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NCT Number: NCT07087184

Gauging Outcomes of Total Milk Ingestion on Lipid and gControl

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.

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Key information

Conditions

Heart Diseases Cardiovascular Disease Cardiovascular Diseases Dyslipidemias Glucose Metabolism Disorders Hyperinsulinism Hyperlipidemias Insulin Resistance Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCSF Medical Center at Parnassus

San Francisco, California, 94143, United States

Location status: Recruiting

Location contact

Gregory M Marcus, MD, MAS

CONTACT

[email protected]

415-476-5706

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Whole Milk-Skim Milk

Behavioral

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.

Skim Milk-Whole Milk

Behavioral

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.

Primary outcomes

  1. Hemoglobin A1c (HbA1c)

    Time frame: 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 outcomes

  1. Mean fasting lipid profile with whole fat milk compared to skim milk

    Time frame: 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.

  2. Mean blood pressure with whole fat milk compared to skim milk

    Time frame: 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.

  3. Mean body weight with whole fat milk compared to skim milk

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bella Peña

CONTACT

[email protected]

415-502-3053

Gregory M Marcus, MD, MAS

CONTACT

[email protected]

415-476-5706

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Acronym: GOT MILC

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 25, 2025
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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