Lactose Intolerance study: Lactose-Containing Milk vs Lactose-Free Milk
Official title Milk for Diabetes Prevention
ClinicalTrials.gov ID: NCT06513026
What this study is testing
- What it's testing
- This study is testing whether drinking regular milk versus lactose‑free milk changes blood sugar and gut bacteria in people with pre‑diabetes who have a lactase‑deficiency gene.
- Who it's for
- You may be able to join if you have pre‑diabetes, are an adult, and have the lactase‑non‑persistence gene.
- What's involved
- You will be picked by chance, like a coin toss, to drink one cup of regular milk or lactose‑free milk each day. You will give stool and blood samples at the start and later check‑ins.
- Time commitment
- The study lasts several months with visits at the start, middle, and end.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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...
- Drink ≤1 cup milk/day
- Basic computer or smartphone skills
- Can speak and read English fluently
You likely can't join if
- Diabetes diagnosis
- Taking anti-diabetes medication
- Cancer, cardiovascular disease (CVD), or life-threatening illness
- Known milk allergy
- Has severe GI symptoms after drinking milk
- History of GI surgery
See the full eligibility criteria
- 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 (pre-diabetes determined at most...
- Drink ≤1 cup milk/day
- Basic computer or smartphone skills
- Can speak and read English fluently
- Diabetes diagnosis
- Taking anti-diabetes medication
- Cancer, cardiovascular disease (CVD), or life-threatening illness
- Known milk allergy
- Has severe GI symptoms after drinking milk
- History of GI surgery
- Had a double mastectomy
- Smoking
- More than 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-diarrheal (if taking, must be able to stop taking during study)
- Taking lactase pills (if taking, must be able to stop taking)
- Participating in extreme dieting program
- Planning extended travel that would prevent participation in study
- Taking medication that must be taken separate from calcium or dairy products
The study team makes the final eligibility decision.
Where it is enrolling
- The Bronx, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at The Bronx, New York, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.