Comparative Effects of Carnivore and Mediterranean-style Diets on LDL Aggregation Susceptibility and Cardiometabolic Health
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- LDL aggregation susceptibility
研究概览
简要总结
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:
- Does following a Mediterranean or Carnivore diet change how easily LDL cholesterol particles clump together (LDL aggregation susceptibility)?
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Pregnancy or breastfeeding.
- •Known food allergies or intolerances.
- •Previous history of disordered eating.
- •Currently taking cholesterol-lowering medication or supplements.
研究组 & 干预措施
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.
干预措施: Mediterranean Diet (Dietary Supplement)
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.
干预措施: Carnivore Diet (Dietary Supplement)
结局指标
主要结局
LDL aggregation susceptibility
时间窗: Baseline and 3 weeks.
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.
次要结局
- Plasma lipid and lipoprotein profile(Baseline and 3 weeks.)
- Lipoprotein particle size(Baseline and 3 weeks.)
研究者
Megan Wilson
Principal Investigator
Liverpool John Moores University