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

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.

Inclusion Criteria:• Ability/desire to provide informed consentAged 18 to 65 years of age inclusive at screeningCurrent 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 involvementWilling to return for all study visits and complete all study related proceduresAble to understand and provide written informed consent in EnglishExclusion Criteria:• Allergic to milkCurrently pregnantCurrently lactatingCigarette smoking or other use of tobacco or nicotine containing products within 3 months of screeningDiagnosed 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 hypothyroidismHistory 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 ulcersDiabetes mellitus (type 1 and type 2)Congestive Heart Failure (CHF)Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis CHeight: ___ Weight: ___ BMI: ___o Weighing <16.5 kg and BMI > 35 kg/m2Recent 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 screeningChronic antacid and/or PPI useRecent use of systemic antibiotics defined as use within 30 days prior to screeningRecent high colonic enema, defined as use within 30 days prior to screeningAny concurrent disease or symptoms which may interfere with the assessment of the cardinalsymptoms of dairy intolerance (i.e., gas, diarrhea, bloating, cramps, stomach pain)History of ethanol (alcohol) and/or drug abuse in the past 12 monthsCurrently undergoing chemotherapyUse of any investigational drug or participation in any investigational study within 30 days prior to screeningPrior enrollment in this studyAny other conditions/issues noted by the study staff and/or Principal Investigator that would impact participation and/or protocol compliance