CVDNCT03967678
Omega (n)-3 PUFA Enriched Beef & Health Outcomes.
A study testing Three portions per week (690g beef (raw weight)) for 5 weeks in people with CVD and Cholesterol; Metabolic Disorder, run by University of Ulster at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- CVD, Cholesterol; Metabolic Disorder, Inflammation
- What is being tested?
- Three portions per week (690g beef (raw weight)) for 5 weeks
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Nov 2018to 19 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Human Intervention Studies Unit, Ulster University
Coleraine, Co.Londonderry, BT52 1SA
About this study
Official title: Omega (n)-3 PUFA Enriched Beef to Improve Circulating Lipid Concentrations and CVD Risk Markers in Adults: a Randomised Controlled Study.
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
- Being tested
- Three portions per week (690g beef (raw weight)) for 5 weeks
- Keywords
- enriched beef, omega, poly unsaturated fatty acids (PUFA), cholesterol, grass fed
- Medical subject headings
- Metabolic Diseases, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three portions per week (690g beef (raw weight)) for 5 weeksDietary supplement
Lunches served in Human Intervention Studies Unit
| Study group | Role | What they receive |
|---|---|---|
| Beef from standard supply | Placebo comparator | Not described Receives: Dietary Supplement: Three portions per week (690g beef (raw weight)) for 5 weeks |
| n-3 enriched beef from dietary supplement finished cattle | Experimental | Not described Receives: Dietary Supplement: Three portions per week (690g beef (raw weight)) for 5 weeks |
| n-3 enriched beef from grass finished cattle | Active comparator | Not described Receives: Dietary Supplement: Three portions per week (690g beef (raw weight)) for 5 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cholesterol levels
Plasma cholesterol measured colormetrically
Measured: Change at 5 weeks from baseline
Secondary outcomes (6)
Lipid profile
Plasma lipids measured colormetrically
Measured: Change at 5 weeks from baseline
Polyunsaturated fatty acid profile
Serum fatty acids measured by GC-MS
Measured: Change at 5 weeks from baseline
Pulse Wave Velocity
Measured by Sphygmocor XCEL
Measured: Change at 5 weeks from baseline
Blood pressure
Measured by electronic blood pressure monitor
Measured: Change at 5 weeks from baseline
Whole body composition
Measured by Dual Energy X-ray Absorptiometry
Measured: Change at 5 weeks from baseline
Inflammation status
Measured by ELISA
Measured: Change at 5 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start7 Nov 2018
- Primary completion19 Apr 2019
- Study completion19 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CVDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blind randomised controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulster
- Sponsor type
- University, hospital or other
- Collaborators
- Dunbia, Northern Ireland
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03967678
- Sponsor's protocol ID
- 18/WS/0149
- Status last verified
- May 2019
- First submitted
- 27 May 2019
- Last updated
- 3 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omega (n)-3 PUFA Enriched Beef to Improve Circulating Lipid Concentrations and CVD Risk Markers in Adults: a Randomised Controlled Study.
- ClinicalTrials.gov ID
- NCT03967678
- Acronym / sponsor ID
- 18/WS/0149
- Conditions
- CVD, Cholesterol; Metabolic Disorder, Inflammation
- Keywords
- enriched beef, omega, poly unsaturated fatty acids (PUFA), cholesterol, grass fed
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of UlsterUniversity, hospital or other
- Collaborators
- Dunbia, Northern Ireland
- Study start
- 7 Nov 2018 (actual)
- Primary completion
- 19 Apr 2019 (actual)
- Study completion
- 19 Apr 2019 (actual)
- First posted
- 30 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Double blind randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Three portions per week (690g beef (raw weight)) for 5 weeksLunches served in Human Intervention Studies Unit | Dietary supplement | Beef from standard supply, n-3 enriched beef from dietary supplement finished cattle, n-3 enriched beef from grass finished cattle |
Primary outcome
Cholesterol levels
Time frame: Change at 5 weeks from baseline
Plasma cholesterol measured colormetrically
6 secondary outcomes
Lipid profile
Time frame: Change at 5 weeks from baseline
Polyunsaturated fatty acid profile
Time frame: Change at 5 weeks from baseline
Pulse Wave Velocity
Time frame: Change at 5 weeks from baseline
Blood pressure
Time frame: Change at 5 weeks from baseline
Whole body composition
Time frame: Change at 5 weeks from baseline
Inflammation status
Time frame: Change at 5 weeks from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Three portions per week (690g beef (raw weight)) for 5 weeks in people with CVD and Cholesterol; Metabolic Disorder, run by University of Ulster at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cholesterol levels (time frame: Change at 5 weeks from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2019.