Inflammation Clinical Trial
Official title:
Omega (n)-3 PUFA Enriched Beef to Improve Circulating Lipid Concentrations and CVD Risk Markers in Adults: a Randomised Controlled Study.
Verified date | May 2019 |
Source | University of Ulster |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 90 |
Est. completion date | April 19, 2019 |
Est. primary completion date | April 19, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Human Intervention Studies Unit, Ulster University | Coleraine | Co.Londonderry |
Lead Sponsor | Collaborator |
---|---|
University of Ulster | Dunbia, Northern Ireland |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cholesterol levels | Plasma cholesterol measured colormetrically | Change at 5 weeks from baseline | |
Secondary | Lipid profile | Plasma lipids measured colormetrically | Change at 5 weeks from baseline | |
Secondary | Polyunsaturated fatty acid profile | Serum fatty acids measured by GC-MS | Change at 5 weeks from baseline | |
Secondary | Pulse Wave Velocity | Measured by Sphygmocor XCEL | Change at 5 weeks from baseline | |
Secondary | Blood pressure | Measured by electronic blood pressure monitor | Change at 5 weeks from baseline | |
Secondary | Whole body composition | Measured by Dual Energy X-ray Absorptiometry | Change at 5 weeks from baseline | |
Secondary | Inflammation status | Measured by ELISA | Change at 5 weeks from baseline |
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