Gauging Outcomes of Total Milk Ingestion on Lipid and gControl
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Non-English speaker
Are lactose intolerant
History of myocardial infarction
History of type I or type II diabetes
Trial design
Design model
Crossover
Treatments tested in this trial
Whole Milk-Skim Milk
BehavioralIf 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.
Skim Milk-Whole Milk
BehavioralIf 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.
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: Whole Milk-Skim MilkExperimental treatment 1 intervention
Group B: Skim Milk-Whole MilkExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Hemoglobin A1c (HbA1c)
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.
Time frame
Measured at 2 months and 4 months after intervention initiationSecondary outcomes
1
Mean fasting lipid profile with whole fat milk compared to skim milk
A secondary outcome will be mean fasting lipid profile with whole-fat milk compared to skim milk during the enrollment period.
Time frame
Measured at 2 months and 4 months after intervention initiation2
Mean blood pressure with whole fat milk compared to skim milk
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.
Time frame
Measured weekly over the 4-month trial enrollment3
Mean body weight with whole fat milk compared to skim milk
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.
Time frame
Measured weekly over the 4-month trial enrollmentSponsors and contacts
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Source ClinicalTrials.gov