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Mätande resultat av totalt intag av mjölk på lipid och gcontrol (GOT MILC)

30 september 2026 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

110

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

  • Förenta staterna
    • California
      • San Francisco, California, Förenta staterna, 94143
        • Rekrytering
        • UCSF Medical Center at Parnassus
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

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
  • Are pregnant or plan on getting pregnant
  • Unable to read or sign to provide informed consent

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Crossover tilldelning
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Beteende: 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.
Experimentell: 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.
Beteende: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Hemoglobin A1c (HbA1c)
Tidsram: 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.
Measured at 2 months and 4 months after intervention initiation

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Mean fasting lipid profile with whole fat milk compared to skim milk
Tidsram: 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.
Measured at 2 months and 4 months after intervention initiation
Mean blood pressure with whole fat milk compared to skim milk
Tidsram: 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.
Measured weekly over the 4-month trial enrollment
Mean body weight with whole fat milk compared to skim milk
Tidsram: 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.
Measured weekly over the 4-month trial enrollment

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of California, San Francisco

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

24 juli 2025

Primärt slutförande (Beräknad)

1 juni 2027

Avslutad studie (Beräknad)

1 augusti 2027

Studieregistreringsdatum

Först inskickad

18 juli 2025

Först inskickad som uppfyllde QC-kriterierna

18 juli 2025

Första postat (Faktisk)

25 juli 2025

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

2 oktober 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

30 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 25-44169

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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