Recruiting

A2 Milk

Sponsor:

Purdue University

Code:

NCT05669274

Conditions

Lactose Intolerance

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Milk containing A1 and A2 beta-casein

Milk containing only A2 beta-casein

Study Details

Brief summary:

Cow's milk contains two types of β-casein: A1 and A2. It is evident from human clinical trials that milk with A1 protein produces more hydrogen and symptoms of lactose intolerance. A pro-inflammatory μ-opioid peptide BCM-7 is released from A1 but not from A2. Milk containing A1 β-casein produced more inflammatory markers than A2 β-casein. This is a double-blinded, randomized, controlled trial conducted to determine if there are changes in inflammatory markers following two weeks of milk feeding, due to milk containing A1 and A2 beta-casein as compared to milk containing only A2 beta-casein.

Conditions

Lactose Intolerance

Study ID

NCT05669274

Start date

Dec 2, 2021

Status verified date

Mar, 2023

Completion date

Dec 6, 2025

Anticipated

Primary completion date

Dec 6, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Ability/desire to provide informed consent Aged 18 to 65 years of age inclusive at screening Current or recent history of intolerance to or avoidance of dairy of at least one month duration (by self-report and self-reported symptoms).

Agrees to refrain from all other treatments and products used for dairy intolerance (e.g., Lactaid® Dietary Supplements) during study involvement Willing to return for all study visits and complete all study related procedures Able to understand and provide written informed consent in English

Exclusion Criteria:

  • Allergic to milk

Currently pregnant Currently lactating Cigarette smoking or other use of tobacco or nicotine containing products within 3 months of screening Diagnosed with any of the following disorders known to be associated with abnormal gastrointestinal motility such as; Gastroparesis, amyloidosis, neuromuscular diseases (including Parkinson's disease), collagen vascular diseases, alcoholism, uremia, malnutrition, or untreated hypothyroidism History of surgery that alters the normal function of the gastrointestinal tract including, but not limited to: gastrointestinal bypass surgery, bariatric surgery, gastric banding, vagotomy, fundoplication, pyloroplasty \[Note: history of uncomplicated abdominal surgeries such as removal of an appendix more than 12 months prior to screening will not be excluded\] 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.

Active ulcers, or history of severe ulcers Diabetes mellitus (type 1 and type 2) Congestive Heart Failure (CHF) Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C Height: ___ Weight: ___ BMI: ___

o Weighing <16.5 kg and BMI > 35 kg/m2

Recent bowel preparation for endoscopic or radiologic investigation within four weeks of screening (e.g., colonoscopy prep) Use of concurrent therapy(ies) or other products (e.g., laxatives, stool softeners, Pepto Bismol®, Lactaid® Dietary Supplements) used for symptoms of dairy intolerance within 7 days of screening Chronic antacid and/or PPI use Recent use of systemic antibiotics defined as use within 30 days prior to screening Recent high colonic enema, defined as use within 30 days prior to screening Any concurrent disease or symptoms which may interfere with the assessment of the cardinal symptoms of dairy intolerance (i.e., gas, diarrhea, bloating, cramps, stomach pain) History of ethanol (alcohol) and/or drug abuse in the past 12 months Currently undergoing chemotherapy Use of any investigational drug or participation in any investigational study within 30 days prior to screening Prior enrollment in this study Any other conditions/issues noted by the study staff and/or Principal Investigator that would impact participation and/or protocol compliance

Study Design

Enrollment

35 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Old World milk

Old World milk containing only a2 beta-casein vs. New World milk that includes both a1 and a2 beta-casein

experimental: New World milk

Old World milk containing only a2 beta-casein vs. New World milk that includes both a1 and a2 beta-casein

Interventions

Milk containing A1 and A2 beta-casein

Milk dose for 2 weeks

Milk containing only A2 beta-casein

Milk dose for 2 weeks

Primary outcome measure

  • Difference in inflammation between commercial and A2 milk [ Time Frame: Baseline blood draw on day 1 and within the 3 hours following milk dose on day 15 ]
  • Difference in hydrogen between commercial and A2 milk [ Time Frame: Within the 6 hours following milk dose on day 15 ]
  • Difference in symptoms between commercial and A2 milk [ Time Frame: From day 1 to day 14 after 500 ml milk consumption and within the 6 hours following milk dose on day 15 ]

Central Contacts and Locations

Central contacts

Tracy Eaton, MSW

tkeaton@purdue.edu

Locations

Purdue University

Recruiting

West Lafayette, Indiana, United States, 47907

Contacts

Tracy Eaton, MSW

tkeaton@purdue.edu

More Information

Sponsor

Purdue University

Last update posted

Mar 30, 2023

Last verified

Mar, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Purdue University on 2023-03-30.