Associations Between Dietary Patterns, LDL Aggregation, and Cardiometabolic Health: A Cross-sectional Analysis.

March 11, 2026 updated by: Megan Wilson, Liverpool John Moores University

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

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.

Description

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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline upon enrollment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma lipid and lipoprotein profile
Time Frame: Baseline upon enrollment.
Changes in plasma levels of total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides will be determined via enzymatic analysis and measured in mmol/L.
Baseline upon enrollment.
Lipoprotein particle size
Time Frame: Baseline upon enrollment.
Changes in lipoprotein particle size (diameter) will be measured via Nuclear Magnetic Resonance spectroscopy (NMR) and expressed in nanometers.
Baseline upon enrollment.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Qualitative interview
Time Frame: Baseline upon enrollment.
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.
Baseline upon enrollment.
Blood pressure
Time Frame: Baseline upon enrollment.
Change in resting systolic and diastolic blood pressure. Blood pressure reflects cardiovascular function and may be influenced by dietary fat type and nutrient composition.
Baseline upon enrollment.
Flow-mediated dilation (FMD)
Time Frame: Baseline upon enrollment.
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.
Baseline upon enrollment.
Plasma glucose
Time Frame: Baseline upon enrollment.
Changes in fasting blood glucose will be assessed via biochemical plasma analysis of a venous blood sample and recorded in mmol/L.
Baseline upon enrollment.
Dietary adherence
Time Frame: Baseline prior to enrollment.
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.
Baseline prior to enrollment.
Pulse wave velocity (PWV)
Time Frame: Baseline upon enrollment.
Non-invasive ultrasound measurement of how quickly blood pressure waves move through the carotid artery.
Baseline upon enrollment.
Carotid intima media thickness (CIMT)
Time Frame: Baseline upon enrollment.
CIMT is a non-invasive ultrasound method used to measure the thickness of an artery wall which can give information about blood vessel health.
Baseline upon enrollment.
Height
Time Frame: Baseline upon enrollment.
Height will be measured in metres using a stadiometer.
Baseline upon enrollment.
Body weight
Time Frame: Baseline upon enrollment.
Changes in body weight will be measured in kilograms using a SECA bioelectrical impedance analyser.
Baseline upon enrollment.
Body mass index (BMI)
Time Frame: Baseline upon enrollment.
BMI will be calculated calculated by dividing an adult's weight in kilograms by their height in meters squared.
Baseline upon enrollment.
Body fat percentage
Time Frame: Baseline upon enrollment.
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.
Baseline upon enrollment.
Waist to hip ratio
Time Frame: Baseline upon enrollment.
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).
Baseline upon enrollment.
Plasma insulin
Time Frame: Baseline upon enrollment.
Changes in fasting blood insulin levels will be assessed via biochemical plasma analysis of a venous blood sample and recorded in mcU/mL.
Baseline upon enrollment.
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Time Frame: Baseline upon enrollment.
HOMA-IR measures insulin resistance using fasting blood glucose and insulin, with a score of > 2.0 or 2.5 typically indicating resistance.
Baseline upon enrollment.
International Physical Activity Questionnaire (IPAQ)
Time Frame: Baseline upon enrollment.
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).
Baseline upon enrollment.
Need for Cognition Scale (NCS)
Time Frame: Baseline upon enrollment.
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.
Baseline upon enrollment.
Generic Conspiracist Beliefs Scale (GCBS)
Time Frame: Baseline upon enrollment.
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.
Baseline upon enrollment.
Media and Technology Usage and Attitudes Scale (MTUAS)
Time Frame: Baseline upon enrollment.
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.
Baseline upon enrollment.
Belief in Science Scale (BISS)
Time Frame: Baseline upon enrollment.
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.
Baseline upon enrollment.
Scientific Determinism Scale (SDS)
Time Frame: Baseline upon enrollment.
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.
Baseline upon enrollment.
Social Identification Scale (SIS)
Time Frame: Baseline upon enrollment.
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.
Baseline upon enrollment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Liverpool John Moores University

Investigators

  • Study Director: Richie Kirwan, Liverpool John Moores University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

March 11, 2026

First Submitted That Met QC Criteria

March 11, 2026

First Posted (Actual)

March 16, 2026

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 260106LJMUREC269

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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