Effects Comparison of A1 and A2 Milk on Gastrointestinal Physiology, Symptoms and Cognitive Behavior (NCT02406469) | Clinical Trial Compass
CompletedPhase 4
Effects Comparison of A1 and A2 Milk on Gastrointestinal Physiology, Symptoms and Cognitive Behavior
45 participantsStarted 2014-10
Plain-language summary
This is a single-site, double-blinded, randomized, controlled, 2X2 cross-over study aiming to compare effects of milk containing only A2 type beta casein versus milk containing both A1 and A2 beta casein proteins on the gastrointestinal physiology, symptoms and cognitive behaviour for the health people who are intolerant to traditional cow's milk.
Who can participate
Age range25 Years – 68 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 feedingï¼›
* 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, respira…
What they're measuring
1
Serum levels of immune response markers in correlation to symptoms of intolerance
Timeframe: Baseline 1 (Day 0), end of intervention phase 1 (Day 14), baseline 2 (Day 28), end of intervention phase 2 (Day 42)