An interventional study of Carnivore Diet and Mediterranean Diet 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 30 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-13.
Sponsored by Liverpool John Moores University · Not applicable, Interventional, and Prevention
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:
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:
Exclusion Criteria:
Participants will be provided with an isocaloric diet rich in fruits, vegetables, whole grains, legumes, nuts, olive oil, and fish, consistent with and optimised to reflect a traditional Mediterranean dietary pattern. The diet will include moderate amounts of poultry and dairy products and limited amounts of red and processed meat, refined carbohydrates, and added sugars.
Dietary Supplement: Mediterranean Diet
Participants will be provided with an isocaloric diet consisting primarily of animal-based products, including red meat, poultry, and limited amounts of dairy products. The diet will exclude plant-based foods, such as fruits, vegetables, grains, legumes, nuts, and seeds to reflect a traditional Carnivore-style dietary pattern.
Dietary Supplement: Carnivore Diet
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.
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.
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 and 3 weeks.
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 and 3 weeks.
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 and 3 weeks.
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 and 3 weeks.
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 and 3 weeks.
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 and 3 weeks.
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 and 3 days during the intervention.
Pulse wave velocity (PWV)
Non-invasive ultrasound measurement of how quickly blood pressure waves move through the carotid artery.
Time frame: Baseline and 3 weeks.
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 and 3 weeks.
Height
Height will be measured in metres using a stadiometer.
Time frame: Baseline and 3 weeks.
Body weight
Changes in body weight will be measured in kilograms using a SECA bioelectrical impedance analyser.
Time frame: Baseline and 3 weeks.
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 and 3 weeks.
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 and 3 weeks.
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 and 3 weeks.
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 and 3 weeks.
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 and 3 weeks.
Qualitative interview
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.
Time frame: Post-intervention
Plan to share: Undecided — The research team intends to consider sharing de-identified individual participant data after publication of the primary results, subject to participant consent, ethical approval, and institutional data governance review. A formal IPD sharing plan will be developed in collaboration with Liverpool John Moores University once data has been fully analysed.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Liverpool John Moores University