The INTER-CARDIO Study: The Impact of Commonly Consumed Fat on Cardiovascular
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Endothelial function
研究概览
简要总结
The purpose of this study is to investigate whether there are differences in postprandial cardiometabolic metabolic indices following interesterified fats used commercially versus application appropriate non- interesterifed alternative fat.
详细描述
Aim: The current study aims to investigate the acute effects of commercially available interesterified fat versus versus application appropriate non- interesterifed alternative fat on 8 h postprandial cardiometabolic outcomes.
Hypothesis
Interesterified fat will induce a different cardiomtabolic response compared to a non interesterifed, application appropriate fat.
Subjects: Participants will include 40 healthy male and female volunteers aged between the ages of 35 and 75 years (since during this age metabolic changes start to take place).
Power calculation: Based on previous studies carried out by our group at King's College London, a sample size of 20 participants (males and females separately) will allow a 2.16% (percentage unit) difference in FMD to be detected (90% power, 0.05 alpha, SD 2.9. 50 participants will be recruited allowing for a 20% dropout rate.
Expected value:The study will provide novel information on the acute effects of commercially relevant processed fats on postprandial lipaemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females aged 35-75 years
- •Healthy (free of diagnosed diseases listed in exclusion criteria)
- •Able to understand the information sheet and willing to comply with study protocol
- •Able to give informed consent
排除标准
- •Medical history of myocardial infarction, angina, thrombosis, stroke, cancer, liver or bowel disease or diabetes
- •Body mass index < 20 kg/m2 or > 35 kg/m2
- •Plasma cholesterol ≥7.5 mmol/L
- •Plasma triacylglycerol > 3 mmol/L
- •Plasma glucose > 7 mmol/L
- •Blood pressure ≥140/90 mmHg
- •Current use of antihypertensive or lipid lowering medications
- •Alcohol intake exceeding a moderate intake (> 28 units per week)
- •Current cigarette smoker (or quit within the last 6 months)
- •≥ 20% 10-year risk of CVD as calculated using a risk calculator
结局指标
主要结局
Endothelial function
时间窗: Up to 8 hours
Flow mediated dilatation
Postprandial lipaemic response
时间窗: Up to 8 hours
Area under plasma TAG concentration/ time curve
次要结局
- Inflammatory response(Up to 8 hours)
- Postprandial lipaemic response(Up to 8 hours)
- Metabolomic for assessment of atherogenic potential (lipoprotein) analysis(Up to 8 hours)
- Glycaemic response(Up to 8 hours)
- Insulinaemic response(Up to 8 hours)
- Nitric oxide bioavailability(Up to 8 hours)
- Oxidative stress(Up to 8 hours)