Whole Milk vs Skim Milk for Insulin Resistance

(GOT MILC Trial)

Overseen By Bella Peña

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Lactose intolerance, Diabetes, Myocardial infarction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 4 months

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different types of milk—whole milk and skim milk—affect insulin resistance, a factor linked to heart disease. Participants will alternate between consuming only whole milk and only skim milk, tracking changes with a smartphone app. The goal is to determine if milk's fat content influences heart health and blood sugar control. Ideal participants are adults who drink at least a cup of milk most days, have a smartphone, and are comfortable using an app. As an unphased trial, this study allows participants to contribute to understanding dietary impacts on heart health and blood sugar control.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. However, if you plan to change your treatment for cholesterol, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that drinking whole milk can lower the risk of type 2 diabetes by 13% compared to low-fat milk. This suggests whole milk might be a safe option, especially for those concerned about diabetes.

Research also suggests that non-fat or skim milk can help the body manage sugar better without affecting weight or cholesterol levels, indicating that skim milk is generally safe for most people.

Both whole and skim milk have been linked to positive health effects, particularly in how the body handles sugar. Studies have not reported any major negative effects for either type of milk, so both appear to be well-tolerated by most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Whole Milk vs Skim Milk trial because it explores a unique dietary approach to managing insulin resistance, a condition typically addressed with medications like metformin or lifestyle changes such as diet and exercise. This trial is distinctive because it directly compares the effects of whole milk and skim milk consumption on insulin sensitivity, potentially offering a simple dietary modification as an alternative or complement to existing treatments. The use of an N-of-1 strategy with a mobile app for personalized guidance is another innovative feature, allowing for tailored dietary adjustments and real-time feedback. This approach could pave the way for more individualized, food-based interventions in managing insulin resistance.

What evidence suggests that this trial's treatments could be effective for insulin resistance?

This trial will compare the effects of whole milk and skim milk on insulin resistance. Participants will be randomized into two treatment sequences: one group will consume whole milk followed by skim milk, while the other group will consume skim milk followed by whole milk. Research has shown mixed results regarding the impact of whole milk and skim milk on insulin resistance. Some studies suggest that consuming a lot of dairy, including whole milk, might help with insulin resistance without affecting body weight or cholesterol levels. Other studies indicate that low-fat dairy, like skim milk, can also improve insulin sensitivity and lower the risk of type 2 diabetes. However, the effects can vary, and not all studies agree on which type of milk is better. Both types of milk offer potential benefits, but the evidence remains unclear on which is best for reducing insulin resistance. ^{5 6 7 8 9}

Who Is on the Research Team?

Gregory M Marcus, MD, MAS

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for adults over 18 who drink at least one cup of dairy milk daily, five days a week, and can use the Eureka mobile app. It's designed to see how different types of milk affect heart health and blood sugar control.

Inclusion Criteria

I can use the Eureka mobile app.

I drink at least one cup of dairy milk 5 days a week.

I am 18 years old or older.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to consume either whole milk or skim milk for two months, then crossover to the alternate milk type for another two months

4 months

Lab tests at 2 months and 4 months

Monitoring

Participants use a wrist-worn fitness tracker, Bluetooth-enabled scale, and blood pressure monitor to track health metrics weekly

4 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Skim Milk-Whole Milk
• Whole Milk-Skim Milk

Trial Overview Participants will switch between drinking whole milk and skim milk in a randomized order to compare the effects on their cholesterol levels and insulin resistance, which are important factors for heart disease.

How Is the Trial Designed?

Group I: Whole Milk-Skim Milk Experimental Treatment 1 Intervention

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.

Group II: Skim Milk-Whole Milk Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6769921/

The Effects of Dairy Intake on Insulin Resistance Our findings suggest that dairy intake, especially low-fat dairy products, has a beneficial effect on HOMA-IR, waist circumference, and body weight. This could ...

2. nutritionj.biomedcentral.com nutritionj.biomedcentral.com/articles/10.1186/1475-2891-12-56

Consumption of low-fat dairy foods for 6 months improves ... Study results suggest that high dairy consumption (4 servings/d) may improve insulin resistance without negatively impacting bodyweight or lipid status under ...

3. journals.lww.com journals.lww.com/cardiovascularendocrinology/fulltext/2025/03000/the_association_between_consumption_of_dairy.1.aspx

The association between consumption of dairy products ... Also, daily consumption of low-fat dairy products was associated with a 12% decrease in the risk of T2DM [15]. Furthermore, higher consumption of milk, yogurt, ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05464186?cond=diabetes

Effects of Whole vs. Nonfat Milk Consumption on Body ... Study Outcomes The primary outcome is change in fat mass measured by air displacement plethysmography (BodPod) at 3 time points (baseline and 6 and 12 months).

5. sciencedirect.com sciencedirect.com/science/article/pii/S2475299124024041

Dairy Intake in Relation to Prediabetes and Continuous ... This study aims to investigate the relationships between the intake of different dairy types, prediabetes risk, and continuous glycemic outcomes.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4325471/

Dairy Consumption and Insulin Resistance: The Role of ... The hyperinsulinemia resulting from milk and dairy consumption may be considered a beneficial and even protective effect for regulating blood glucose levels, ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0002916522006177

The impact of diets rich in low-fat or\ full-fat dairy on ... Both the low-fat and full-fat dairy diets decreased the Matsuda insulin sensitivity index (ISI) (means ± SDs −0.47 ± 1.07 and −0.25 ± 0.91, respectively) and as ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05464186?term=SKIM%20MILK&viewType=Table&rank=5

Effects of Whole vs. Nonfat Milk Consumption on Body ... This study will evaluate the effects of whole vs. nonfat milk consumption on body composition, cardiometabolic disease risk factors, and dietary quality.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12007357/

Association between non-skimmed milk consumption and ... Our findings indicate that frequent non-skimmed milk consumption is independently associated with an increased risk of MAFLD, even after ...