Clinical trial NCT03967678: Omega (n)-3 PUFA Enriched Beef & Health Outcomes.
Official title: Omega (n)-3 PUFA Enriched Beef to Improve Circulating Lipid Concentrations and CVD Risk Markers in Adults: a Randomised Controlled Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: CVD
Cholesterol; Metabolic Disorder
Inflammation
Keywords: enriched beef
omega
poly unsaturated fatty acids (PUFA)
cholesterol
grass fed
Lead sponsor: University of Ulster
Sponsor class: OTHER
Collaborators: name: Dunbia, Northern Ireland
First posted: 2019-05-30
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blind randomised controlled trial
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Cholesterol levels
timeFrame: Change at 5 weeks from baseline
Secondary outcomes:
measure: Lipid profile
timeFrame: Change at 5 weeks from baseline
measure: Polyunsaturated fatty acid profile
timeFrame: Change at 5 weeks from baseline
measure: Pulse Wave Velocity
timeFrame: Change at 5 weeks from baseline
measure: Blood pressure
timeFrame: Change at 5 weeks from baseline
measure: Whole body composition
timeFrame: Change at 5 weeks from baseline
measure: Inflammation status
timeFrame: Change at 5 weeks from baseline
Other outcomes:
Locations:
city: Coleraine
country: United Kingdom
facility: Human Intervention Studies Unit, Ulster University
state: Co.Londonderry
Study officials:
References: