NCT07474233

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
10mo left

Started May 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
May 2026May 2027

First Submitted

Initial submission to the registry

March 11, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 16, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

March 11, 2026

Last Update Submit

March 11, 2026

Conditions

Keywords

LDL aggregationDietary patternsAtherosclerosisCardiovascular diseaseOnmivore dietVegan dietCarnivore dietLipid profileCardiometabolic health

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline upon enrollment.

Secondary Outcomes (2)

  • Plasma lipid and lipoprotein profile

    Baseline upon enrollment.

  • Lipoprotein particle size

    Baseline upon enrollment.

Other Outcomes (21)

  • Qualitative interview

    Baseline upon enrollment.

  • Blood pressure

    Baseline upon enrollment.

  • Flow-mediated dilation (FMD)

    Baseline upon enrollment.

  • +18 more other outcomes

Study Arms (3)

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.

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Individuals based in or around the Liverpool and North West area that habitually follow one of the three pre-specified dietary patterns.

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tom Reilly Building, Liverpool John Moores University

Liverpool, ENG, L3 3AF, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, serum, plasma and urine will be collected and retained for analysis.

MeSH Terms

Conditions

Metabolic SyndromeDyslipidemiasAtherosclerosisCardiovascular Diseases

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesLipid Metabolism DisordersArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Richie Kirwan

    Liverpool John Moores University

    STUDY DIRECTOR

Central Study Contacts

Megan L Wilson, BSc Nutrition

CONTACT

Dr Richie Kirwan

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 11, 2026

First Posted

March 16, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

March 16, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations