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

NCT07462871 | Not Yet Recruiting

• 1 other identifier: SLNMWILSRCT
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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:

• 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.

Conditions

Atherosclerosis Cardiovascular Disease; Metabolic Syndrome; Dyslipidaemia

Keywords

Atherosclerosis; ASCVD; Diet, carbohydrate-restricted; Ketogenic diet; LDL aggregation; Low-density lipoproteins; Lipoproteins; Lipid metabolism

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 3 weeks.

Secondary Outcomes (2)

• Plasma lipid and lipoprotein profile

  Baseline and 3 weeks.

• Lipoprotein particle size

  Baseline and 3 weeks.

Other Outcomes (14)

• Blood pressure

  Baseline and 3 weeks.

• Flow-mediated dilation (FMD)

  Baseline and 3 weeks.

• Plasma glucose

  Baseline and 3 weeks.

Study Arms (2)

Mediterranean-style diet

ACTIVE COMPARATOR

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.

Dietary Supplement: Mediterranean Diet

Carnivore-style diet

EXPERIMENTAL

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.

Dietary Supplement: Carnivore Diet

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.

Carnivore-style diet

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.

Mediterranean-style diet

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female
• 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.

You may not qualify if:

• Pregnancy or breastfeeding.
• Known food allergies or intolerances.
• Previous history of disordered eating.
• Currently taking cholesterol-lowering medication or supplements.

Sponsors & Collaborators

• Liverpool John Moores University: lead
• Wihuri Research Institute: collaborator
• University of Helsinki: collaborator

Study Sites (1)

Tom Reilly Building, Liverpool John Moores University

Liverpool, L3 3AF, United Kingdom

Location

MeSH Terms

Conditions

Metabolic Syndrome; Dyslipidemias; Atherosclerosis

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Lipid Metabolism Disorders; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Megan Wilson, BSc Nutrition

CONTACT

+447362317430; M.L.Wilson@ljmu.ac.uk

Dr Richie Kirwan

CONTACT

R.P.Kirwan@ljmu.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: March 10, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

GB (1)