Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Wihuri Research Institute | OTHER |
| University of Helsinki | OTHER |
Not provided
Not provided
Not provided
Not provided
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:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma lipid and lipoprotein profile | Changes in plasma levels of total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides will be determined via enzymatic analysis and measured in mmol/L. | Baseline and 3 weeks. |
| Lipoprotein particle size |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure | Change in resting systolic and diastolic blood pressure. Blood pressure reflects cardiovascular function and may be influenced by dietary fat type and nutrient composition. | Baseline and 3 weeks. |
| Flow-mediated dilation (FMD) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Megan Wilson, BSc Nutrition | Contact | +447362317430 | M.L.Wilson@ljmu.ac.uk | |
| Dr Richie Kirwan | Contact | R.P.Kirwan@ljmu.ac.uk |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tom Reilly Building, Liverpool John Moores University | Liverpool | L3 3AF | United Kingdom |
The research team intends to consider sharing de-identified individual participant data after publication of the primary results, subject to participant consent, ethical approval, and institutional data governance review. A formal IPD sharing plan will be developed in collaboration with Liverpool John Moores University once data has been fully analysed.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
Changes in lipoprotein particle size (diameter) will be measured via Nuclear Magnetic Resonance spectroscopy (NMR) and expressed in nanometers.
| Baseline and 3 weeks. |
Change in blood vessel function will be assessed using a non-invasive ultrasound test to measure how well the arteries widen (dilate) in response to increased blood flow.
| Baseline and 3 weeks. |
| Plasma glucose | Changes in fasting blood glucose will be assessed via biochemical plasma analysis of a venous blood sample and recorded in mmol/L. | Baseline and 3 weeks. |
| Dietary adherence | Participants' self-reported adherence to the assigned diet will be collected through completion of a 3-day online food log/diary via a mobile phone application. | Baseline and 3 days during the intervention. |
| Pulse wave velocity (PWV) | Non-invasive ultrasound measurement of how quickly blood pressure waves move through the carotid artery. | Baseline and 3 weeks. |
| Carotid intima media thickness (CIMT) | CIMT is a non-invasive ultrasound method used to measure the thickness of an artery wall which can give information about blood vessel health. | Baseline and 3 weeks. |
| Height | Height will be measured in metres using a stadiometer. | Baseline and 3 weeks. |
| Body weight | Changes in body weight will be measured in kilograms using a SECA bioelectrical impedance analyser. | Baseline and 3 weeks. |
| Body mass index (BMI) | BMI will be calculated calculated by dividing an adult's weight in kilograms by their height in meters squared. | Baseline and 3 weeks. |
| Body fat percentage | Using a SECA bioelectrical impedance analyser, body fat percentage will be estimated by sending a weak, painless electrical current through the body, measuring the resistance (impedance) encountered. | Baseline and 3 weeks. |
| Waist to hip ratio | Waist to hip ratio will be measured using a measuring tape to measure the narrowest point of the waist and the widest point of the hips. The ratio will be calculated by dividing waist circumference by hip circumference (WHR = Waist รท Hip) using the same unit of measurement (cm or inches). | Baseline and 3 weeks. |
| Plasma insulin | Changes in fasting blood insulin levels will be assessed via biochemical plasma analysis of a venous blood sample and recorded in mcU/mL. | Baseline and 3 weeks. |
| Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) | HOMA-IR measures insulin resistance using fasting blood glucose and insulin, with a score of > 2.0 or 2.5 typically indicating resistance. | Baseline and 3 weeks. |
| Qualitative interview | Participants will complete a semi-structured exit interview (~30-45 minutes) to explore their experiences of their assigned dietary intervention. Interviews will assess acceptability, feasibility, and perceived impacts of the diet and intervention procedures. Question subsections include overall experience, practical challenges, social and lifestyle factors, and intentions to continue the diet. Interviews will be conducted in person or online via Microsoft Teams, audio-recorded with consent, transcribed verbatim, and anonymised prior to thematic analysis. | Post-intervention |
| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D050171 | Dyslipidemias |
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D052439 | Lipid Metabolism Disorders |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D038441 | Diet, Mediterranean |
| ID | Term |
|---|---|
| D000095500 | Diet, Plant-Based |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
Not provided
Not provided