Milk for Diabetes Prevention Study
This study is looking at whether drinking milk can help prevent type 2 diabetes in people who have pre-diabetes and are also lactose intolerant (meaning their body has trouble digesting milk sugars). We are testing two types of milk: lactose-containing milk and lactose-free milk. Participants will gradually increase their milk intake over 12 weeks, starting with half a cup per day and ending with two cups per day. We will be looking at how milk affects your gut health, including your gut bacteria (microbiome), and your blood sugar levels. To join, you need to be between 18 and 70 years old, have a specific genetic marker for lactose intolerance (LNP genotype), and have pre-diabetes. The study aims to enroll 40 participants, but its current status is unclear.
- Study design
- This is an interventional study where 40 participants will be randomly assigned to drink either lactose-containing milk or lactose-free milk for 12 weeks.
- What's involved
- You would have a 2-week milk washout period, then drink milk daily for 12 weeks, gradually increasing the amount. You will also have visits for breath tests and blood tests, and collect stool samples and continuous glucose monitoring (CGM) data at home.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will continue drinking milk for 2 weeks after the 12-week follow-up visit. Gastrointestinal symptoms will be measured daily from screening to week 12, and changes in breath hydrogen and gut microbiome features will be measured from baseline to week 12.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Milk for Diabetes Prevention
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Brandilyn Peters-Samuelson, PhD · PRINCIPAL_INVESTIGATOR · Albert Einstein College of Medicine
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Inclusion
Exclusion
What this trial measures
- Gastrointestinal symptomsDaily 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 HydrogenFrom 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 SpeciesFrom 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 AbundanceFrom 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 - MetabolomicsFrom 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 glucoseFrom 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)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 glucoseFrom 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 variabilityFrom 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 rangeFrom 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 rangeFrom 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 rangeFrom 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 FlatulenceFrom 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).