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.
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.
Pregnancy or breastfeeding.
Known food allergies or intolerances.
Previous history of disordered eating.
Currently taking cholesterol-lowering medication or supplements.
Parallel
Carnivore Diet
Dietary supplementThe 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 supplementThe 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.
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.
Lipoprotein particle size
Changes in lipoprotein particle size (diameter) will be measured via Nuclear Magnetic Resonance spectroscopy (NMR) and expressed in nanometers.
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.
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.
Plasma glucose
Changes in fasting blood glucose will be assessed via biochemical plasma analysis of a venous blood sample and recorded in mmol/L.
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.
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Liverpool John Moores University
Lead sponsor
Wihuri Research Institute
Collaborator
University of Helsinki
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
