The InterSat Study: Interesterified Fats: Health Effects of Commercially Relevant Palmitic Versus Stearic Acid Rich Interesterified Fats
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 4
- 主要终点
- Change from baseline in fasting total:HDL cholesterol ratio
研究概览
简要总结
In response to the removal of trans fats from our foods, the food industry now uses interesterified (IE) fats. Randomly interesterified (IE) fats rich in palmitic (Europe) and stearic (North America) acids are the most commonly used IE fats by the food industry. Despite their widespread use, there has been no published research on the acute and chronic cardio-metabolic health effects of the most commonly consumed palmitic and stearic acid rich IE fats. The aim of InterSat is to investigate the postprandial and chronic effects of a diet rich in IE fats on cardiometabolic health.
详细描述
Choice of design: A randomised crossover study with two arms, each arm consisting of a 6-week dietary intervention, separated by a 3-week (minimum) washout period.
Study population: Healthy adult snackers aged 35-65 years. 48 participants in total, 24 at each centre (see Locations).
Locations:
Metabolic Research Unit, Franklin-Wilkins Building, Waterloo Campus, King College London.
Metabolic Research Unit Maastricht, Academic Hospital Maastricht, Maastricht University.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy (free of diagnosed diseases listed in exclusion criteria).
- •Able to give informed consent.
- •Able to give informed consent.
- •Accessible veins on arms as determined by examination at screening
排除标准
- •Having a medical condition or history which might impact study measurements, to be judged by the study physician (e.g. myocardial infarction, angina, thrombosis, stroke, cancer, liver or bowel disease or diabetes)
- •Use of plant-sterol/stanol-enriched foods or supplements in the three months prior to the screening and/or during the study
- •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
- •Full blood count (FBC), liver function out of healthy range
- •Blood pressure ≥140/90 mmHg
- •Current use of antihypertensive or lipid lowering medications
- •Use of over-the-counter and prescribed medication, which may interfere with study measurements (to be judged by the principal investigator)
- •Alcohol intake exceeding a moderate intake (> 21 units per week)
- •Current cigarette smoker (or quit within last 6 months)
- •≥ 20% 10-year risk of cardiovascular disease (CVD) as calculated using a risk calculator
- •Active blood donor or plans to donate blood within 6 months of study completion
- •Use of oral antibiotics (with the exception of topical antibiotics) in 40 days or less prior to the start of the study
- •Reported weight loss or gain of 3 kg or more during a period of 2 months prior to screening
- •Reported dietary habits: medically prescribed diet, allergy/intolerance to test products that will be provided during the study
- •Reported participation in another nutritional or biomedical trial 3 months prior to screening
- •Reported participation in night shift work 2 weeks prior to screening and/or during the study. Night work is defined as working between midnight and 6.00 am Anyone who has given blood in the last 3 months
结局指标
主要结局
Change from baseline in fasting total:HDL cholesterol ratio
时间窗: 6 weeks
Total to high-density lipoprotein (Total:HDL) cholesterol ratio
次要结局
- Change from baseline in fasting Lp(a)(6 weeks)
- Change from baseline in plasma total fatty acid composition(6 weeks)
- Change from baseline in fasting glucose(6 weeks)
- Change from baseline in fasting LDL cholesterol(6 weeks)
- Endothelial function(Fasting, 270 min and 450 min following consumption of breakfast containing IE fats)
- Postprandial glucose homeostasis (Incremental area under the curve (iAUC) 0-240 min and 0-480 min)(Fasting, 30 min, 60 min, 120 min, 180 min, 240 min, 300 min, 360 min, 420 min, 480 min following consumption of breakfast containing IE fats.)
- Fasting Insulin sensitivity(Fasting, 30 min, 60 min, 120 min, 180 min, 240 min, 300 min, 360 min, 420 min, 480 min following consumption of breakfast containing IE fats.)
- Change from baseline in fasting insulin(6 weeks)
- Postprandial lipaemia(Fasting, 60 min, 120 min, 180 min, 240 min, 300 min, 360 min, 420 min, 480 min following consumption of breakfast containing IE fats.)
- Change from baseline in fasting total cholesterol(6 weeks)
- Change from baseline in fasting apoB(6 weeks)
- Change from baseline in liver fat (Maastricht only)(6 weeks)
- Change from baseline in fasting apoA1(6 weeks)