Recruiting

High-Fat vs. Non-Fat

Sponsor:

UCLA

Code:

NCT07087184

Conditions

Heart Diseases

Cardiovascular Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Whole Milk-Skim Milk

Skim Milk-Whole Milk

Study Details

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.

Conditions

Heart Diseases

Cardiovascular Disease

Study ID

NCT07087184

Start date

Jul 24, 2025

Status verified date

Jul, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

110 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

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.

Primary outcome measure

  • Hemoglobin A1c (HbA1c) [ Time Frame: Measured at 2 months and 4 months after intervention initiation ]

Central Contacts and Locations

Central contacts

Gregory M Marcus, MD, MAS

415-476-5706greg.marcus@ucsf.edu

Bella Peña

415-502-3053bella.pena@ucsf.edu

Locations

UCSF Medical Center at Parnassus

Recruiting

San Francisco, California, United States, 94143

Contacts

Gregory M Marcus, MD, MAS

415-476-5706greg.marcus@ucsf.edu

More Information

Sponsor

University of California, San Francisco

Last update posted

Jul 22, 2026

Last verified

Jul, 2026

Keywords

  • Cardiovascular Disease
  • Milk Fat
  • Milk
  • Dairy Products
  • Insulin Resistance
  • Hyperlipidemia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-07-22.