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

Liverpool John Moores University

Status: Begins enrollment in 1 month

Conditions: Atherosclerosis Cardiovascular Disease; Dyslipidaemia; Metabolic Syndrome

Treatments: Dietary Supplement: Carnivore Diet; Dietary Supplement: Mediterranean Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT07462871

SLNMWILSRCT

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 30 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Mediterranean-style diet

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Mediterranean Diet

Carnivore-style diet

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Carnivore Diet