Lactose IntoleranceNCT06513026
Milk for Diabetes Prevention
A study testing Lactose-Containing Milk and Lactose-Free Milk in people with Lactose Intolerance and Lactose Intolerant, run by Albert Einstein College of Medicine at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lactose Intolerance, Lactose Intolerant, Lactase Persistence
- What is being tested?
- Lactose-Containing Milk and Lactose-Free Milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2026to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
HCHS/SOL Bronx Field Center
The Bronx, New York, 10458
718-584-1563, milkstudy@einsteinmed.edu
About this study
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.
Read the detailed description
The trial will feature a 2-week milk washout period, followed by 1:1 randomization to lactose-containing (1% or 2%) or lactose-free (1% or 2%) milk for 12 weeks (4 weeks each of ½ cup, 1 cup, and 2 cups milk). Before and after the 12 weeks, visits will entail lactose challenge hydrogen breath tests (HBT; i.e., lactose tolerance tests) and blood tests for fasting glucose, hemoglobin A1c, and metabolomics; while stool samples and continuous glucose monitoring (CGM) data will be collected at home using provided kits/devices.
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
- Lactose Intolerance, Lactose Intolerant, Lactase Persistence, Pre-Diabetes, Diabetes Mellitus, Type 2
- Being tested
- Lactose-Containing Milk, Lactose-Free Milk
- Keywords
- Lactose, Lactose-free, Lactase Non Persistence
- Medical subject headings
- Lactose Intolerance, Glucose Intolerance, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactose-Containing MilkDietary supplement
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 MilkDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Lactose-Containing Milk | Active comparator | 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 Receives: Dietary Supplement: Lactose-Containing Milk |
| Lactose-Free Milk | Active comparator | 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 Receives: Dietary Supplement: Lactose-Free Milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal symptoms
Gastrointestinal symptoms, specifically abdominal pain, bloating, flatulence, and diarrhea, will be recorded daily from screening visit through 12 weeks of milk intervention. The occurrence and severity of these four adverse events will be summarized and reported by study arm. Average frequencies of none-mild vs. moderate-severe symptoms will be compared between treatment groups by week of study, as well as for specific time intervals corresponding to milk doses (weeks 1-4, 5-8, 9-12).
Measured: Daily From Screening visit to Week 12
Change in Expired Breath Hydrogen
Expired breath hydrogen after lactose challenge will be measured during the baseline visit and after 12 weeks of milk intervention at the time of the follow-up visit using Hydrogen Breath Test (HBT) kits. Breath tubes will be mailed to an external laboratory where stable isotope analysis for expired breath hydrogen will be conducted. Expired breath hydrogen will be expressed as incremental Area Under the Curve (iAUC). Change in iAUC from baseline to week 12 will be summarized using basic descriptive statistics (group means and standard deviations), and change in iAUC will be compared between treatment groups.
Measured: From Baseline to Week 12
Change in gut microbiome features - Relative Abundance of Species
Stool samples will be collected using home stool microbiome kits at baseline, 4-, 8-, and 12-week timepoints. Shotgun sequencing will be conducted. Change in relative abundance of species (with >1% mean relative abundance) from baseline will summarized, using basic descriptive statistics (group means and standard deviations). Change in relative abundance of species from baseline will be compared between the treatment groups.
Measured: From Baseline to Week 12
Change in gut microbiome features - Functional Pathway Relative Abundance
Stool samples will be collected using home stool microbiome kits at baseline, 4-, 8-, and 12-week timepoints. Shotgun sequencing will be conducted. Change in relative abundance of functional pathways (with >1% mean relative abundance) from baseline will summarized, using basic descriptive statistics (group means and standard deviations). Change in relative abundance of functional pathways from baseline will be compared between the treatment groups.
Measured: From Baseline to Week 12
Change in gut microbiome features - Metabolomics
Targeted metabolic profiling will be performed on serum and stool samples (baseline and week 12) using LC-MS/MS methods for absolute quantitation of 70 metabolites associated with gut bacterial metabolism. Change in stool and serum metabolites from baseline will be summarized using basic descriptive statistics (group means and standard deviations). Change in stool and serum metabolites from baseline will be compared between the treatment groups.
Measured: From Baseline to Week 12
Change in glycemic outcomes - Fasting glucose
Blood sera samples for fasting glucose will be collected at baseline and Week 12. Fasting glucose, i.e., blood sugar levels following an 8-hour fast, will be analyzed via standard analytical chemistry approaches and reported in mg/dL or mmol/L units. Ranges vary but a fasting glucose level <99 mg/dL is considered 'normal', between 100-125 mg/dL is within the 'pre-diabetic' range, >126 mg/dL is within the 'diabetic' range. Change in fasting glucose from baseline will be summarized using descriptive statistics (means and standard deviations) and compared between the treatment groups.
Measured: From Baseline to Week 12
Change in glycemic outcomes - Hemoglobin A1c (HbA1c)
Whole blood samples for HbA1c will be collected at baseline and Week 12. HbA1c, used to measure the amount of hemoglobin with attached glucose and reflects average blood glucose levels over the past several months, will be analyzed via standard analytical chemistry approaches. Ranges vary, however, a 'normal' HbA1c is generally <5.7%, 5.7-6.4% is in the 'pre-diabetic' range and a value of 6.5% or greater is in the 'diabetic' range. Change in HbA1c from baseline will be summarized using descriptive statistics (means and standard deviations) and compared between the treatment groups.
Measured: From Baseline to Week 12
Change in glycemic outcomes - Continuous Glucose Monitoring (CGM) mean glucose
During screening visit participants will have a 2-week continuous glucose monitor (CGM) applied to the skin on the upper arm in advance of the 2-week milk washout period. The CGM will be returned during the baseline visit 2 weeks later. After the 12 week visit, another 2-week CGM will be applied during which time participants will continue drinking milk concurrent with the 2-week CGM (i.e., until 14 weeks). Change in mean glucose (mg/dL) from screening to week 14 will be summarized using descriptive statistics (means and standard deviations) and compared between the treatment groups.
Measured: From Screening visit to Week 14 visit
Change in glycemic outcomes - Continuous Glucose Monitoring (CGM) glycemic variability
During screening visit participants will have a 2-week continuous glucose monitor (CGM) applied to the skin on the upper arm in advance of the 2-week milk washout period. The CGM will be returned during the baseline visit 2 weeks later. After the 12 week visit, another 2-week CGM will be applied during which time participants will continue drinking milk concurrent with the 2-week CGM (i.e., until 14 weeks). Change in glycemic variability (%CV) from screening to week 14 will be summarized using descriptive statistics (means and standard deviations) and compared between the treatment groups.
Measured: From Screening visit to Week 14 visit
Change in glycemic outcomes - Continuous Glucose Monitoring (CGM) time above range
During screening visit participants will have a 2-week continuous glucose monitor (CGM) applied to the skin on the upper arm in advance of the 2-week milk washout period. The CGM will be returned during the baseline visit 2 weeks later. After the 12 week visit, another 2-week CGM will be applied during which time participants will continue drinking milk concurrent with the 2-week CGM (i.e., until 14 weeks). Change in time above range (%) from screening to week 14 will be summarized using descriptive statistics (means and standard deviations) and compared between the treatment groups.
Measured: From Screening visit to Week 14 visit
Change in glycemic outcomes - Continuous Glucose Monitoring (CGM) time in range
During screening visit participants will have a 2-week continuous glucose monitor (CGM) applied to the skin on the upper arm in advance of the 2-week milk washout period. The CGM will be returned during the baseline visit 2 weeks later. After the 12 week visit, another 2-week CGM will be applied during which time participants will continue drinking milk concurrent with the 2-week CGM (i.e., until 14 weeks). Change in time in range (%) from screening to week 14 will be summarized using descriptive statistics (means and standard deviations) and compared between the treatment groups.
Measured: From Screening visit to Week 14 visit
Change in glycemic outcomes - Continuous Glucose Monitoring (CGM) time below range
During screening visit participants will have a 2-week continuous glucose monitor (CGM) applied to the skin on the upper arm in advance of the 2-week milk washout period. The CGM will be returned during the baseline visit 2 weeks later. After the 12 week visit, another 2-week CGM will be applied during which time participants will continue drinking milk concurrent with the 2-week CGM (i.e., until 14 weeks). Change in time below range (%) from screening to week 14 will be summarized using descriptive statistics (means and standard deviations) and compared between the treatment groups.
Measured: From Screening visit to Week 14 visit
Change in Flatulence
The Smart Underwear device will be worn externally on regular underwear near the rectum/perineum during specified daytime wear periods. The device continuously detects hydrogen in expelled flatus and records supporting temperature and movement data. These data will be used to derive the frequency of flatus events per wear period, which reflects intestinal gas production and gut microbial activity. De-identified data will be transferred after each wear period through the Human Flatus Atlas mobile app and uploaded to servers. Change in frequency of flatus events per wear period will be summarized using basic descriptive statistics (group means and standard deviations).
Measured: From Screening to Week 1, from Week 1 to Week 10, and from Week 1 to Week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start15 May 2026
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for Lactose IntoleranceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Dairy Council, University of Minnesota (UM) Advanced Research and Diagnostic Laboratory (ARDL), Azenta Life Sciences, Metabolic Solutions Inc.
- Responsible party
- Sponsor
- Investigators
- Brandilyn Peters-Samuelson, PhD, Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06513026
- Sponsor's protocol ID
- 2024-16045
- Status last verified
- May 2026
- First submitted
- 16 Jul 2024
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saeedi P, Petersohn I, Salpea P, Malanda B, Karuranga S, Unwin N, Colagiuri S, Guariguata L, Motala AA, Ogurtsova K, Shaw JE, Bright D, Williams R; IDF Diabetes Atlas Committee. Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: Results from the International Diabetes Federation Diabetes Atlas, 9th edition. Diabetes Res Clin Pract. 2019 Nov;157:107843. doi: 10.1016/j.diabres.2019.107843. Epub 2019 Sep 10.
PubMed 31518657GBD 2019 Diseases and Injuries Collaborators. Global burden of 369 diseases and injuries in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2020 Oct 17;396(10258):1204-1222. doi: 10.1016/S0140-6736(20)30925-9.
PubMed 33069326Parker ED, Lin J, Mahoney T, Ume N, Yang G, Gabbay RA, ElSayed NA, Bannuru RR. Economic Costs of Diabetes in the U.S. in 2022. Diabetes Care. 2024 Jan 1;47(1):26-43. doi: 10.2337/dci23-0085.
PubMed 37909353Uusitupa M, Khan TA, Viguiliouk E, Kahleova H, Rivellese AA, Hermansen K, Pfeiffer A, Thanopoulou A, Salas-Salvado J, Schwab U, Sievenpiper JL. Prevention of Type 2 Diabetes by Lifestyle Changes: A Systematic Review and Meta-Analysis. Nutrients. 2019 Nov 1;11(11):2611. doi: 10.3390/nu11112611.
PubMed 31683759Wareham NJ. Personalised prevention of type 2 diabetes. Diabetologia. 2022 Nov;65(11):1796-1803. doi: 10.1007/s00125-022-05774-7. Epub 2022 Aug 2.
PubMed 35916901Liu B, Sun Y, Bao W. Creating and supporting a healthy food environment for type 2 diabetes prevention. Lancet Planet Health. 2018 Oct;2(10):e423-e424. doi: 10.1016/S2542-5196(18)30211-0. No abstract available.
PubMed 30318098Aune D, Norat T, Romundstad P, Vatten LJ. Dairy products and the risk of type 2 diabetes: a systematic review and dose-response meta-analysis of cohort studies. Am J Clin Nutr. 2013 Oct;98(4):1066-83. doi: 10.3945/ajcn.113.059030. Epub 2013 Aug 14.
PubMed 23945722Luo K, Chen GC, Zhang Y, Moon JY, Xing J, Peters BA, Usyk M, Wang Z, Hu G, Li J, Selvin E, Rebholz CM, Wang T, Isasi CR, Yu B, Knight R, Boerwinkle E, Burk RD, Kaplan RC, Qi Q. Variant of the lactase LCT gene explains association between milk intake and incident type 2 diabetes. Nat Metab. 2024 Jan;6(1):169-186. doi: 10.1038/s42255-023-00961-1. Epub 2024 Jan 22.
PubMed 38253929Segurel L, Bon C. On the Evolution of Lactase Persistence in Humans. Annu Rev Genomics Hum Genet. 2017 Aug 31;18:297-319. doi: 10.1146/annurev-genom-091416-035340. Epub 2017 Apr 19.
PubMed 28426286Storhaug CL, Fosse SK, Fadnes LT. Country, regional, and global estimates for lactose malabsorption in adults: a systematic review and meta-analysis. Lancet Gastroenterol Hepatol. 2017 Oct;2(10):738-746. doi: 10.1016/S2468-1253(17)30154-1. Epub 2017 Jul 7.
PubMed 28690131Anguita-Ruiz A, Aguilera CM, Gil A. Genetics of Lactose Intolerance: An Updated Review and Online Interactive World Maps of Phenotype and Genotype Frequencies. Nutrients. 2020 Sep 3;12(9):2689. doi: 10.3390/nu12092689.
PubMed 32899182Robles L, Priefer R. Lactose Intolerance: What Your Breath Can Tell You. Diagnostics (Basel). 2020 Jun 17;10(6):412. doi: 10.3390/diagnostics10060412.
PubMed 32560312Wilt TJ, Shaukat A, Shamliyan T, Taylor BC, MacDonald R, Tacklind J, Rutks I, Schwarzenberg SJ, Kane RL, Levitt M. Lactose intolerance and health. Evid Rep Technol Assess (Full Rep). 2010 Feb;(192):1-410.
PubMed 20629478JanssenDuijghuijsen L, Looijesteijn E, van den Belt M, Gerhard B, Ziegler M, Ariens R, Tjoelker R, Geurts J. Changes in gut microbiota and lactose intolerance symptoms before and after daily lactose supplementation in individuals with the lactase nonpersistent genotype. Am J Clin Nutr. 2024 Mar;119(3):702-710. doi: 10.1016/j.ajcnut.2023.12.016. Epub 2023 Dec 28.
PubMed 38159728Carroccio A, Montalto G, Cavera G, Notarbatolo A. Lactose intolerance and self-reported milk intolerance: relationship with lactose maldigestion and nutrient intake. Lactase Deficiency Study Group. J Am Coll Nutr. 1998 Dec;17(6):631-6. doi: 10.1080/07315724.1998.10718813.
PubMed 9853544
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Milk for Diabetes Prevention
- ClinicalTrials.gov ID
- NCT06513026
- Acronym / sponsor ID
- 2024-16045
- Conditions
- Lactose Intolerance, Lactose Intolerant, Lactase Persistence, Pre-Diabetes, Diabetes Mellitus, Type 2
- Keywords
- Lactose, Lactose-free, Lactase Non Persistence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Collaborators
- National Dairy Council, University of Minnesota (UM) Advanced Research and Diagnostic Laboratory (ARDL), Azenta Life Sciences, Metabolic Solutions Inc.
- Study start
- 15 May 2026 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 22 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The trial will feature a 2-week milk washout period, followed by 1:1 randomization to lactose-containing (1% or 2%) or lactose-free (1% or 2%) milk for 12 weeks (4 weeks each of ½ cup, 1 cup, and 2 cups milk). Before and after the 12 weeks, visits will entail lactose challenge hydrogen breath tests (HBT; i.e., lactose tolerance tests) and blood tests for fasting glucose, hemoglobin A1c, and metabolomics; while stool samples and continuous glucose monitoring (CGM) data will be collected at home using provided kits/devices.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactose-Containing Milk | Active comparator | Dietary Supplement: Lactose-Containing MilkParticipants 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-Free Milk | Active comparator | Dietary Supplement: Lactose-Free MilkParticipants 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (18 listed)
- Diabetes diagnosis
- Taking anti-diabetes medication
- Cancer, cardiovascular disease (CVD), or life-threatening illness
- Known milk allergy
- Has severe GI symptoms after drinking milk
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactose-Containing MilkParticipants 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. | Dietary supplement | Lactose-Containing Milk |
| Lactose-Free MilkParticipants 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. | Dietary supplement | Lactose-Free Milk |
Primary outcome
Gastrointestinal symptoms
Time frame: Daily From Screening visit to Week 12
Gastrointestinal symptoms, specifically abdominal pain, bloating, flatulence, and diarrhea, will be recorded daily from screening visit through 12 weeks of milk intervention. The occurrence and severity of these four adverse events will be summarized and reported by study arm. Average frequencies of none-mild vs. moderate-severe symptoms will be compared between treatment groups by week of study, as well as for specific time intervals corresponding to milk doses (weeks 1-4, 5-8, 9-12).
Change in Expired Breath Hydrogen
Time frame: From Baseline to Week 12
Expired breath hydrogen after lactose challenge will be measured during the baseline visit and after 12 weeks of milk intervention at the time of the follow-up visit using Hydrogen Breath Test (HBT) kits. Breath tubes will be mailed to an external laboratory where stable isotope analysis for expired breath hydrogen will be conducted. Expired breath hydrogen will be expressed as incremental Area Under the Curve (iAUC). Change in iAUC from baseline to week 12 will be summarized using basic descriptive statistics (group means and standard deviations), and change in iAUC will be compared between treatment groups.
Change in gut microbiome features - Relative Abundance of Species
Time frame: From Baseline to Week 12
Stool samples will be collected using home stool microbiome kits at baseline, 4-, 8-, and 12-week timepoints. Shotgun sequencing will be conducted. Change in relative abundance of species (with >1% mean relative abundance) from baseline will summarized, using basic descriptive statistics (group means and standard deviations). Change in relative abundance of species from baseline will be compared between the treatment groups.
Change in gut microbiome features - Functional Pathway Relative Abundance
Time frame: From Baseline to Week 12
Stool samples will be collected using home stool microbiome kits at baseline, 4-, 8-, and 12-week timepoints. Shotgun sequencing will be conducted. Change in relative abundance of functional pathways (with >1% mean relative abundance) from baseline will summarized, using basic descriptive statistics (group means and standard deviations). Change in relative abundance of functional pathways from baseline will be compared between the treatment groups.
Change in gut microbiome features - Metabolomics
Time frame: From Baseline to Week 12
Targeted metabolic profiling will be performed on serum and stool samples (baseline and week 12) using LC-MS/MS methods for absolute quantitation of 70 metabolites associated with gut bacterial metabolism. Change in stool and serum metabolites from baseline will be summarized using basic descriptive statistics (group means and standard deviations). Change in stool and serum metabolites from baseline will be compared between the treatment groups.
Change in glycemic outcomes - Fasting glucose
Time frame: From Baseline to Week 12
Blood sera samples for fasting glucose will be collected at baseline and Week 12. Fasting glucose, i.e., blood sugar levels following an 8-hour fast, will be analyzed via standard analytical chemistry approaches and reported in mg/dL or mmol/L units. Ranges vary but a fasting glucose level <99 mg/dL is considered 'normal', between 100-125 mg/dL is within the 'pre-diabetic' range, >126 mg/dL is within the 'diabetic' range. Change in fasting glucose from baseline will be summarized using descriptive statistics (means and standard deviations) and compared between the treatment groups.
Change in glycemic outcomes - Hemoglobin A1c (HbA1c)
Time frame: From Baseline to Week 12
Whole blood samples for HbA1c will be collected at baseline and Week 12. HbA1c, used to measure the amount of hemoglobin with attached glucose and reflects average blood glucose levels over the past several months, will be analyzed via standard analytical chemistry approaches. Ranges vary, however, a 'normal' HbA1c is generally <5.7%, 5.7-6.4% is in the 'pre-diabetic' range and a value of 6.5% or greater is in the 'diabetic' range. Change in HbA1c from baseline will be summarized using descriptive statistics (means and standard deviations) and compared between the treatment groups.
Change in glycemic outcomes - Continuous Glucose Monitoring (CGM) mean glucose
Time frame: From Screening visit to Week 14 visit
During screening visit participants will have a 2-week continuous glucose monitor (CGM) applied to the skin on the upper arm in advance of the 2-week milk washout period. The CGM will be returned during the baseline visit 2 weeks later. After the 12 week visit, another 2-week CGM will be applied during which time participants will continue drinking milk concurrent with the 2-week CGM (i.e., until 14 weeks). Change in mean glucose (mg/dL) from screening to week 14 will be summarized using descriptive statistics (means and standard deviations) and compared between the treatment groups.
Change in glycemic outcomes - Continuous Glucose Monitoring (CGM) glycemic variability
Time frame: From Screening visit to Week 14 visit
During screening visit participants will have a 2-week continuous glucose monitor (CGM) applied to the skin on the upper arm in advance of the 2-week milk washout period. The CGM will be returned during the baseline visit 2 weeks later. After the 12 week visit, another 2-week CGM will be applied during which time participants will continue drinking milk concurrent with the 2-week CGM (i.e., until 14 weeks). Change in glycemic variability (%CV) from screening to week 14 will be summarized using descriptive statistics (means and standard deviations) and compared between the treatment groups.
Change in glycemic outcomes - Continuous Glucose Monitoring (CGM) time above range
Time frame: From Screening visit to Week 14 visit
During screening visit participants will have a 2-week continuous glucose monitor (CGM) applied to the skin on the upper arm in advance of the 2-week milk washout period. The CGM will be returned during the baseline visit 2 weeks later. After the 12 week visit, another 2-week CGM will be applied during which time participants will continue drinking milk concurrent with the 2-week CGM (i.e., until 14 weeks). Change in time above range (%) from screening to week 14 will be summarized using descriptive statistics (means and standard deviations) and compared between the treatment groups.
Change in glycemic outcomes - Continuous Glucose Monitoring (CGM) time in range
Time frame: From Screening visit to Week 14 visit
During screening visit participants will have a 2-week continuous glucose monitor (CGM) applied to the skin on the upper arm in advance of the 2-week milk washout period. The CGM will be returned during the baseline visit 2 weeks later. After the 12 week visit, another 2-week CGM will be applied during which time participants will continue drinking milk concurrent with the 2-week CGM (i.e., until 14 weeks). Change in time in range (%) from screening to week 14 will be summarized using descriptive statistics (means and standard deviations) and compared between the treatment groups.
Change in glycemic outcomes - Continuous Glucose Monitoring (CGM) time below range
Time frame: From Screening visit to Week 14 visit
During screening visit participants will have a 2-week continuous glucose monitor (CGM) applied to the skin on the upper arm in advance of the 2-week milk washout period. The CGM will be returned during the baseline visit 2 weeks later. After the 12 week visit, another 2-week CGM will be applied during which time participants will continue drinking milk concurrent with the 2-week CGM (i.e., until 14 weeks). Change in time below range (%) from screening to week 14 will be summarized using descriptive statistics (means and standard deviations) and compared between the treatment groups.
Change in Flatulence
Time frame: From Screening to Week 1, from Week 1 to Week 10, and from Week 1 to Week 14
The Smart Underwear device will be worn externally on regular underwear near the rectum/perineum during specified daytime wear periods. The device continuously detects hydrogen in expelled flatus and records supporting temperature and movement data. These data will be used to derive the frequency of flatus events per wear period, which reflects intestinal gas production and gut microbial activity. De-identified data will be transferred after each wear period through the Human Flatus Atlas mobile app and uploaded to servers. Change in frequency of flatus events per wear period will be summarized using basic descriptive statistics (group means and standard deviations).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Background: PubMed 31518657Saeedi P, Petersohn I, Salpea P, Malanda B, Karuranga S, Unwin N, Colagiuri S, Guariguata L, Motala AA, Ogurtsova K, Shaw JE, Bright D, Williams R; IDF Diabetes Atlas Committee. Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: Results from the International Diabetes Federation Diabetes Atlas, 9th edition. Diabetes Res Clin Pract. 2019 Nov;157:107843. doi: 10.1016/j.diabres.2019.107843. Epub 2019 Sep 10.
- Background: PubMed 33069326GBD 2019 Diseases and Injuries Collaborators. Global burden of 369 diseases and injuries in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2020 Oct 17;396(10258):1204-1222. doi: 10.1016/S0140-6736(20)30925-9.
- Background: PubMed 37909353Parker ED, Lin J, Mahoney T, Ume N, Yang G, Gabbay RA, ElSayed NA, Bannuru RR. Economic Costs of Diabetes in the U.S. in 2022. Diabetes Care. 2024 Jan 1;47(1):26-43. doi: 10.2337/dci23-0085.
- Background: PubMed 31683759Uusitupa M, Khan TA, Viguiliouk E, Kahleova H, Rivellese AA, Hermansen K, Pfeiffer A, Thanopoulou A, Salas-Salvado J, Schwab U, Sievenpiper JL. Prevention of Type 2 Diabetes by Lifestyle Changes: A Systematic Review and Meta-Analysis. Nutrients. 2019 Nov 1;11(11):2611. doi: 10.3390/nu11112611.
- Background: PubMed 35916901Wareham NJ. Personalised prevention of type 2 diabetes. Diabetologia. 2022 Nov;65(11):1796-1803. doi: 10.1007/s00125-022-05774-7. Epub 2022 Aug 2.
- Background: PubMed 30318098Liu B, Sun Y, Bao W. Creating and supporting a healthy food environment for type 2 diabetes prevention. Lancet Planet Health. 2018 Oct;2(10):e423-e424. doi: 10.1016/S2542-5196(18)30211-0. No abstract available.
- Background: PubMed 23945722Aune D, Norat T, Romundstad P, Vatten LJ. Dairy products and the risk of type 2 diabetes: a systematic review and dose-response meta-analysis of cohort studies. Am J Clin Nutr. 2013 Oct;98(4):1066-83. doi: 10.3945/ajcn.113.059030. Epub 2013 Aug 14.
- Background: PubMed 38253929Luo K, Chen GC, Zhang Y, Moon JY, Xing J, Peters BA, Usyk M, Wang Z, Hu G, Li J, Selvin E, Rebholz CM, Wang T, Isasi CR, Yu B, Knight R, Boerwinkle E, Burk RD, Kaplan RC, Qi Q. Variant of the lactase LCT gene explains association between milk intake and incident type 2 diabetes. Nat Metab. 2024 Jan;6(1):169-186. doi: 10.1038/s42255-023-00961-1. Epub 2024 Jan 22.
- Background: PubMed 28426286Segurel L, Bon C. On the Evolution of Lactase Persistence in Humans. Annu Rev Genomics Hum Genet. 2017 Aug 31;18:297-319. doi: 10.1146/annurev-genom-091416-035340. Epub 2017 Apr 19.
- Background: PubMed 28690131Storhaug CL, Fosse SK, Fadnes LT. Country, regional, and global estimates for lactose malabsorption in adults: a systematic review and meta-analysis. Lancet Gastroenterol Hepatol. 2017 Oct;2(10):738-746. doi: 10.1016/S2468-1253(17)30154-1. Epub 2017 Jul 7.
- Background: PubMed 32899182Anguita-Ruiz A, Aguilera CM, Gil A. Genetics of Lactose Intolerance: An Updated Review and Online Interactive World Maps of Phenotype and Genotype Frequencies. Nutrients. 2020 Sep 3;12(9):2689. doi: 10.3390/nu12092689.
- Background: PubMed 32560312Robles L, Priefer R. Lactose Intolerance: What Your Breath Can Tell You. Diagnostics (Basel). 2020 Jun 17;10(6):412. doi: 10.3390/diagnostics10060412.
- R: A language and environment for statistical computing. R Foundation for Statistical Computing; 2021.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brandilyn Peters-Samuelson, PhD principal investigator
Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactose-Containing Milk and Lactose-Free Milk in people with Lactose Intolerance and Lactose Intolerant, run by Albert Einstein College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brandilyn Peters-Samuelson, PhD (718-430-3281, brandilyn.peterssamuelson@einsteinmed.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastrointestinal symptoms (time frame: Daily From Screening visit to Week 12). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06513026, which also lists 38 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.