Cardiovascular Disease, Heart Diseases
Conditions
Keywords
Cardiovascular Disease, Milk Fat, Milk, Dairy Products, Insulin Resistance, Hyperlipidemia
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALWhole Milk-Skim Milk
If randomized to the whole milk-skim milk treatment sequence, participants will be instructed to restrict their liquid milk consumption to only whole milk for the first 2 months and to only skim milk for the last 2 months of the enrollment period. Participants will receive weekly app and text-based message reminders of their randomization assignments.
BEHAVIORALSkim Milk-Whole Milk
If randomized to the skim milk-whole milk treatment sequence, participants will be instructed to restrict their liquid milk consumption to only skim milk for the first 2 months and to only whole milk for the last 2 months of the enrollment period. Participants will receive weekly app and text-based message reminders of their randomization assignments.
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1c (HbA1c) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean fasting lipid profile with whole fat milk compared to skim milk | Measured at 2 months and 4 months after intervention initiation | A secondary outcome will be mean fasting lipid profile with whole-fat milk compared to skim milk during the enrollment period. |
| Mean blood pressure with whole fat milk compared to skim milk | Measured weekly over the 4-month trial enrollment | Participants will receive weekly instruction via app or text-based messaging to utilize a Bluetooth blood pressure monitor in the morning prior to taking any medication. A secondary outcome will be mean diastolic, systolic, and mean blood pressure with whole-fat milk compared to skim milk. |
| Mean body weight with whole fat milk compared to skim milk | Measured weekly over the 4-month trial enrollment | Participants will receive weekly instruction via app or text-based messaging to utilize a Bluetooth scale in the morning prior to the first meal of the day. A secondary outcome will be mean body weight with whole-fat milk compared to skim milk. |
Countries
United States
Contacts
CONTACTGregory M Marcus, MD, MAS
CONTACTBella Peña
PRINCIPAL_INVESTIGATORGregory M Marcus, MD, MAS
University of California, San Francisco
Outcome results
None listed