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NCT Number: NCT07462871

Comparative Effects of Carnivore and Mediterranean-style Diets on LDL Aggregation and Cardiometabolic Health

The goal of this clinical trial is to learn whether following a Mediterranean-style diet or a Carnivore-style diet can improve heart and metabolic health in men and women aged 30-60 years with high LDL cholesterol.

The main questions it aims to answer are:

1. Does following a Mediterranean or Carnivore diet change how easily LDL cholesterol particles clump together (LDL aggregation susceptibility)? 2. Do these two diets have different effects on other measures of heart and metabolic health, such as blood fats, blood vessel function, and overall wellbeing?

Researchers will compare people who follow the Mediterranean-style diet with those who follow the Carnivore-style diet to see which diet produces more beneficial changes in cholesterol and heart health markers.

Participants will:

* Attend three visits at Liverpool John Moores University for screening and data collection. * Be randomly assigned to follow either the Mediterranean or Carnivore diet for 3 weeks, matched for calories and protein. * Provide fasting blood, urine, and stool samples before and after the diet period. * Complete non-invasive cardiovascular tests to measure blood vessel and heart function. * Take part in a short interview and complete questionnaires about their experience of following the diet.

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Key information

Conditions

Atherosclerosis Cardiovascular Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Dyslipidaemia Dyslipidemias Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Lipid Metabolism Disorders Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases Vascular Diseases

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male or female
  • 30-60 years of age
  • Elevated LDL cholesterol (LDL >3mmol/L and/or non-HDL cholesterol > 4mmol/L)
  • Not following any specific diet for health reasons.
  • Not currently taking lipid-lowering medications or supplements that may interfere with LDL levels.

Exclusion criteria

  • Pregnancy or breastfeeding.
  • Known food allergies or intolerances.
  • Previous history of disordered eating.
  • Currently taking cholesterol-lowering medication or supplements.

Treatment and study plan

Carnivore Diet

Dietary Supplement

The intervention diet will consist of isocaloric consumption of exclusively of animal-based products, including red meat, poultry, and limited amounts of dairy products for 3 weeks. The diet will exclude plant-based foods, such as fruits, vegetables, grains, legumes, nuts, and seeds to reflect a traditional Carnivore-style dietary pattern.

Mediterranean diet

Dietary Supplement

The intervention diet will consist of isocaloric consumption of foods typical of a traditional Mediterranean dietary pattern, including fruits, vegetables, whole grains, legumes, nuts, olive oil, and fish, for a period of 3 weeks. The diet will include moderate amounts of poultry and dairy products and limited amounts of red and processed meat, refined carbohydrates, and added sugars.

Primary outcomes

  1. LDL aggregation susceptibility

    Time frame: Baseline and 3 weeks.

    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 and 3 weeks.

    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 and 3 weeks.

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

Other outcomes

  1. Blood pressure

    Time frame: Baseline and 3 weeks.

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

  2. Flow-mediated dilation (FMD)

    Time frame: Baseline and 3 weeks.

    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.

  3. Plasma glucose

    Time frame: Baseline and 3 weeks.

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

  4. Dietary adherence

    Time frame: Baseline and 3 days during the intervention.

    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.

  5. Pulse wave velocity (PWV)

    Time frame: Baseline and 3 weeks.

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

  6. Carotid intima media thickness (CIMT)

    Time frame: Baseline and 3 weeks.

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

  7. Height

    Time frame: Baseline and 3 weeks.

    Height will be measured in metres using a stadiometer.

  8. Body weight

    Time frame: Baseline and 3 weeks.

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

  9. Body mass index (BMI)

    Time frame: Baseline and 3 weeks.

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

  10. Body fat percentage

    Time frame: Baseline and 3 weeks.

    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.

  11. Waist to hip ratio

    Time frame: Baseline and 3 weeks.

    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).

  12. Plasma insulin

    Time frame: Baseline and 3 weeks.

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

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

    Time frame: Baseline and 3 weeks.

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

  14. Qualitative interview

    Time frame: Post-intervention

    Participants will complete a semi-structured exit interview (~30-45 minutes) to explore their experiences of their assigned dietary intervention. Interviews will assess acceptability, feasibility, and perceived impacts of the diet and intervention procedures. 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.

Study contacts

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

Dr Richie Kirwan

CONTACT

[email protected]

Megan Wilson, BSc Nutrition

CONTACT

[email protected]

+447362317430

Sponsors and collaborators

Lead sponsor

Liverpool John Moores University

Other

Collaborators

  • University of Helsinki
  • Wihuri Research Institute

Registry information

Official study title

Comparative Effects of Carnivore and Mediterranean-style Diets on LDL Aggregation Susceptibility and Cardiometabolic Health

Acronym: MEDIVORE

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 10, 2026
Registry last updated
Mar 13, 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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