Impact of Low Fat Milk Intake on Cardiovascular Risk Indicators in Children 6-13 Years of Age
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 650
- 试验地点
- 1
- 主要终点
- Cardiovascular risk indicators
研究概览
简要总结
Substituting whole milk intake for defatted milk will improve indicators of cardiovascular risk, i.e. total cholesterol, triglycerides, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL)cholesterol, apolipoproteins: ApoB100, Lp(a) and ApoA in a sample of Mexican children 6-13 years of age.
详细描述
Double blind trial in 600 children 6-13 years of age residing in 12 boarding schools. Schools will be randomized to distribute three types of milk namely: full fat milk (3% fat), partially defatted milk (2% fat) or defatted milk (1% fat) for 90 days of effective exposure (4 months total duration). Subjects will receive 400 mL of the corresponding milk every day (200 mL breakfast and 200 mL night meal) from Monday through Friday. During week ends they will eat a freely chosen diet at home. Milk intake will be measured every day. Diet by 24 h-recall. will be evaluated every month. Blood samples will be obtained at the beginning and at the end of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Attending selected boarding schools
排除标准
- •No lactose intolerance
结局指标
主要结局
Cardiovascular risk indicators
时间窗: 4 months
Cardiovascular risk is indicated by several determinations of blood fats namely: Total cholesterol, triglicerides, Low-density lipoprotein (LDL) and High density lipoprotein (HDL) cholesterol, lipoproteins: Apo a1,Apo B100 and Lp(a)
次要结局
未报告次要终点