Milk for Diabetes Prevention

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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

Individuals with lactase non-persistence (LNP; determined by a functional variant in the LCT gene \[rs4988235, GG genotype\]) are susceptible to lactose intolerance in adulthood due to deficiency of lactase, the enzyme which digests milk lactose sugars. However, many LNP individuals still drink ≥1 cup of milk daily. Recent analysis in the Hispanic Community Health Study/Study of Latinos (HCHS/SOL) found that consumption of 1 serving (cup) of milk/day was associated with \~30% lower risk of type 2 diabetes among LNP individuals, but not among individuals with lactase persistence (LP). This beneficial effect might be partially explained by favorable alterations in gut microbiota and related metabolites associated with higher milk consumption among LNP individuals. Based on these observational study findings, the investigator team proposes to conduct a randomized, controlled trial of lactose-containing vs. lactose-free milk in LNP individuals with pre-diabetes, to comprehensively investigate the effects of milk intake on the gut microbiome and glycemic outcomes.

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.

What data supports the effectiveness of the treatment Lactose-Containing Milk and Lactose-Free Milk for diabetes prevention?

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. This could help manage blood sugar levels in people with diabetes, potentially supporting its use in diabetes prevention. ^{1 2 3 4 5}

Is milk safe for human consumption, especially for those with lactose intolerance or diabetes?

Research suggests that both regular and low-lactose milk are generally safe for human consumption. Low-lactose milk may cause fewer symptoms in lactose-intolerant individuals and may be suitable for diabetic diets due to its lower impact on blood sugar levels. ^{1 2 3 4 6}

How does the treatment of lactose-containing and lactose-free milk differ from other diabetes treatments?

This treatment is unique because it explores the use of lactose-containing and lactose-free milk to manage blood sugar levels, which is different from standard diabetes treatments that typically involve medications or insulin. The study suggests that low-lactose milk may be suitable for diabetic diets due to its lower impact on blood sugar levels compared to regular milk. ^{1 2 3 5 7}

Research Team

Brandilyn Peters-Samuelson, PhD

Principal Investigator

Albert Einstein College of Medicine

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Symptom response to lactose-reduced milk in lactose-intolerant adults. [2018]

2. Germany pubmed.ncbi.nlm.nih.gov

Blood glucose and plasma insulin responses to fat-free milk and low-lactose fat-free milk in young type 1 diabetics. [2019]

3. Germany pubmed.ncbi.nlm.nih.gov

Blood glucose and plasma insulin responses to fat free milk and low-lactose fat free milk in healthy human volunteers. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Lactose malabsorption and tolerance of lactose-hydrolyzed milk. A double-blind controlled crossover study. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Utilization of a low-lactose milk. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Lactose-free milk for infants with acute gastroenteritis in a developing country: study protocol for a randomized controlled trial. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Effects of energy source in milk replacer on glucose metabolism of neonatal dairy calves. [2021]