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Not yet recruiting NCT07462871

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

No phase Interventional Atherosclerosis Cardiovascular Disease Metabolic Syndrome Dyslipidaemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Carnivore Diet, Mediterranean Diet.
Who it may be relevant to
Registry conditions: Atherosclerosis Cardiovascular Disease, Metabolic Syndrome, Dyslipidaemia. Basic parameters: 30 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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 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.
  • Dietary supplement Mediterranean 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.

Primary outcome measures

  • LDL aggregation susceptibility [Time frame: Baseline and 3 weeks.]
Secondary outcome measures (2)
  • Plasma lipid and lipoprotein profile [Time frame: Baseline and 3 weeks.]
  • Lipoprotein particle size [Time frame: Baseline and 3 weeks.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United Kingdom · 1 center
  • Tom Reilly Building, Liverpool John Moores University — Liverpool

Identifiers

NCT: NCT07462871 · SLNMWILSRCT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗