Gauging Outcomes of Total Milk Ingestion on Lipid and gControl (GOT MILC)

October 22, 2025 updated by: University of California, San Francisco
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 100 participants will be enrolled for participation in this clinical trial.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • Recruiting
        • UCSF Medical Center at Parnassus
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: Whole 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.
Experimental: 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.
Behavioral: Skim 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in hemoglobin A1c (HbA1c)
Time Frame: 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.
Measured at 2 months and 4 months after intervention initiation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in 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 a change in fasting lipid profile with whole-fat milk compared to skim milk during the enrollment period.
Measured at 2 months and 4 months after intervention initiation
Change in 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 a change in body weight with whole-fat milk compared to skim milk.
Measured weekly over the 4-month trial enrollment
Change in 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 a change in diastolic, systolic, and mean blood pressure with whole-fat milk compared to skim milk.
Measured weekly over the 4-month trial enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Gregory M Marcus, MD, MAS, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 24, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

July 18, 2025

First Submitted That Met QC Criteria

July 18, 2025

First Posted (Actual)

July 25, 2025

Study Record Updates

Last Update Posted (Estimated)

October 24, 2025

Last Update Submitted That Met QC Criteria

October 22, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-44169

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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