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Milk may ward off diabetes in Lactose-Intolerant individuals

NCT ID NCT06513026

Prevention Sponsor: Albert Einstein College of Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether drinking regular milk can lower the risk of type 2 diabetes in people with lactose intolerance who also have pre-diabetes. Researchers will compare regular milk to lactose-free milk over 12 weeks in 40 adults. They will measure changes in gut bacteria, blood sugar levels, and digestive symptoms.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Lactose-containing milk
What this could lead to
If it works, this could point toward a simple dietary approach to reduce type 2 diabetes risk in people with lactose intolerance.
What could go wrong
This is a very small, early-stage trial with only 40 participants. The results may not apply to everyone, and drinking milk could cause digestive discomfort.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion 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 recent study visit \[for HCHS/SOL participant\] or most recent medical chart or self-report \[for other participant\]) * Drink ≤1 cup milk/day * Basic computer or smartphone skills * Can speak and read English fluently Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

glucose intolerance lactose intolerance prediabetes syndrome type 2 diabetes mellitus prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes mellitus type 2 Lactase persistence Lactose intolerance Lactose intolerant Pre diabetes

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • HCHS/SOL Bronx Field Center

    RECRUITING

    The Bronx, New York, 10458, United States

    Contact Email: •••••@•••••

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