Whole Milk Compared With Skimmed Milk and Effect on Lipids - A Randomized, Controlled Cross-over Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Fasting blood lipids
研究概览
简要总结
The aim of the project is to investigate the effects in humans of a daily intake of whole milk compared to skimmed milk primarily and secondarily respectively on:
- Blood lipids: total-, LDL-, and HDL-cholesterol and triglycerides
- Risk markers of diabetes type 2: plasma glucose and insulin
详细描述
This study will be a randomized controlled 2 x 3 weeks crossover intervention study with no wash-out period, as the lipids in the blood are known to adjust after 2 weeks. The effects of a diet containing 0.5 L of whole milk (17.5 g of milk fat/day) will be compared with a diet containing 0.5 L of skimmed milk (1.5 g of milk fat/day). Blinding is not possible since the appearance of the test foods cannot be concealed. The study subjects will receive the two test foods in random order, decided by draw of lots. Blood samples will be drawn on the first day of the period and in the end of the period for each 3 week-periods.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All subjects must give their informed consent in writing, after having received oral and written information about the study
- •Age: 20-70 y
- •BMI: 18.5 - 30 kg/m2
- •Healthy men and women (with no known diseases)
排除标准
- •Current or previous cardiovascular disease, high blood pressure or cholesterol
- •Diabetes Mellitus or other severe chronic disease, including severe allergies
- •Lactose intolerant or milk allergy
- •Use of dietary supplements two month prior to and during the intervention Blood donations 1 month prior to and during the intervention
- •Known or suspected abuse of alcohol, drugs or medication
- •Pregnant or are planning pregnancy during the study period
- •Extreme physical activity level (more than 10 hours tough physical activity pr. week)
- •Participation in other research studies
- •Inability, physically or mentally, to comply with the procedures required by the study protocol, as evaluated by the study staff
研究组 & 干预措施
Team 1: skimmed/whole
Milktype: 3 weeks with skimmed milk followed by 3 weeks with whole milk
干预措施: Milk type (Other)
Team 2: whole/skimmed
Milktype: 3 weeks with whole milk followed by 3 weeks with skimmed milk
干预措施: Milk type (Other)
结局指标
主要结局
Fasting blood lipids
时间窗: 3 weeks
total, LDL and HDL cholesterol and TAG
次要结局
- fasting plasma glucose(3 weeks)
- fasting serum insulin(3 weeks)
研究者
Arne Astrup
Professor
University of Copenhagen