Omega (n)-3 PUFA Enriched Beef & Health Outcomes.
Primary Purpose
CVD, Cholesterol; Metabolic Disorder, Inflammation
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Three portions per week (690g beef (raw weight)) for 5 weeks
Sponsored by
About this trial
This is an interventional prevention trial for CVD focused on measuring enriched beef, omega, poly unsaturated fatty acids (PUFA), cholesterol, grass fed
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
Sites / Locations
- Human Intervention Studies Unit, Ulster University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Active Comparator
Arm Label
Beef from standard supply
n-3 enriched beef from dietary supplement finished cattle
n-3 enriched beef from grass finished cattle
Arm Description
Outcomes
Primary Outcome Measures
Cholesterol levels
Plasma cholesterol measured colormetrically
Secondary Outcome Measures
Lipid profile
Plasma lipids measured colormetrically
Polyunsaturated fatty acid profile
Serum fatty acids measured by GC-MS
Pulse Wave Velocity
Measured by Sphygmocor XCEL
Blood pressure
Measured by electronic blood pressure monitor
Whole body composition
Measured by Dual Energy X-ray Absorptiometry
Inflammation status
Measured by ELISA
Full Information
NCT ID
NCT03967678
First Posted
May 27, 2019
Last Updated
May 30, 2019
Sponsor
University of Ulster
Collaborators
Dunbia, Northern Ireland
1. Study Identification
Unique Protocol Identification Number
NCT03967678
Brief Title
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
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
November 7, 2018 (Actual)
Primary Completion Date
April 19, 2019 (Actual)
Study Completion Date
April 19, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Ulster
Collaborators
Dunbia, Northern Ireland
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CVD, Cholesterol; Metabolic Disorder, Inflammation
Keywords
enriched beef, omega, poly unsaturated fatty acids (PUFA), cholesterol, grass fed
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double blind randomised controlled trial
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Double blind
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Beef from standard supply
Arm Type
Placebo Comparator
Arm Title
n-3 enriched beef from dietary supplement finished cattle
Arm Type
Experimental
Arm Title
n-3 enriched beef from grass finished cattle
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Three portions per week (690g beef (raw weight)) for 5 weeks
Intervention Description
Lunches served in Human Intervention Studies Unit
Primary Outcome Measure Information:
Title
Cholesterol levels
Description
Plasma cholesterol measured colormetrically
Time Frame
Change at 5 weeks from baseline
Secondary Outcome Measure Information:
Title
Lipid profile
Description
Plasma lipids measured colormetrically
Time Frame
Change at 5 weeks from baseline
Title
Polyunsaturated fatty acid profile
Description
Serum fatty acids measured by GC-MS
Time Frame
Change at 5 weeks from baseline
Title
Pulse Wave Velocity
Description
Measured by Sphygmocor XCEL
Time Frame
Change at 5 weeks from baseline
Title
Blood pressure
Description
Measured by electronic blood pressure monitor
Time Frame
Change at 5 weeks from baseline
Title
Whole body composition
Description
Measured by Dual Energy X-ray Absorptiometry
Time Frame
Change at 5 weeks from baseline
Title
Inflammation status
Description
Measured by ELISA
Time Frame
Change at 5 weeks from baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Human Intervention Studies Unit, Ulster University
City
Coleraine
State/Province
Co.Londonderry
ZIP/Postal Code
BT52 1SA
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
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