Postprandial Glucose ResponseNCT07567443
A1-Free vs. Conventional Milk Metabolic Response Study
A study testing Lactose-Containing A1-Free Milk, Lactose-Containing Conventional Milk and Lactose-Free A1-Free Milk With Delayed Lactose Drink in people with Postprandial Glucose Response and Insulin Response, run by Purdue University.
Trial summary
This study will examine how different types of milk affect blood sugar and insulin responses after eating. Specifically, the study compares milk that contains only A2 beta-casein protein (A1-free milk) to conventional milk, which contains both A1 and A2 proteins. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postprandial Glucose Response, Insulin Response, Lactose Digestion
- What is being tested?
- Lactose-Containing A1-Free Milk, Lactose-Containing Conventional Milk and Lactose-Free A1-Free Milk With Delayed Lactose Drink
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2026to 31 Jan 2027
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability/desire to provide informed consent
- Are between 18 and 65 years of age
- Are generally healthy, with no known metabolic or gastrointestinal conditions that would affect digestion or metabolism
- Are willing to consume milk-based beverages and lactose-containing drinks as part of the study
- Are willing to fast overnight (approximately 10-12 hours) prior to study visits and follow study instructions (e.g., diet and activity restrictions)
- Are willing to attend all study visits and complete all study procedures (blood draws, breath tests, urine samples, questionnaires)
- Are able to understand and provide written informed consent in English.
Who cannot join
- You have a known allergy to milk or dairy products
- You are currently pregnant, planning to become pregnant, or breastfeeding
- You currently smoke or have used tobacco or nicotine-containing products within the past 3 months
- You have a history of excessive alcohol use within the past 30 days
- You have been diagnosed with diabetes (Type 1 or Type 2), prediabetes, or other metabolic conditions that affect glucose or insulin responses (such as insulin resistance, metabolic syndrome, or polycystic ovary syndrome [PCOS])
- You have a history of gastrointestinal conditions that may affect digestion or absorption (such as inflammatory bowel disease, Crohn's disease, ulcerative colitis, celiac disease, or severe irritable bowel syndrome)
Show all 18Show fewer
- You have had gastrointestinal surgery that alters normal digestive function (such as bariatric surgery or gastric bypass)
- You have other medical conditions that may affect digestion or interfere with study results (such as Past or present: Organ transplant, chronic pancreatitis, pancreatic insufficiency, symptomatic biliary disease, Celiac disease, chronic constipation, diverticulosis, inflammatory bowel disease (IBD), ulcerative colitis (UC), Crohn's disease (CD), small intestine bacterial overgrowth syndrome (SIBO), gastroparesis, gastro-esophageal reflux disease (GERD), Irritable Bowel Syndrome (IBS) or any other medical condition with symptoms that could confound collection of adverse events.)
- You have used medications or supplements known to affect glucose metabolism, digestion, or gastrointestinal function within the following timeframes prior to enrollment:
- Within 4 weeks: insulin, metformin, GLP-1 receptor agonists, corticosteroids, digestive enzymes, fiber supplements, and all oral or IV antibiotics
- Within 2 weeks: bismuth-containing compounds (e.g., Pepto-Bismol) and proton pump inhibitors or acid suppressors (e.g., omeprazole [Prilosec], lansoprazole [Prevacid], esomeprazole [Nexium], pantoprazole [Protonix], rabeprazole [Aciphex])
- Within 1 week: laxatives and stool softeners (e.g., Miralax, Colace, senna, lactulose, Citrucel, Metamucil, Fibercon), probiotics and prebiotics, gastrointestinal motility agents (e.g., Reglan, Linzess, Amitiza), and antidiarrheal medications (e.g., loperamide [Imodium], Lomotil)
- You have had a recent infection within the past 30 days
- You have been diagnosed with Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C
- You are currently undergoing chemotherapy
- Height: ___ Weight: ___ BMI: ___ Weighing <16.5 kg or Body mass index > 35 kg/m2
- You have participated in another clinical trial or used an investigational product within the past 30 days
- You have any other condition that, as determined by the study team, would make participation unsafe or interfere with study results
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized Crossover Study Evaluating Postprandial Glucose and Insulin Responses to A1-Free and Conventional Milk With and Without a Delayed Lactose Challenge in Healthy Adults
This study will examine how different types of milk affect blood sugar and insulin responses after eating. Specifically, the study compares milk that contains only A2 beta-casein protein (A1-free milk) to conventional milk, which contains both A1 and A2 proteins.
Participants will complete four study visits in which they will consume different milk-based beverages. These include lactose-containing milk and lactose-free milk followed by a lactose drink given later. Blood samples will be collected over several hours to measure glucose and insulin responses. Breath tests and questionnaires will also be used to assess digestion and gastrointestinal symptoms.
The goal of this study is to determine whether milk protein type influences metabolic responses and whether consuming lactose-free milk affects how the body processes lactose when it is consumed later.
Read the detailed description
Postprandial glucose and insulin responses are important indicators of metabolic health, even in individuals without diagnosed metabolic disease. The rate and pattern of nutrient digestion and absorption can influence these responses, and emerging evidence suggests that differences in milk protein composition, specifically the presence or absence of A1 beta-casein, may alter gastrointestinal function and metabolic outcomes.
This study is a randomized, double-blind, crossover trial designed to evaluate the effects of A1-free milk compared to conventional milk on postprandial metabolic responses in healthy adults. Participants will complete four experimental conditions in random order: (1) lactose-containing A1-free milk, (2) lactose-containing conventional milk, (3) lactose-free A1-free milk followed by a delayed lactose challenge, and (4) lactose-free conventional milk followed by a delayed lactose challenge.
The inclusion of both lactose-containing and lactose-free conditions allows for evaluation of two complementary questions. First, direct comparisons between lactose-containing A1-free and conventional milk will assess whether milk protein composition influences postprandial glucose and insulin responses under typical consumption conditions. Second, the lactose-free preload conditions, combined with a standardized delayed lactose challenge, are designed to evaluate whether prior milk consumption modifies subsequent metabolic responses to lactose exposure. This approach provides insight into potential differences in digestive kinetics, including gastric emptying, nutrient delivery, and lactose digestion and absorption.
During each study visit, participants will consume a standardized milk-based intervention following an overnight fast. In the lactose-free conditions, a lactose beverage matched to the amount of lactose typically present in the milk will be administered 60 minutes after milk consumption. Blood samples will be collected at multiple timepoints over a postprandial period to measure glucose and insulin concentrations and characterize response patterns, including early-phase responses and overall exposure.
Secondary and exploratory outcomes include breath hydrogen testing as a non-invasive marker of carbohydrate fermentation and lactose maldigestion, as well as gastrointestinal symptom assessments using validated questionnaires. These measures will be used to provide additional context for interpreting metabolic responses across conditions.
The crossover design allows each participant to serve as their own control, improving statistical power and reducing variability. The findings from this study will help clarify whether differences in milk protein composition influence metabolic responses and whether prior exposure to lactose-free milk alters the body's handling of lactose consumed at a later time.
- Conditions
- Postprandial Glucose Response, Insulin Response, Lactose Digestion, Postprandial Metabolism
- Being tested
- Lactose-Containing A1-Free Milk, Lactose-Containing Conventional Milk, Lactose-Free A1-Free Milk With Delayed Lactose Drink, Lactose-Free Conventional Milk With Delayed Lactose Drink
- Keywords
- A1 beta-casein, A1-free milk, Postprandial glucose, Insulin response, Postprandial Glycemia, Digestive Kinetics, Lactose digestion, Metabolic response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactose-Containing A1-Free MilkDietary supplement
Also called A1-free milk, A2 milk
A lactose-containing milk beverage containing A2 beta-casein and no A1 beta-casein, consumed during one experimental study visit.
Lactose-Containing Conventional MilkDietary supplement
Also called Conventional milk, A1/A2 milk
A lactose-containing conventional milk beverage containing both A1 and A2 beta-casein, consumed during one experimental study visit.
Lactose-Free A1-Free Milk With Delayed Lactose DrinkDietary supplement
A lactose-free A1-free milk beverage consumed at the start of the study visit, followed by a lactose drink administered 60 minutes after milk consumption. The lactose drink is matched to the amount of lactose expected in the milk serving.
Lactose-Free Conventional Milk With Delayed Lactose DrinkDietary supplement
A lactose-free conventional milk beverage containing both A1 and A2 beta-casein consumed at the start of the study visit, followed by a lactose drink administered 60 minutes after milk consumption. The lactose drink is matched to the amount of lactose expected in the milk serving.
| Study group | Role | What they receive |
|---|---|---|
| Lactose-Containing A1-Free Milk | Experimental | Participants consume lactose-containing A1-free milk during one study visit. Blood, breath hydrogen, urine, and gastrointestinal symptom measures are collected over the 180 minute postprandial period. Receives: Dietary Supplement: Lactose-Containing A1-Free Milk |
| Lactose-Containing Conventional Milk | Experimental | Participants consume lactose-containing conventional milk containing both A1 and A2 beta-casein during one study visit. Blood, breath hydrogen, urine, and gastrointestinal symptom measures are collected over the 180 minute postprandial period. Receives: Dietary Supplement: Lactose-Containing Conventional Milk |
| Lactose-Free A1-Free Milk With Delayed Lactose Drink | Experimental | Participants consume lactose-free A1-free milk followed by a lactose drink administered 60 minutes after milk consumption. Blood, breath hydrogen, and gastrointestinal symptom measures are collected over the 180 minute postprandial period. Receives: Dietary Supplement: Lactose-Free A1-Free Milk With Delayed Lactose Drink |
| Lactose-Free Conventional Milk With Delayed Lactose Drink | Experimental | Participants consume lactose-free conventional milk containing both A1 and A2 beta-casein followed by a lactose drink administered 60 minutes after milk consumption. Blood, breath hydrogen, and gastrointestinal symptom measures are collected over the 180 minute postprandial period. Receives: Dietary Supplement: Lactose-Free Conventional Milk With Delayed Lactose Drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial Plasma Insulin Incremental Area Under the Curve (iAUC)
Incremental area under the curve (iAUC) for plasma insulin concentrations following consumption of each study condition, measured from serial blood samples collected via an indwelling catheter.
Measured: 0 to 180 minutes post-intervention during each study visit
Postprandial Plasma Glucose Incremental Area Under the Curve (iAUC)
Incremental area under the curve (iAUC) for plasma glucose concentrations following consumption of each study condition, measured from serial blood samples collected via an indwelling catheter.
Measured: 0 to 180 minutes post-intervention during each study visit
Secondary outcomes (6)
Early-Phase Postprandial Glucose and Insulin Response
Early-phase postprandial response assessed by incremental area under the curve (iAUC) for plasma glucose and insulin concentrations.
Measured: 0 to 60 minutes post-intervention
Time to Peak Plasma Glucose and Insulin Concentrations (Tmax)
Time required to reach peak plasma glucose and insulin concentrations following each study condition.
Measured: 0 to 180 minutes post-intervention
Circulating Metabolite Responses
Postprandial changes in circulating metabolites, including amino acids and acylcarnitines, measured from plasma samples to assess metabolic responses.
Measured: 0, 30, 60, and 120 minutes
Breath Hydrogen Concentrations
Breath hydrogen levels measured as a non-invasive marker of carbohydrate fermentation and lactose maldigestion.
Measured: Baseline and every 30 minutes from 0 to 180 minutes post-intervention
Gastrointestinal Symptom Scores
Self-reported gastrointestinal symptoms (e.g., bloating, gas, abdominal discomfort) assessed using visual analog scale and Likert-type questionnaires.
Measured: Baseline and at 60, 120, and 180 minutes post-intervention
Urinary Galactose Concentrations
Urinary galactose concentrations measured as an marker of lactose metabolism.
Measured: Baseline and 180 minutes post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start15 Jun 2026 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Postprandial Glucose ResponseStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dennis A. Savaiano, Purdue University
- Investigators
- Dennis A Savaiano, PhD, Principal investigator, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07567443
- Sponsor's protocol ID
- IRB 2026-00000555
- Status last verified
- Apr 2026
- First submitted
- 28 Apr 2026
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shrestha A, Samuelsson LM, Sharma P, Day L, Cameron-Smith D, Milan AM. Comparing Response of Sheep and Cow Milk on Acute Digestive Comfort and Lactose Malabsorption: A Randomized Controlled Trial in Female Dairy Avoiders. Front Nutr. 2021 Feb 15;8:603816. doi: 10.3389/fnut.2021.603816. eCollection 2021.
PubMed 33659266Ramakrishnan M, Zhou X, Dydak U, Savaiano DA. Gastric Emptying of New-World Milk Containing A1 and A2 Beta-Casein Is More Rapid as Compared to Milk Containing Only A2 Beta-Casein in Lactose Maldigesters: A Randomized, Cross-Over Trial Using Magnetic Resonance Imaging. Nutrients. 2023 Feb 4;15(4):801. doi: 10.3390/nu15040801.
PubMed 36839159Nilsson M, Stenberg M, Frid AH, Holst JJ, Bjorck IM. Glycemia and insulinemia in healthy subjects after lactose-equivalent meals of milk and other food proteins: the role of plasma amino acids and incretins. Am J Clin Nutr. 2004 Nov;80(5):1246-53. doi: 10.1093/ajcn/80.5.1246.
PubMed 15531672Gunnerud U, Holst JJ, Ostman E, Bjorck I. The glycemic, insulinemic and plasma amino acid responses to equi-carbohydrate milk meals, a pilot- study of bovine and human milk. Nutr J. 2012 Oct 12;11:83. doi: 10.1186/1475-2891-11-83.
PubMed 23057765Sun L, Tan KWJ, Han CMS, Leow MK, Henry CJ. Impact of preloading either dairy or soy milk on postprandial glycemia, insulinemia and gastric emptying in healthy adults. Eur J Nutr. 2017 Feb;56(1):77-87. doi: 10.1007/s00394-015-1059-y. Epub 2015 Oct 6.
PubMed 26439722Phillips LK, Deane AM, Jones KL, Rayner CK, Horowitz M. Gastric emptying and glycaemia in health and diabetes mellitus. Nat Rev Endocrinol. 2015 Feb;11(2):112-28. doi: 10.1038/nrendo.2014.202. Epub 2014 Nov 25.
PubMed 25421372
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Crossover Study Evaluating Postprandial Glucose and Insulin Responses to A1-Free and Conventional Milk With and Without a Delayed Lactose Challenge in Healthy Adults
- ClinicalTrials.gov ID
- NCT07567443
- Acronym / sponsor ID
- IRB 2026-00000555
- Conditions
- Postprandial Glucose Response, Insulin Response, Lactose Digestion, Postprandial Metabolism
- Keywords
- A1 beta-casein, A1-free milk, Postprandial glucose, Insulin response, Postprandial Glycemia, Digestive Kinetics, Lactose digestion, Metabolic response
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 5 May 2026 (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.
This study will examine how different types of milk affect blood sugar and insulin responses after eating. Specifically, the study compares milk that contains only A2 beta-casein protein (A1-free milk) to conventional milk, which contains both A1 and A2 proteins.
Participants will complete four study visits in which they will consume different milk-based beverages. These include lactose-containing milk and lactose-free milk followed by a lactose drink given later. Blood samples will be collected over several hours to measure glucose and insulin responses. Breath tests and questionnaires will also be used to assess digestion and gastrointestinal symptoms.
The goal of this study is to determine whether milk protein type influences metabolic responses and whether consuming lactose-free milk affects how the body processes lactose when it is consumed later.
Detailed description
Postprandial glucose and insulin responses are important indicators of metabolic health, even in individuals without diagnosed metabolic disease. The rate and pattern of nutrient digestion and absorption can influence these responses, and emerging evidence suggests that differences in milk protein composition, specifically the presence or absence of A1 beta-casein, may alter gastrointestinal function and metabolic outcomes.
This study is a randomized, double-blind, crossover trial designed to evaluate the effects of A1-free milk compared to conventional milk on postprandial metabolic responses in healthy adults. Participants will complete four experimental conditions in random order: (1) lactose-containing A1-free milk, (2) lactose-containing conventional milk, (3) lactose-free A1-free milk followed by a delayed lactose challenge, and (4) lactose-free conventional milk followed by a delayed lactose challenge.
The inclusion of both lactose-containing and lactose-free conditions allows for evaluation of two complementary questions. First, direct comparisons between lactose-containing A1-free and conventional milk will assess whether milk protein composition influences postprandial glucose and insulin responses under typical consumption conditions. Second, the lactose-free preload conditions, combined with a standardized delayed lactose challenge, are designed to evaluate whether prior milk consumption modifies subsequent metabolic responses to lactose exposure. This approach provides insight into potential differences in digestive kinetics, including gastric emptying, nutrient delivery, and lactose digestion and absorption.
During each study visit, participants will consume a standardized milk-based intervention following an overnight fast. In the lactose-free conditions, a lactose beverage matched to the amount of lactose typically present in the milk will be administered 60 minutes after milk consumption. Blood samples will be collected at multiple timepoints over a postprandial period to measure glucose and insulin concentrations and characterize response patterns, including early-phase responses and overall exposure.
Secondary and exploratory outcomes include breath hydrogen testing as a non-invasive marker of carbohydrate fermentation and lactose maldigestion, as well as gastrointestinal symptom assessments using validated questionnaires. These measures will be used to provide additional context for interpreting metabolic responses across conditions.
The crossover design allows each participant to serve as their own control, improving statistical power and reducing variability. The findings from this study will help clarify whether differences in milk protein composition influence metabolic responses and whether prior exposure to lactose-free milk alters the body's handling of lactose consumed at a later time.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Lactose-Containing A1-Free Milk | Experimental | Dietary Supplement: Lactose-Containing A1-Free MilkParticipants consume lactose-containing A1-free milk during one study visit. Blood, breath hydrogen, urine, and gastrointestinal symptom measures are collected over the 180 minute postprandial period. |
| Lactose-Containing Conventional Milk | Experimental | Dietary Supplement: Lactose-Containing Conventional MilkParticipants consume lactose-containing conventional milk containing both A1 and A2 beta-casein during one study visit. Blood, breath hydrogen, urine, and gastrointestinal symptom measures are collected over the 180 minute postprandial period. |
| Lactose-Free A1-Free Milk With Delayed Lactose Drink | Experimental | Dietary Supplement: Lactose-Free A1-Free Milk With Delayed Lactose DrinkParticipants consume lactose-free A1-free milk followed by a lactose drink administered 60 minutes after milk consumption. Blood, breath hydrogen, and gastrointestinal symptom measures are collected over the 180 minute postprandial period. |
| Lactose-Free Conventional Milk With Delayed Lactose Drink | Experimental | Dietary Supplement: Lactose-Free Conventional Milk With Delayed Lactose DrinkParticipants consume lactose-free conventional milk containing both A1 and A2 beta-casein followed by a lactose drink administered 60 minutes after milk consumption. Blood, breath hydrogen, and gastrointestinal symptom measures are collected over the 180 minute postprandial period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Ability/desire to provide informed consent
- Are between 18 and 65 years of age
- Are generally healthy, with no known metabolic or gastrointestinal conditions that would affect digestion or metabolism
- Are willing to consume milk-based beverages and lactose-containing drinks as part of the study
- Are willing to fast overnight (approximately 10-12 hours) prior to study visits and follow study instructions (e.g., diet and activity restrictions)
Key exclusion criteria (18 listed)
- You have a known allergy to milk or dairy products
- You are currently pregnant, planning to become pregnant, or breastfeeding
- You currently smoke or have used tobacco or nicotine-containing products within the past 3 months
- You have a history of excessive alcohol use within the past 30 days
- You have been diagnosed with diabetes (Type 1 or Type 2), prediabetes, or other metabolic conditions that affect glucose or insulin responses (such as insulin resistance, metabolic syndrome, or polycystic ovary syndrome [PCOS])
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 A1-Free MilkAlso: A1-free milk, A2 milkA lactose-containing milk beverage containing A2 beta-casein and no A1 beta-casein, consumed during one experimental study visit. | Dietary supplement | Lactose-Containing A1-Free Milk |
| Lactose-Containing Conventional MilkAlso: Conventional milk, A1/A2 milkA lactose-containing conventional milk beverage containing both A1 and A2 beta-casein, consumed during one experimental study visit. | Dietary supplement | Lactose-Containing Conventional Milk |
| Lactose-Free A1-Free Milk With Delayed Lactose DrinkA lactose-free A1-free milk beverage consumed at the start of the study visit, followed by a lactose drink administered 60 minutes after milk consumption. The lactose drink is matched to the amount of lactose expected in the milk serving. | Dietary supplement | Lactose-Free A1-Free Milk With Delayed Lactose Drink |
| Lactose-Free Conventional Milk With Delayed Lactose DrinkA lactose-free conventional milk beverage containing both A1 and A2 beta-casein consumed at the start of the study visit, followed by a lactose drink administered 60 minutes after milk consumption. The lactose drink is matched to the amount of lactose expected in the milk serving. | Dietary supplement | Lactose-Free Conventional Milk With Delayed Lactose Drink |
Primary outcome
Postprandial Plasma Insulin Incremental Area Under the Curve (iAUC)
Time frame: 0 to 180 minutes post-intervention during each study visit
Incremental area under the curve (iAUC) for plasma insulin concentrations following consumption of each study condition, measured from serial blood samples collected via an indwelling catheter.
Postprandial Plasma Glucose Incremental Area Under the Curve (iAUC)
Time frame: 0 to 180 minutes post-intervention during each study visit
Incremental area under the curve (iAUC) for plasma glucose concentrations following consumption of each study condition, measured from serial blood samples collected via an indwelling catheter.
6 secondary outcomes
Early-Phase Postprandial Glucose and Insulin Response
Time frame: 0 to 60 minutes post-intervention
Time to Peak Plasma Glucose and Insulin Concentrations (Tmax)
Time frame: 0 to 180 minutes post-intervention
Circulating Metabolite Responses
Time frame: 0, 30, 60, and 120 minutes
Breath Hydrogen Concentrations
Time frame: Baseline and every 30 minutes from 0 to 180 minutes post-intervention
Gastrointestinal Symptom Scores
Time frame: Baseline and at 60, 120, and 180 minutes post-intervention
Urinary Galactose Concentrations
Time frame: Baseline and 180 minutes post intervention
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 5 May 2026.
- Background: PubMed 33659266Shrestha A, Samuelsson LM, Sharma P, Day L, Cameron-Smith D, Milan AM. Comparing Response of Sheep and Cow Milk on Acute Digestive Comfort and Lactose Malabsorption: A Randomized Controlled Trial in Female Dairy Avoiders. Front Nutr. 2021 Feb 15;8:603816. doi: 10.3389/fnut.2021.603816. eCollection 2021.
- Background: PubMed 36839159Ramakrishnan M, Zhou X, Dydak U, Savaiano DA. Gastric Emptying of New-World Milk Containing A1 and A2 Beta-Casein Is More Rapid as Compared to Milk Containing Only A2 Beta-Casein in Lactose Maldigesters: A Randomized, Cross-Over Trial Using Magnetic Resonance Imaging. Nutrients. 2023 Feb 4;15(4):801. doi: 10.3390/nu15040801.
- Background: PubMed 15531672Nilsson M, Stenberg M, Frid AH, Holst JJ, Bjorck IM. Glycemia and insulinemia in healthy subjects after lactose-equivalent meals of milk and other food proteins: the role of plasma amino acids and incretins. Am J Clin Nutr. 2004 Nov;80(5):1246-53. doi: 10.1093/ajcn/80.5.1246.
- Background: PubMed 23057765Gunnerud U, Holst JJ, Ostman E, Bjorck I. The glycemic, insulinemic and plasma amino acid responses to equi-carbohydrate milk meals, a pilot- study of bovine and human milk. Nutr J. 2012 Oct 12;11:83. doi: 10.1186/1475-2891-11-83.
- Background: PubMed 26439722Sun L, Tan KWJ, Han CMS, Leow MK, Henry CJ. Impact of preloading either dairy or soy milk on postprandial glycemia, insulinemia and gastric emptying in healthy adults. Eur J Nutr. 2017 Feb;56(1):77-87. doi: 10.1007/s00394-015-1059-y. Epub 2015 Oct 6.
- Background: PubMed 25421372Phillips LK, Deane AM, Jones KL, Rayner CK, Horowitz M. Gastric emptying and glycaemia in health and diabetes mellitus. Nat Rev Endocrinol. 2015 Feb;11(2):112-28. doi: 10.1038/nrendo.2014.202. Epub 2014 Nov 25.
- 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.
Dennis A Savaiano, PhD principal investigator
Purdue University
Questions about this trial
What is this clinical trial studying?
A study testing Lactose-Containing A1-Free Milk, Lactose-Containing Conventional Milk and Lactose-Free A1-Free Milk With Delayed Lactose Drink in people with Postprandial Glucose Response and Insulin Response, run by Purdue University.
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 7 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: opening soon, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Laura A Robinson, PhD (908-442-3688, ldelvers@purud.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial Plasma Insulin Incremental Area Under the Curve (iAUC) (time frame: 0 to 180 minutes post-intervention during each study visit). The study lists 2 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 NCT07567443, which also lists 6 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 5 May 2026; AzTrials last refreshed its copy on 30 Oct 2026.