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Not yet recruitingNCT07474233Updated Aug 26, 2026

Associations Between Dietary Patterns, LDL Aggregation, and Cardiometabolic Health

An observational study in Atherosclerosis Cardiovascular Disease, Metabolic Syndrome and Dyslipidaemia, sponsored by Liverpool John Moores University. Not yet recruiting at 1 site in United Kingdom. Open to participants aged 25 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-26.

Sponsored by Liverpool John Moores University · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
90
Ages
25 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • 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
03

Who can participate

Ages eligible
25 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-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.

Inclusion criteria

  • 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).

Exclusion criteria

Exclusion Criteria:

  • 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.
04

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
90 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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.

05

What researchers measure

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.

    Time frame: Baseline upon enrollment.

Secondary outcomes

  1. 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.

    Time frame: Baseline upon enrollment.

  2. Lipoprotein particle size

    Changes in lipoprotein particle size (diameter) will be measured via Nuclear Magnetic Resonance spectroscopy (NMR) and expressed in nanometers.

    Time frame: Baseline upon enrollment.

Other outcomes

  1. Qualitative interview

    Participants will complete a semi-structured interview (\~30-45 minutes) to explore their experiences of their chosen dietary pattern. Interviews will assess eating behaviour, attitudes, motivation, and perceived impact of the chosen diet. Question subsections include overall experience, practical challenges, social and lifestyle factors, and intentions to continue the diet. Interviews will be conducted in person or online via Microsoft Teams, audio-recorded with consent, transcribed verbatim, and anonymised prior to thematic analysis.

    Time frame: Baseline upon enrollment.

  2. Blood pressure

    Change in resting systolic and diastolic blood pressure. Blood pressure reflects cardiovascular function and may be influenced by dietary fat type and nutrient composition.

    Time frame: Baseline upon enrollment.

  3. Flow-mediated dilation (FMD)

    Change in blood vessel function will be assessed using a non-invasive ultrasound test to measure how well the arteries widen (dilate) in response to increased blood flow.

    Time frame: Baseline upon enrollment.

  4. Plasma glucose

    Changes in fasting blood glucose will be assessed via biochemical plasma analysis of a venous blood sample and recorded in mmol/L.

    Time frame: Baseline upon enrollment.

  5. Dietary adherence

    Participants' self-reported adherence to the assigned diet will be collected through completion of a 3-day online food log/diary via a mobile phone application.

    Time frame: Baseline prior to enrollment.

  6. Pulse wave velocity (PWV)

    Non-invasive ultrasound measurement of how quickly blood pressure waves move through the carotid artery.

    Time frame: Baseline upon enrollment.

  7. Carotid intima media thickness (CIMT)

    CIMT is a non-invasive ultrasound method used to measure the thickness of an artery wall which can give information about blood vessel health.

    Time frame: Baseline upon enrollment.

  8. Height

    Height will be measured in metres using a stadiometer.

    Time frame: Baseline upon enrollment.

  9. Body weight

    Changes in body weight will be measured in kilograms using a SECA bioelectrical impedance analyser.

    Time frame: Baseline upon enrollment.

  10. Body mass index (BMI)

    BMI will be calculated calculated by dividing an adult's weight in kilograms by their height in meters squared.

    Time frame: Baseline upon enrollment.

  11. Body fat percentage

    Using a SECA bioelectrical impedance analyser, body fat percentage will be estimated by sending a weak, painless electrical current through the body, measuring the resistance (impedance) encountered.

    Time frame: Baseline upon enrollment.

  12. Waist to hip ratio

    Waist to hip ratio will be measured using a measuring tape to measure the narrowest point of the waist and the widest point of the hips. The ratio will be calculated by dividing waist circumference by hip circumference (WHR = Waist ÷ Hip) using the same unit of measurement (cm or inches).

    Time frame: Baseline upon enrollment.

  13. Plasma insulin

    Changes in fasting blood insulin levels will be assessed via biochemical plasma analysis of a venous blood sample and recorded in mcU/mL.

    Time frame: Baseline upon enrollment.

  14. Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)

    HOMA-IR measures insulin resistance using fasting blood glucose and insulin, with a score of \> 2.0 or 2.5 typically indicating resistance.

    Time frame: Baseline upon enrollment.

  15. International Physical Activity Questionnaire (IPAQ)

    A validated self-report questionnaire assessing physical activity performed during the previous 7 days. Participants report frequency and duration of vigorous activity, moderate activity, walking, and sedentary time. Responses are used to estimate total habitual physical activity (e.g., MET-minutes/week).

    Time frame: Baseline upon enrollment.

  16. Need for Cognition Scale (NCS)

    An 18-item self-report scale measuring an individual's tendency to engage in and enjoy effortful cognitive activity. Items are rated on a Likert-type scale (1-5; strongly disagree to strongly agree). Scores are summed or averaged, with higher scores indicating greater need for cognition.

    Time frame: Baseline upon enrollment.

  17. Generic Conspiracist Beliefs Scale (GCBS)

    A 15-item self-report questionnaire assessing general endorsement of conspiracy beliefs across multiple domains. Items are rated on a 5-point Likert scale (1 = definitely not true to 5 = definitely true). Higher scores indicate stronger conspiracist beliefs.

    Time frame: Baseline upon enrollment.

  18. Media and Technology Usage and Attitudes Scale (MTUAS)

    A self-report measure assessing frequency of digital media and technology use and attitudes toward technology. Items assessing usage are rated on Likert-type frequency scales (e.g., 1 = never to 10 = all the time), while attitude items use agreement Likert scales. Higher scores reflect greater usage or stronger attitudes toward technology.

    Time frame: Baseline upon enrollment.

  19. Belief in Science Scale (BISS)

    A self-report questionnaire measuring the extent to which individuals view science as a reliable and authoritative source of knowledge. Items are rated on a 6-point Likert scale (strongly disagree to strongly agree), with higher scores indicating stronger belief in science.

    Time frame: Baseline upon enrollment.

  20. Scientific Determinism Scale (SDS)

    A self-report scale assessing beliefs that human behaviour and events are determined by scientific and physical laws. Items are rated on a Likert-type agreement scale (e.g., 1 = strongly disagree to 7 = strongly agree), with higher scores indicating stronger endorsement of scientific determinism.

    Time frame: Baseline upon enrollment.

  21. Social Identification Scale (SIS)

    A self-report measure assessing the degree to which individuals identify with a specific social group. Items are rated on a Likert-type agreement scale (typically 1-7), measuring aspects such as group belonging, attachment, and identification. Higher scores indicate stronger social identification.

    Time frame: Baseline upon enrollment.

06

Study locations

1 site
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07474233
Lead sponsor
Liverpool John Moores University
Responsible party
Megan Wilson (Principal Investigator, Liverpool John Moores University) — Principal investigator
First posted
Mar 16, 2026
Start date
Oct 2026 (estimated)
Primary completion
May 2027 (estimated)
Completion
May 2027 (estimated)
Last update
Aug 26, 2026

Study contacts

Megan L Wilson, BSc Nutrition
Contact
M.L.Wilson@ljmu.ac.uk
+447362317430
Dr Richie Kirwan
Contact
R.P.Kirwan@ljmu.ac.uk
Richie Kirwan
study director · Liverpool John Moores University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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