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NCT Number: NCT07474233

Associations Between Dietary Patterns, 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.

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Key information

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Pulse wave velocity (PWV)

    Time frame: Baseline upon enrollment.

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

  7. 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.

  8. Height

    Time frame: Baseline upon enrollment.

    Height will be measured in metres using a stadiometer.

  9. Body weight

    Time frame: Baseline upon enrollment.

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

  10. 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.

  11. 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.

  12. 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).

  13. 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.

  14. 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.

  15. 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).

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dr Richie Kirwan

CONTACT

[email protected]

Megan L Wilson, BSc Nutrition

CONTACT

[email protected]

+447362317430

Sponsors and collaborators

Lead sponsor

Liverpool John Moores University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 16, 2026
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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