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

Sponsor
Liverpool John Moores University
Study ID
NCT07462871
Status
Not Yet Recruiting

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Conditions

  • Atherosclerosis Cardiovascular Disease
  • Dyslipidaemia
  • Metabolic Syndrome

Eligibility Criteria

Sex
ALL
Age
30 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Mar 10, 2026
Start date
Jun 30, 2026
Status verified
Mar 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Mediterranean-style diet
    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.
  • Experimental: Carnivore-style 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.

Primary Outcome Measure

LDL aggregation susceptibility [ Time Frame: Baseline and 3 weeks. ]

Central Contacts

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