Gauging Outcomes of Total Milk Ingestion on Lipid and gControl
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Difference in hemoglobin A1c (HbA1c)
研究概览
简要总结
Atherosclerotic cardiovascular disease remains the leading cause of death for adults in the United States. The cardiovascular impact of milk consumption remains a matter of long-standing scientific debate. Current guidelines for Americans recommend three daily servings of fat-free or low-fat (1%) dairy over full-fat options due to concerns that saturated fat may increase cardiovascular risk. Yet, the literature does not consistently support non-fat dairy as superior to high-fat dairy for reducing cardiometabolic risk. Identifying the comparative health benefits of non-fat versus high-fat dairy milk would be immediately applicable to patients who seek cardiovascular care. In this randomized, case-crossover trial, the investigators seek to efficiently assess the association between high-fat versus non-fat dairy milk consumption and insulin resistance. Utilizing the Eureka Platform, participants will be randomized to limit their liquid milk consumption to whole milk followed by skim milk (or vice versa), measuring the effect of milk fat content on glycemic index and lipid profile.
详细描述
The study is designed as an N of 1 randomized trial, where each participant will be randomized to consume high-fat versus non-fat dairy milk then crossover to the alternate condition over two consecutive two-month periods. After two and four months, participants will have lab tests performed, including hemoglobin A1c (HbA1c) and fasting lipids. Throughout the study, participants will be instructed to continuously wear a wrist-worn fitness tracker, use a Bluetooth-enabled scale and blood pressure monitor to trend weight and blood pressure weekly, and utilize the Eureka mobile application for self-monitoring of dairy milk consumption, diet, lifestyle, and physical activity. Aside from study-related dairy milk instructions, all other aspects of diet will remain constant throughout study participation. The study seeks to elucidate the relationship between dairy milk consumption and overall health. A total of 110 participants will be enrolled for participation in this clinical trial.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are age ≥18 years
- •Have a smartphone
- •Are able to use the Eureka mobile application
- •Consume, on average, at least one cup of dairy milk daily, at least 5 days per week
排除标准
- •Non-English speaker
- •Are lactose intolerant
- •History of myocardial infarction
- •History of type I or type II diabetes
- •Familial hypercholesterolemia
- •Plan to change treatment for cholesterol
- •Unable to read or sign to provide informed consent
研究组 & 干预措施
Whole Milk-Skim Milk
Participants randomized to the whole milk-skim milk treatment sequence will be instructed to limit their liquid milk consumption to only whole milk during the first two months of the study (Month 1-2), followed by only non-fat milk during the final two months of the study (Month 3-4). Using an N-of-1 strategy delivered by the National Institutes of Health (NIH)-funded, University of California, San Francisco (UCSF)-run Eureka platform utilizing a mobile smartphone-based application, subjects will be instructed weekly via app and text-based messaging on the type of liquid milk (whole or non-fat) to consume.
干预措施: Whole Milk-Skim Milk (Behavioral)
Skim Milk-Whole Milk
Participants randomized to the skim milk-whole milk treatment sequence will be instructed to limit their liquid milk consumption to only non-fat milk during the first two months of the study (Month 1-2), followed by only whole-fat milk during the final two months of the study (Month 3-4). Using an N-of-1 strategy delivered by the National Institutes of Health (NIH)-funded, University of California, San Francisco (UCSF)-run Eureka platform utilizing a mobile smartphone-based application, subjects will be instructed weekly via app and text-based messaging on the type of liquid milk (whole or non-fat) to consume.
干预措施: Skim Milk-Whole Milk (Behavioral)
结局指标
主要结局
Difference in hemoglobin A1c (HbA1c)
时间窗: Measured at 2 months and 4 months after intervention initiation
The primary outcome will be a difference in hemoglobin A1c (HbA1c) with whole-fat milk compared to skim milk during the enrollment period.
Hemoglobin A1c (HbA1c)
时间窗: Measured at 2 months and 4 months after intervention initiation
The primary outcome will be the hemoglobin A1c (HbA1c) measured at the end of each intervention period with whole-fat milk compared to skim milk during the enrollment period.
次要结局
- Change in fasting lipid profile with whole-fat milk compared to skim milk(Measured at 2 months and 4 months after intervention initiation)
- Change in blood pressure with whole-fat milk compared to skim milk(Measured weekly over the 4-month trial enrollment)
- Change in body weight with whole-fat milk compared to skim milk(Measured weekly over the 4-month trial enrollment)
- Change in fasting lipid profile with whole-fat milk compared to skim milk(Measured at 2 months and 4 months after intervention initiation)
- Change in blood pressure with whole-fat milk compared to skim milk(Measured weekly over the 4-month trial enrollment)
- Change in body weight with whole-fat milk compared to skim milk(Measured weekly over the 4-month trial enrollment)
- Mean fasting lipid profile with whole fat milk compared to skim milk(Measured at 2 months and 4 months after intervention initiation)
- Mean blood pressure with whole fat milk compared to skim milk(Measured weekly over the 4-month trial enrollment)
- Mean body weight with whole fat milk compared to skim milk(Measured weekly over the 4-month trial enrollment)