Milk for Diabetes Prevention

Not yet recruiting at 1 trial location

Overseen By Brandilyn Peters-Samuelson, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Albert Einstein College of Medicine

Must not be taking: Diabetes medications, Antibiotics

Disqualifiers: Diabetes, Cancer, CVD, others

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

Compensation: Varies

Number of Visits: 7

Duration: 12 weeks

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. ^{1 2 3 4 5}

Why 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. ^{2 4 6 7 8}

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

Basic computer or smartphone skills

Drink ≤1 cup milk/day

My genetic test shows I have the GG genotype for lactose tolerance.

Exclusion Criteria

Not pregnant or breastfeeding

I haven't taken antibiotics in the last 3 months.

I do not have cancer, heart disease, or any life-threatening illness.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Washout

Participants undergo a 2-week milk washout period with continuous glucose monitoring

2 weeks

1 visit (in-person)

Treatment

Participants are randomized to lactose-containing or lactose-free milk for 12 weeks, with increasing milk doses

12 weeks

4 visits (in-person) for tests and sample collection

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a 2-week continuous glucose monitoring

2 weeks

1 visit (in-person)

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?

Group I: Lactose-Containing Milk Active Control 1 Intervention

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

Group II: Lactose-Free Milk Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Albert Einstein College of Medicine

Lead Sponsor

Trials

302

Recruited

11,690,000+

National Dairy Council

Collaborator

Trials

20

Recruited

1,800+

Published Research Related to This Trial

In a study with 16 lactose-intolerant subjects, low-lactose milk resulted in significantly fewer symptoms compared to regular milk, indicating it is a safer option for those with lactose intolerance.

A second group of 17 subjects showed a clear link between the amount of lactose consumed and the severity of symptoms, suggesting that low-lactose milk allows for greater consumption without adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Symptom response to lactose-reduced milk in lactose-intolerant adults. Jones, DV., Latham, MC., Kosikowski, FV., et al.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06513026

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.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5367265/

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 ...

3. withpower.com withpower.com/trial/phase-lactose-intolerance-7-2024-73861

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.

4. 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.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9550167/

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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8026335/

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, ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2161831322002071

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.

8. dairynutrition.ca dairynutrition.ca/en/nutrition-and-health/diabetes/milk-products-and-type-2-diabetes

Evidence 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.