Associations Between Dietary Patterns, LDL Aggregation, and Cardiometabolic Health

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age25-60
SponsorLiverpool John Moores University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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).

Disqualifiers

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 population

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

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

90 Participants
are grouped into 3 trial groups
Group A: Vegan or plant-based diet
Group B: Carnivore diet
Group C: Omnivore diet

Trial outcomes

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.

Sponsors and contacts

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