Gauging Outcomes of Total Milk Ingestion on Lipid and gControl

NCT07087184 | Recruiting

• 1 other identifier: 25-44169
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

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.

  Measured at 2 months and 4 months after intervention initiation

Secondary Outcomes (3)

• Mean fasting lipid profile with whole fat milk compared to skim milk

  Measured at 2 months and 4 months after intervention initiation

• Mean blood pressure with whole fat milk compared to skim milk

  Measured weekly over the 4-month trial enrollment

• Mean body weight with whole fat milk compared to skim milk

  Measured weekly over the 4-month trial enrollment

Study Arms (2)

Whole Milk-Skim Milk

EXPERIMENTAL

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

Skim Milk-Whole Milk

EXPERIMENTAL

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

Interventions

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.

Whole Milk-Skim Milk

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.

Skim Milk-Whole Milk

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF Medical Center at Parnassus

San Francisco, California, 94143, United States

RECRUITING

Related Publications (10)

• Hoyt G, Hickey MS, Cordain L. Dissociation of the glycaemic and insulinaemic responses to whole and skimmed milk. Br J Nutr. 2005 Feb;93(2):175-7. doi: 10.1079/bjn20041304.

  PMID: 15788109 BACKGROUND

• Drouin-Chartier JP, Cote JA, Labonte ME, Brassard D, Tessier-Grenier M, Desroches S, Couture P, Lamarche B. Comprehensive Review of the Impact of Dairy Foods and Dairy Fat on Cardiometabolic Risk. Adv Nutr. 2016 Nov 15;7(6):1041-1051. doi: 10.3945/an.115.011619. Print 2016 Nov.

  PMID: 28140322 BACKGROUND

• Astrup A, Magkos F, Bier DM, Brenna JT, de Oliveira Otto MC, Hill JO, King JC, Mente A, Ordovas JM, Volek JS, Yusuf S, Krauss RM. Saturated Fats and Health: A Reassessment and Proposal for Food-Based Recommendations: JACC State-of-the-Art Review. J Am Coll Cardiol. 2020 Aug 18;76(7):844-857. doi: 10.1016/j.jacc.2020.05.077. Epub 2020 Jun 17.

  PMID: 32562735 BACKGROUND

• Aune D, Norat T, Romundstad P, Vatten LJ. Dairy products and the risk of type 2 diabetes: a systematic review and dose-response meta-analysis of cohort studies. Am J Clin Nutr. 2013 Oct;98(4):1066-83. doi: 10.3945/ajcn.113.059030. Epub 2013 Aug 14.

  PMID: 23945722 BACKGROUND

• Pereira MA, Jacobs DR Jr, Van Horn L, Slattery ML, Kartashov AI, Ludwig DS. Dairy consumption, obesity, and the insulin resistance syndrome in young adults: the CARDIA Study. JAMA. 2002 Apr 24;287(16):2081-9. doi: 10.1001/jama.287.16.2081.

  PMID: 11966382 BACKGROUND

• Dehghan M, Mente A, Rangarajan S, Sheridan P, Mohan V, Iqbal R, Gupta R, Lear S, Wentzel-Viljoen E, Avezum A, Lopez-Jaramillo P, Mony P, Varma RP, Kumar R, Chifamba J, Alhabib KF, Mohammadifard N, Oguz A, Lanas F, Rozanska D, Bostrom KB, Yusoff K, Tsolkile LP, Dans A, Yusufali A, Orlandini A, Poirier P, Khatib R, Hu B, Wei L, Yin L, Deeraili A, Yeates K, Yusuf R, Ismail N, Mozaffarian D, Teo K, Anand SS, Yusuf S; Prospective Urban Rural Epidemiology (PURE) study investigators. Association of dairy intake with cardiovascular disease and mortality in 21 countries from five continents (PURE): a prospective cohort study. Lancet. 2018 Nov 24;392(10161):2288-2297. doi: 10.1016/S0140-6736(18)31812-9. Epub 2018 Sep 11.

  PMID: 30217460 BACKGROUND

• Martin SS, Aday AW, Almarzooq ZI, Anderson CAM, Arora P, Avery CL, Baker-Smith CM, Barone Gibbs B, Beaton AZ, Boehme AK, Commodore-Mensah Y, Currie ME, Elkind MSV, Evenson KR, Generoso G, Heard DG, Hiremath S, Johansen MC, Kalani R, Kazi DS, Ko D, Liu J, Magnani JW, Michos ED, Mussolino ME, Navaneethan SD, Parikh NI, Perman SM, Poudel R, Rezk-Hanna M, Roth GA, Shah NS, St-Onge MP, Thacker EL, Tsao CW, Urbut SM, Van Spall HGC, Voeks JH, Wang NY, Wong ND, Wong SS, Yaffe K, Palaniappan LP; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. 2024 Heart Disease and Stroke Statistics: A Report of US and Global Data From the American Heart Association. Circulation. 2024 Feb 20;149(8):e347-e913. doi: 10.1161/CIR.0000000000001209. Epub 2024 Jan 24.

  PMID: 38264914 BACKGROUND

• Lanou AJ, Barnard ND. Dairy and weight loss hypothesis: an evaluation of the clinical trials. Nutr Rev. 2008 May;66(5):272-9. doi: 10.1111/j.1753-4887.2008.00032.x.

  PMID: 18454813 BACKGROUND

• Thorning TK, Raben A, Tholstrup T, Soedamah-Muthu SS, Givens I, Astrup A. Milk and dairy products: good or bad for human health? An assessment of the totality of scientific evidence. Food Nutr Res. 2016 Nov 22;60:32527. doi: 10.3402/fnr.v60.32527. eCollection 2016.

  PMID: 27882862 BACKGROUND

• U.S. Department of Agriculture and U.S. Department of Health and Human Services. Dietary Guidelines for Americans, 2020-2025. 9th Edition. December 2020. Available at DietaryGuidelines.gov.

  BACKGROUND

MeSH Terms

Conditions

Heart Diseases; Cardiovascular Diseases; Insulin Resistance; Hyperlipidemias

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Dyslipidemias; Lipid Metabolism Disorders

Study Officials

• Gregory M Marcus, MD, MAS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gregory M Marcus, MD, MAS

CONTACT

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

Bella Peña

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2025
• First Posted: July 25, 2025
• Study Start: July 24, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)