Comparing the Inflammation, Maldigestion and Symptoms Due to Commercial Milk and A2 Milk

Status unconfirmed · Not applicable

Conditions studied: Lactose Intolerance

In brief

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 A1 beta-casein containing milk causes acute effects on inflammatory markers following a single milk feeding, as compared to milk containing only A2 beta-casein.

Key facts

Study ID

NCT05660278

Run by

Purdue University

People needed

35

Starts

2022-01-18

Expected to finish

2025-08-01

Last updated by the study team

2022-12-21

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• • 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

You may not qualify if…

• • 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

Where it is running

• Purdue University — West Lafayette, Indiana, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.