No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 70
Sex
Any
Study type
Interventional
Purpose
Prevention
Participants needed
40 (estimated)
Sponsor
Albert Einstein College of Medicine · Other
Who this trial is looking for
This trial is looking for adults with lactose intolerance who have pre-diabetes. Participants will drink either lactose-containing milk or lactose-free milk to help understand how milk affects their blood sugar and gut health.
Are You a Good Fit for This Trial?
You may be able to join if
I have a specific genetic type that causes lactose intolerance.
I have a history of pre-diabetes.
I drink 1 cup or less of milk each day.
I can use a computer or smartphone.
I can speak and read English fluently.
You may not be able to join if
I have been diagnosed with diabetes.
I take medication for diabetes.
I have cancer or heart disease.
I have a known milk allergy.
I have severe stomach problems after drinking milk.
I have had stomach surgery.
I smoke.
I am pregnant or breastfeeding.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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)…
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.
Trial Locations
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Eligibility Criteria
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 …
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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