Gauging Outcomes of Total Milk Ingestion on Lipid and gControl

Overview

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.

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

Interventions

• 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.
• 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.

Primary outcome measures

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

Secondary outcome measures (3)

• Mean fasting lipid profile with whole fat milk compared to skim milk [Time frame: Measured at 2 months and 4 months after intervention initiation]
• Mean blood pressure with whole fat milk compared to skim milk [Time frame: Measured weekly over the 4-month trial enrollment]
• Mean body weight with whole fat milk compared to skim milk [Time frame: Measured weekly over the 4-month trial enrollment]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Prevention

Study locations

United States · 1 center

• UCSF Medical Center at Parnassus — San Francisco

Publications

• 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
• 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
• 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
• 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
• 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
• 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, An PMID 30217460
• 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 PMID 38264914
• 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

Identifiers

NCT: NCT07087184 · 25-44169

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗