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

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

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.

Study Overview

• Status: Completed
• Conditions: Inflammation; Cholesterol; Metabolic Disorder; CVD
• Intervention / Treatment: Dietary supplement: Three portions per week (690g beef (raw weight)) for 5 weeks

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Co.Londonderry
    • Coleraine, Co.Londonderry, United Kingdom, BT52 1SA
      • Human Intervention Studies Unit, Ulster University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Beef from standard supply	Dietary supplement: Three portions per week (690g beef (raw weight)) for 5 weeks; Lunches served in Human Intervention Studies Unit
EXPERIMENTAL: n-3 enriched beef from dietary supplement finished cattle	Dietary supplement: Three portions per week (690g beef (raw weight)) for 5 weeks; Lunches served in Human Intervention Studies Unit
ACTIVE_COMPARATOR: n-3 enriched beef from grass finished cattle	Dietary supplement: Three portions per week (690g beef (raw weight)) for 5 weeks; Lunches served in Human Intervention Studies Unit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cholesterol levels	Plasma cholesterol measured colormetrically	Change at 5 weeks from baseline

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Ulster
• Collaborators: Dunbia, Northern Ireland

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 7, 2018
• Primary Completion (ACTUAL): April 19, 2019
• Study Completion (ACTUAL): April 19, 2019

Study Registration Dates

• First Submitted: May 27, 2019
• First Submitted That Met QC Criteria: May 27, 2019
• First Posted (ACTUAL): May 30, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 3, 2019
• Last Update Submitted That Met QC Criteria: May 30, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: cholesterol; enriched beef; omega; poly unsaturated fatty acids (PUFA); grass fed
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Metabolic Diseases
• Other Study ID Numbers: 18/WS/0149

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No