Atherosclerosis Cardiovascular Disease, Dyslipidaemia, Metabolic Syndrome
Conditions
Keywords
Atherosclerosis, ASCVD, Diet, carbohydrate-restricted, Ketogenic diet, LDL aggregation, Low-density lipoproteins, Lipoproteins, Lipid metabolism
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTCarnivore 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.
DIETARY_SUPPLEMENTMediterranean Diet
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.
Sponsors
Liverpool John Moores University
Wihuri Research Institute
University of Helsinki
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LDL aggregation susceptibility | 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
| Measure | Time frame | Description |
|---|---|---|
| Plasma lipid and lipoprotein profile | 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. |
| Lipoprotein particle size | Baseline and 3 weeks. | Changes in lipoprotein particle size (diameter) will be measured via Nuclear Magnetic Resonance spectroscopy (NMR) and expressed in nanometers. |
Countries
United Kingdom
Contacts
CONTACTMegan Wilson, BSc Nutrition
CONTACTDr Richie Kirwan
Outcome results
None listed