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

NCT03967678 | Completed

• 1 other identifier: 18/WS/0149
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Keywords

enriched beef; omega; poly unsaturated fatty acids (PUFA); cholesterol; grass fed

Outcome Measures

Primary Outcomes (1)

• Cholesterol levels

  Plasma cholesterol measured colormetrically

  Change at 5 weeks from baseline

Secondary Outcomes (6)

• Lipid profile

  Change at 5 weeks from baseline

• Polyunsaturated fatty acid profile

  Change at 5 weeks from baseline

• Pulse Wave Velocity

  Change at 5 weeks from baseline

• Blood pressure

  Change at 5 weeks from baseline

• Whole body composition

  Change at 5 weeks from baseline

Study Arms (3)

Beef from standard supply

PLACEBO COMPARATOR

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

n-3 enriched beef from dietary supplement finished cattle

EXPERIMENTAL

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

n-3 enriched beef from grass finished cattle

ACTIVE COMPARATOR

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

Interventions

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

Lunches served in Human Intervention Studies Unit

Beef from standard supply; n-3 enriched beef from dietary supplement finished cattle; n-3 enriched beef from grass finished cattle

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Ulster: lead
• Dunbia, Northern Ireland: collaborator

Study Sites (1)

Human Intervention Studies Unit, Ulster University

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

Location

MeSH Terms

Conditions

Metabolic Diseases; Inflammation

Interventions

Red Meat; WW Domain-Containing Oxidoreductase

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Meat; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Short Chain Dehydrogenase-Reductases; NAD (+) and NADP (+) Dependent Alcohol Oxidoreductases; Alcohol Oxidoreductases; Oxidoreductases; Enzymes; Enzymes and Coenzymes; Tumor Suppressor Proteins; Neoplasm Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double blind randomised controlled trial

Study Record Dates

• First Submitted: May 27, 2019
• First Posted: May 30, 2019
• Study Start: November 7, 2018
• Primary Completion: April 19, 2019
• Study Completion: April 19, 2019
• Last Updated: June 3, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)