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

Study Overview
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Brief Summary
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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.

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

Conditions
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CVD, Cholesterol; Metabolic Disorder, Inflammation

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double blind randomised controlled trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Beef from standard supply<br> | Dietary Supplement: Three portions per week (690g beef (raw weight)) for 5 weeks<br>* Lunches served in Human Intervention Studies Unit<br>|
| Experimental: n-3 enriched beef from dietary supplement finished cattle<br> | Dietary Supplement: Three portions per week (690g beef (raw weight)) for 5 weeks<br>* Lunches served in Human Intervention Studies Unit<br>|
| Active Comparator: n-3 enriched beef from grass finished cattle<br> | Dietary Supplement: Three portions per week (690g beef (raw weight)) for 5 weeks<br>* Lunches served in Human Intervention Studies Unit<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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enriched beef, omega, poly unsaturated fatty acids (PUFA), cholesterol, grass fed