Atherosclerosis Cardiovascular DiseaseNCT07474233
Associations Between Dietary Patterns, LDL Aggregation, and Cardiometabolic Health
An observational study of Atherosclerosis Cardiovascular Disease and Metabolic Syndrome, run by Liverpool John Moores University at 1 site in United Kingdom.
Trial summary
This study aims to investigate the extent to which vegan or plant-based, omnivorous, and carnivore dietary patterns affect LDL aggregation susceptibility (the affinity for LDL cholesterol particles to clump together in the blood), which may promote plaque build-up in arteries. Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis Cardiovascular Disease, Metabolic Syndrome, Dyslipidaemia
- How many people
- 90 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2026to May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Individuals based in or around the Liverpool and North West area that habitually follow one of the three pre-specified dietary patterns.
Who may be able to join
- Adults aged 25-60 years.
- BMI range (18.5-29.9 kg/m²).
- Following one of the specified dietary patterns (vegan/plant-based, carnivore, or omnivorous) for a minimum of 6 months.
- Self-identified as health-focused (i.e., intentionally following the diet for perceived health benefits).
Who cannot join
- BMI outside the stated range (<18.5 or ≥30 kg/m²).
- Use of lipid-lowering medications or supplements that may interfere with LDL levels.
- Pregnancy or breastfeeding.
- Any significant deviation from the specified diet within the last month.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dr Richie Kirwan contact
United Kingdom1 site
Tom Reilly Building, Liverpool John Moores University
Liverpool, ENG, L3 3AF
Megan L Wilson, 07362317430, M.L.Wilson@ljmu.ac.uk
Dr Richie Kirwan, R.P.Kirwan@ljmu.ac.uk
About this study
Official title: Associations Between Dietary Pattern Adherence, LDL Aggregation, and Cardiometabolic Health: A Cross-sectional Analysis.
This study aims to investigate the extent to which vegan or plant-based, omnivorous, and carnivore dietary patterns affect LDL aggregation susceptibility (the affinity for LDL cholesterol particles to clump together in the blood), which may promote plaque build-up in arteries. Using a cross-sectional mixed-methods design, the study will measure LDL aggregation, blood lipids, and other metabolic biomarkers in individuals following these diets, and combine these data with dietary and behavioural information to examine links with cardiovascular and metabolic health.
- Conditions
- Atherosclerosis Cardiovascular Disease, Metabolic Syndrome, Dyslipidaemia, Endothelial Dysfunction
- Keywords
- LDL aggregation, Dietary patterns, Atherosclerosis, Cardiovascular disease, Onmivore diet, Vegan diet, Carnivore diet, Lipid profile, Cardiometabolic health
- Medical subject headings
- Metabolic Syndrome, Dyslipidemias, Atherosclerosis, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Vegan or plant-based diet | Individuals who identify as adhering to a vegan or plant-based diet habitually for a minimum period of six months. | |
| Carnivore diet | Individuals who identify as adhering to a carnivore diet composed exclusively of animal-based products habitually for a minimum period of six months. | |
| Omnivore diet | Individuals who identify as adhering to an omnivorous (animal and plant-based) diet habitually for a minimum period of six months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL aggregation susceptibility
To measure changes in how easily LDL cholesterol particles 'clump' together in the blood vessels from baseline to post-intervention, assessed via plasma lipid and lipoprotein analysis.
Measured: Baseline upon enrollment.
Secondary outcomes (2)
Plasma lipid and lipoprotein profile
Changes in plasma levels of total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides will be determined via enzymatic analysis and measured in mmol/L.
Measured: Baseline upon enrollment.
Lipoprotein particle size
Changes in lipoprotein particle size (diameter) will be measured via Nuclear Magnetic Resonance spectroscopy (NMR) and expressed in nanometers.
Measured: Baseline upon enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study startOct 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerosis Cardiovascular DiseaseStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liverpool John Moores University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Megan Wilson, Liverpool John Moores University
- Investigators
- Richie Kirwan, Study director, Liverpool John Moores University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07474233
- Sponsor's protocol ID
- 260106LJMUREC269
- Status last verified
- Aug 2026
- First submitted
- 11 Mar 2026
- Last updated
- 26 Aug 2026
- 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 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Associations Between Dietary Pattern Adherence, LDL Aggregation, and Cardiometabolic Health: A Cross-sectional Analysis.
- ClinicalTrials.gov ID
- NCT07474233
- Acronym / sponsor ID
- 260106LJMUREC269
- Conditions
- Atherosclerosis Cardiovascular Disease, Metabolic Syndrome, Dyslipidaemia, Endothelial Dysfunction
- Keywords
- LDL aggregation, Dietary patterns, Atherosclerosis, Cardiovascular disease, Onmivore diet, Vegan diet, Carnivore diet, Lipid profile
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Liverpool John Moores UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 16 Mar 2026 (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.
This study aims to investigate the extent to which vegan or plant-based, omnivorous, and carnivore dietary patterns affect LDL aggregation susceptibility (the affinity for LDL cholesterol particles to clump together in the blood), which may promote plaque build-up in arteries. Using a cross-sectional mixed-methods design, the study will measure LDL aggregation, blood lipids, and other metabolic biomarkers in individuals following these diets, and combine these data with dietary and behavioural information to examine links with cardiovascular and metabolic health.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vegan or plant-based diet | – | –Individuals who identify as adhering to a vegan or plant-based diet habitually for a minimum period of six months. |
| Carnivore diet | – | –Individuals who identify as adhering to a carnivore diet composed exclusively of animal-based products habitually for a minimum period of six months. |
| Omnivore diet | – | –Individuals who identify as adhering to an omnivorous (animal and plant-based) diet habitually for a minimum period of six months. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Individuals based in or around the Liverpool and North West area that habitually follow one of the three pre-specified dietary patterns.
Key inclusion criteria (4 listed)
- Adults aged 25-60 years.
- BMI range (18.5-29.9 kg/m²).
- Following one of the specified dietary patterns (vegan/plant-based, carnivore, or omnivorous) for a minimum of 6 months.
- Self-identified as health-focused (i.e., intentionally following the diet for perceived health benefits).
Key exclusion criteria (4 listed)
- BMI outside the stated range (<18.5 or ≥30 kg/m²).
- Use of lipid-lowering medications or supplements that may interfere with LDL levels.
- Pregnancy or breastfeeding.
- Any significant deviation from the specified diet within the last month.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
LDL aggregation susceptibility
Time frame: Baseline upon enrollment.
To measure changes in how easily LDL cholesterol particles 'clump' together in the blood vessels from baseline to post-intervention, assessed via plasma lipid and lipoprotein analysis.
2 secondary outcomes
Plasma lipid and lipoprotein profile
Time frame: Baseline upon enrollment.
Lipoprotein particle size
Time frame: Baseline upon enrollment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- 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.
Dr Richie Kirwan contact
Richie Kirwan study director
Liverpool John Moores University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerosis Cardiovascular Disease and Metabolic Syndrome, run by Liverpool John Moores University 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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 26 Aug 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Megan L Wilson, BSc Nutrition (+447362317430, M.L.Wilson@ljmu.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LDL aggregation susceptibility (time frame: Baseline upon enrollment.). 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 26 Aug 2026.