Milk for Diabetes Prevention
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if drinking milk can help prevent type 2 diabetes in individuals predisposed to lactose intolerance due to a specific genetic marker. Researchers will compare the effects of regular lactose-containing milk with lactose-free milk on blood sugar levels and gut health. Participants should have pre-diabetes (higher than normal blood sugar but not yet diabetes), consume a cup or less of milk daily, and be able to use a computer or smartphone. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could lead to new dietary recommendations for diabetes prevention.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot be on diabetes medication, antibiotics, probiotics, fiber supplements, laxatives, stool softeners, or anti-diarrheal medications. If you are taking probiotics, fiber supplements, laxatives, stool softeners, or anti-diarrheal medications, you must be able to stop taking them during the study.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that drinking milk, including regular milk with lactose, is generally safe for most people. Studies have found that consuming more milk, especially low-fat varieties, can lower the risk of developing type 2 diabetes. However, regular milk might cause digestive problems like bloating or diarrhea in those who are lactose intolerant.
The trial also includes lactose-free milk, designed for individuals who have trouble digesting lactose. While lactose-free milk can also help lower the risk of type 2 diabetes, some people might experience mild side effects, such as allergic reactions or stomach upset, though these are uncommon.
Overall, both types of milk are considered safe to drink. It's important to observe how your body reacts and consult a healthcare provider if any concerns arise before joining a trial.12345Why are researchers excited about this trial?
Unlike the standard diabetes prevention methods, which often focus on medications and lifestyle changes like diet and exercise, this study explores the potential of milk consumption—specifically lactose-containing and lactose-free milk—as a preventive measure. Researchers are excited because milk is a natural and widely consumed product that could offer an accessible and simple approach to diabetes prevention. The trial aims to determine if the type of milk consumed can influence diabetes risk, which could lead to new dietary recommendations that are easy to adopt and integrate into daily life.
What evidence suggests that this trial's treatments could be effective for diabetes prevention?
This trial will compare the effects of lactose-containing milk and lactose-free milk on diabetes prevention. Studies have shown that consuming milk and dairy products can lower the risk of developing type 2 diabetes. For those who are lactose intolerant, one recent study found that drinking just one cup of regular milk a day reduced the risk of type 2 diabetes by about 30%. This effect might occur because milk positively influences gut bacteria and related substances in the body. Research also suggests that lactose-free milk could benefit people with diabetes, as it usually causes smaller increases in blood sugar compared to regular milk. Additionally, each serving of low-lactose dairy may lower the risk of type 2 diabetes by up to 10%. Both types of milk could help manage blood sugar and reduce the risk of diabetes.24678
Who Is on the Research Team?
Brandilyn Peters-Samuelson, PhD
Principal Investigator
Albert Einstein College of Medicine
Are You a Good Fit for This Trial?
This trial is for adults with lactase non-persistence (genetic lactose intolerance) and pre-diabetes. Participants should be those who can still consume at least one cup of milk daily despite their intolerance.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Washout
Participants undergo a 2-week milk washout period with continuous glucose monitoring
Treatment
Participants are randomized to lactose-containing or lactose-free milk for 12 weeks, with increasing milk doses
Follow-up
Participants are monitored for safety and effectiveness after treatment, including a 2-week continuous glucose monitoring
What Are the Treatments Tested in This Trial?
Interventions
- Lactose-Containing Milk
- Lactose-Free Milk
Trial Overview
The study aims to compare the effects of drinking lactose-containing milk versus lactose-free milk on gut health and blood sugar control in people with genetic lactose intolerance and pre-diabetes.
How Is the Trial Designed?
2
Treatment groups
Active Control
Participants will be randomized to lactose-containing milk in strata of age (\<60, ≥60) and sex (female, male). Within each age and sex stratum, 10 participants will be randomized into two intervention groups in a 1:1 ratio
Participants will be randomized to lactose-free milk in strata of age (\<60, ≥60) and sex (female, male). Within each age and sex stratum, 10 participants will be randomized into two intervention groups in a 1:1 ratio
Find a Clinic Near You
Who Is Running the Clinical Trial?
Albert Einstein College of Medicine
Lead Sponsor
National Dairy Council
Collaborator
University of Minnesota (UM) Advanced Research and Diagnostic Laboratory (ARDL)
Collaborator
Published Research Related to This Trial
Citations
Study Details | NCT06513026 | Milk for Diabetes Prevention
lactose-free milk in LNP individuals with pre-diabetes, to comprehensively investigate the effects of milk intake on the gut microbiome and glycemic outcomes.
Associations between dairy foods, diabetes, and metabolic ...
Results from epidemiological studies generally support that consumption of milk and dairy products is associated with a lower incidence of T2D or improvements ...
Milk for Diabetes Prevention · Info for Participants
Research suggests that low-lactose milk may be suitable for diabetic diets because it causes a smaller increase in blood sugar levels compared to regular milk.
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.
Association between dairy consumption and the risk of diabetes
According to the RCS analysis, the risk of diabetes was reduced only with 25–65 g/day of dairy consumption in the total population. Similar to the results of a ...
Dairy consumption and risk of type-2 diabetes
It should be recognized that not all dairy products exhibit a beneficial role in preventing type-2 diabetes, except low-fat dairy foods, especially yogurt, ...
Effects of Milk and Dairy Product Consumption on Type 2 ...
Total dairy product consumption is associated with a lower risk of T2D, especially for yogurt and low-fat dairy consumption.
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dairynutrition.ca
dairynutrition.ca/en/nutrition-and-health/diabetes/milk-products-and-type-2-diabetesEvidence on Milk Products and Type 2 Diabetes
Current evidence indicates that higher consumption of milk products is associated with a reduced risk of developing type 2 diabetes.
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