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Search / Trial NCT06513026

Milk for Diabetes Prevention

Launched by ALBERT EINSTEIN COLLEGE OF MEDICINE · Jul 19, 2024

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Lactose Lactose Free Lactase Non Persistence

ClinConnect Summary

The "Milk for Diabetes Prevention" clinical trial is studying how drinking milk might affect people with lactose intolerance who are at risk for developing type 2 diabetes. Researchers want to find out if drinking regular milk, compared to lactose-free milk, can improve health outcomes related to blood sugar levels and gut health in individuals who have a specific genetic marker that makes them lactose intolerant. Previous studies suggested that those who consume a cup of milk each day had a lower risk of type 2 diabetes, and this trial aims to explore this connection further.

To participate in this trial, you must be at least 18 years old, have a certain genetic marker indicating lactose intolerance, and have a history of pre-diabetes (a condition where blood sugar levels are higher than normal but not high enough to be classified as diabetes). You should also currently drink no more than one cup of milk per day. Participants will be asked to drink either regular or lactose-free milk over the course of the study, and researchers will monitor how this affects their blood sugar and gut health. This study is not yet recruiting, so if you or someone you know might be interested, stay tuned for more information.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Age ≥18
  • LNP genotype (LCT gene rs4988235, GG genotype)
  • History of pre-diabetes, defined as fasting blood glucose 100-125 mg/dL and/or hemoglobin A1c (HbA1c) 5.7-6.4% and have not been diagnosed with diabetes nor take diabetes medication. If blood test over 3 years ago, pre-diabetes will be confirmed using finger-stick HbA1c.
  • Drink ≤1 cup milk/day
  • Basic computer or smartphone skills
  • English or Spanish speaking
  • Exclusion Criteria:
  • Diabetes diagnosis
  • Taking anti-diabetes medication
  • Blood test with history of pre-diabetes conducted \>3 years ago and finger-stick HbA1c is normal (≤5.6%).
  • Cancer, cardiovascular disease (CVD), or life-threatening illness
  • Known milk allergy
  • Has severe GI symptoms after drinking milk
  • History of GI surgery
  • Smoking
  • ≤1 alcoholic beverage/day
  • Pregnant or breastfeeding
  • Colonoscopy in last 2 weeks
  • Antibiotics in last 3 months
  • Taking probiotics or fiber supplements (if taking, must be able to stop taking during study)
  • Taking laxatives, stool softeners, anti-diarrheals (if taking, must be able to stop taking during study)
  • Participating in any extreme dieting programs

About Albert Einstein College Of Medicine

Albert Einstein College of Medicine is a leading academic institution dedicated to advancing biomedical research and medical education. Situated in the Bronx, New York, it is renowned for its commitment to innovative research and training the next generation of physicians and scientists. The college actively engages in a wide range of clinical trials, focusing on translating scientific discoveries into effective therapies and improving patient care. With a collaborative approach that involves multidisciplinary teams, Albert Einstein College of Medicine aims to address significant health challenges and contribute to the global medical community through rigorous research and evidence-based practices.

Locations

Bronx, New York, United States

Patients applied

0 patients applied

Trial Officials

Brandilyn Peters-Samuelson, PhD

Principal Investigator

Albert Einstein College of Medicine

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported