol; Metabolic Disorder; Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Beef from standard supply

Group Type: PLACEBO_COMPARATOR

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

Intervention Type: DIETARY_SUPPLEMENT

Lunches served in Human Intervention Studies Unit

n-3 enriched beef from dietary supplement finished cattle

Group Type: EXPERIMENTAL

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

Intervention Type: DIETARY_SUPPLEMENT

Lunches served in Human Intervention Studies Unit

n-3 enriched beef from grass finished cattle

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DIETARY_SUPPLEMENT

Lunches served in Human Intervention Studies Unit

Interventions

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

Lunches served in Human Intervention Studies Unit

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dunbia, Northern Ireland

UNKNOWN

Sponsor Role: collaborator

University of Ulster

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Human Intervention Studies Unit, Ulster University

Coleraine, Co.Londonderry, United Kingdom

Countries

United Kingdom

Other Identifiers

18/WS/0149

Identifier Type: -

Identifier Source: org_study_id