Effects Comparison of A1 and A2 Milk on Gastrointestinal Physiology, Symptoms and Cognitive Behavior

Launched by A2 MILK COMPANY LTD. · Apr 1, 2015

Keywords

ClinConnect Summary

This is a single-site, double-blinded, randomized, controlled, cross-over study in healthy milk drinkers of 4 weeks' consumption with milk containing only A2 type beta casein (called A2 milk) versus milk containing both A1 and A2 beta casein proteins (called A1 milk) to compare the effects on gut inflammation (CRP, HB, IL-4, IgG, IgE, IgG1, IgG2a), gastrointestinal symptoms (via VAS score including Bloating, Abdominal pain, Flatulence, Break wind, Borborygmi), regional gut transit times (via 'Smart Pill') and behavioral well-being (CNAQ), and stool habits.

The cross-over study will take 2 ...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * 25\~3568 years old male or female subjects who:
• • Non-regular milk drinker with self-reported intolerance to commercial milk;
• • Suffered from mild to moderate digestive discomfort after milk consumption;
• • Have normal electrocardiograms (ECG) and blood pressure during quiet respiration;
• • Agree not to take any medication, supplements, nutrition or other dairy products including acidophilus milk;
• • Be willing to comply with all the requirements and procedures of the study;
• • Agree to sign the informed consent form;
• • Agree not to enroll in another interventional clinical research study while participating in this study;
• • Fully understand the nature, objective, benefit and the potential risks and side effects of the study.
• Exclusion Criteria:
• • Female on pregnant or feeding；
• • Have known dairy allergy;
• • Have severe response to milk intolerance;
• • Have history of faecal impaction;
• • Trying to lose weight by following a diet or exercise regimen designed for weight loss, or taking any drug influencing appetite and any drug for weight loss for the last three months ;
• • Have participated in similar dairy or probiotics-containing product's clinical trials within 3 months before the screening;
• • Currently taking medicines for cardiovascular or metabolic disease;
• • Have history of or be diagnosed of any of the following diseases that may affect the study results: gastrointestinal disorders, hepatopathy, nephropathy, endocrine disease, blood disorders, respiratory and cardiovascular diseases;
• • Current or previous alcohol abuser, currently taking or took illicit drugs, substance or OTC prescription drugs in regular frequency which may affect gastrointestinal disorders and study result;
• • Currently suffering from any gastrointestinal disorders or gastrointestinal disease, including but not limited to: irritable bowel syndrome, colitis, ulcerative colitis, celiac disease, irritable bowel syndrome(IBS);
• • Had hospitalizations within 3 months before screening;
• • Currently drug frequency user of that may affect the gastrointestinal function or immune system. As judged by investigator.