Effect of Cheese on Cardiovascular Risk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- LDL cholesterol
研究概览
简要总结
The main objective of the current study is to examine whether a high intake of regular-fat cheeses (Danbo and Cheddar) affect blood lipids differently than an isocaloric intake of either other fatty animal food products or of starchy carbohydrates. Furthermore, effects on fat digestibility, blood pressure, anthropometry, bile acid metabolism and insulin sensitivity is investigated.
To do this, a randomized crossover intervention study with 3x14 days full diet periods (cheese diet, meat diet or carb diet)will be conducted in 16 postmenopausal women. Between the diet periods there will be at least 14 days of wash-out where the subjects eat their habitual diets. Fasting blood samples will be drawn before and after the diet periods, and also a non-fasting blood sample will be drawn after the diet periods. Furthermore, total feces is collected the last 5 days of each diet period.
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
- None
入排标准
- 年龄范围
- 45 Years 至 68 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female gender
- •Postmenopausal for >1 year
- •Age 45-68 years
- •BMI 25-32 kg/m2
- •TC > 4.5 mmol/L and < 7 mmol/L
- •Systolic blood pressure <160 mmHg and/or diastolic blood pressure <100 mmHg
排除标准
- •Chronic diseases (known diabetes; CVD; other chronic diseases which could affect the results of the present study)
- •Milk allergy
- •Nut allergy
- •Use of dietary supplements incl. multivitamins (2 months before and during the entire study period)
- •Elite athletes (>10 hours of strenuous physical activity per week)
- •Use of prescription medicine which could affect the results of the present study including systemic glucocorticoids
- •Use of lipid-lowering agents
- •Stable dose of antihypertensive medication >3 months before study commencement for subjects with high blood pressure
- •Hormone replacement therapy
- •Blood donation <1 month before study commencement and during study period
- •Simultaneous participation in other clinical studies
- •Inability (physically or psychologically) to comply with the procedures required by the protocol
结局指标
主要结局
LDL cholesterol
时间窗: day 1 and day 14 in each diet period
fasting, mmol/l
次要结局
- Dietary fat digestibility(During day 10-14 in each period)
- Bile acid metabolism(day 14 of each intervention period)
- Blood pressure(day 1 and day 14 in each diet period)
- ApoA1 and ApoB(day 1 and day 14 in each diet period)
- Anthropometry(day 1 and day 14 in each diet period)
- Blood lipid concentrations(day 1 and day 14 in each diet period)
- Insulin sensitivity(day 1 and 14 in each diet period)
研究者
Arne Astrup
Prof., MD, Head of Department, Department of Nutrition, Exercise and Sports
University of Copenhagen