The Acute Effects of Interesterification of Commercially Used Fats on Postprandial Fat Metabolism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Area under plasma TAG concentration/ time curve
研究概览
简要总结
The purpose of this study is to investigate whether there are differences in postprandial metabolic indices following interesterified fats used commercially versus the corresponding un-interesterified blend.
详细描述
Aim: The current study aims to investigate the acute effects of commercially relevant interesterified 'hardstock' versus the corresponding un-interesterified blend on 8 h postprandial fat metabolism.
Hypothesis
Interesterification of a palm kernel and palm stearin fat blend, to produce a fat with a higher proportion of palmitic acid in the middle position of the triglyceride (TAG; but the same fatty acid composition), will alter postprandial lipid metabolism.
Subjects: Participants will include 24 healthy male and female (postmenopausal) volunteers aged between the ages of 45 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 10 males and 10 females is required to detect a (clinically relevant) difference (for males and females separately) between means of 0.3 mmol/L maximal difference in 8 h plasma TAG concentration (standard deviation 0.33 mmol/L, significance level (alpha) of 0.05 and 80% power). 12 males and 12 females will be recruited to allow for a 20% drop out 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
- 45 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 45-75 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
- •Premenopausal (for women)
- •Alcohol intake exceeding a moderate intake (> 28 units per week)
- •Current cigarette smoker (or quit withint the last 6 months)
- •≥ 20% 10-year risk of CVD as calculated using a risk calculator
结局指标
主要结局
Area under plasma TAG concentration/ time curve
时间窗: Up to 8 hours
Postprandial area under plasma TAG concentration/ time curve
次要结局
- Positional composition retention (chylomicron)(Up to 6 hours)
- Postprandial lipaemic response(Up to 8 hours)