Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
40 participants
INTERVENTIONAL
2026-02-28
2028-02-29
Brief Summary
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Detailed Description
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Specific aims of the study are to: (1) establish feasibility and tolerability of a randomized trial of lactose-containing vs. lactose-free milk; (2) to examine the effect of lactose-containing milk on gut microbiome species, functions, and metabolites in LNP individuals with pre-diabetes; and (3) to examine the effect of lactose-containing milk on glycemic outcomes in LNP individuals with pre-diabetes.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Lactose-Containing Milk
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
Lactose-Containing Milk
Participants will be asked to drink regular milk (1% or 2%) for 12 weeks as follows:
* Weeks 1-4: ½ cup milk per day
* Weeks 5-8: 1 cup milk per day
* Weeks 9-12: 2 cups milk per day
Participants will continue drinking 2 cups milk/day for 2 weeks after the 12-week follow-up visit.
Lactose-Free Milk
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
Lactose-Free Milk
Participants will be asked to drink 1% or 2% lactose-free milk for 12 weeks as follows:
* Weeks 1-4: ½ cup milk per day
* Weeks 5-8: 1 cup milk per day
* Weeks 9-12: 2 cups milk per day
Participants will continue drinking 2 cups milk/day for 2 weeks after the 12-week follow-up visit.
Interventions
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Lactose-Containing Milk
Participants will be asked to drink regular milk (1% or 2%) for 12 weeks as follows:
* Weeks 1-4: ½ cup milk per day
* Weeks 5-8: 1 cup milk per day
* Weeks 9-12: 2 cups milk per day
Participants will continue drinking 2 cups milk/day for 2 weeks after the 12-week follow-up visit.
Lactose-Free Milk
Participants will be asked to drink 1% or 2% lactose-free milk for 12 weeks as follows:
* Weeks 1-4: ½ cup milk per day
* Weeks 5-8: 1 cup milk per day
* Weeks 9-12: 2 cups milk per day
Participants will continue drinking 2 cups milk/day for 2 weeks after the 12-week follow-up visit.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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National Dairy Council
OTHER
University of Minnesota (UM) Advanced Research and Diagnostic Laboratory (ARDL)
UNKNOWN
Albert Einstein College of Medicine
OTHER
Responsible Party
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Principal Investigators
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Brandilyn Peters-Samuelson, PhD
Role: PRINCIPAL_INVESTIGATOR
Albert Einstein College of Medicine
Locations
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HCHS/SOL Bronx Field Center
The Bronx, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Role: primary
References
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Related Links
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R: A language and environment for statistical computing. R Foundation for Statistical Computing; 2021.
Other Identifiers
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2024-16045
Identifier Type: -
Identifier Source: org_study_id