Gut Inflammation Clinical Trial
Official title:
Comparative Effects of A1 Versus A2® Milk on the Gastrointestinal Physiology, Symptoms and Cognitive Behaviour for the Preschool Children: a Double-blinded Randomized Controlled Cross-over Study
This is a multiple-sites, double-blinded, randomized, controlled, parallel-designed, cross-over study among healthy preschoolers with 5 days consumption of A2 or A1 milk to compare the effects on gut inflammation, gastrointestinal symptoms and behavioral well-being.
Gut inflammation is reflected by serum C-Reactive Protein (CRP), hemoglobin (HB),
interleukin-4 (IL-4), Immunoglobulin G (IgG), Immunoglobulin E (IgE), Immunoglobulin G1
(IgG1), Immunoglobulin G2a (IgG2a), β-Casomorphin-7 (BCM-7), Glutathione, calcium (Ca), iron
(Fe) and zinc (Zn) concentration; gastrointestinal (GI) symptoms are measured via Visual
Analog Scale (VAS) for gut tolerance, including borborygmus, bloating, break wind, abdominal
pain, and diarrhea; behavioral well-being is assessed using Subtle Cognitive Impairment Test
(SCIT).
The total duration of study was 24 weeks, including subject enrollment, study intervention,
laboratory testing, and providing clinical study report. The cross-over study consisted of 5
days of each product intervention; 10 days of wash-out in phase 1 and phase 2, respectively;
and then followed by 6 weeks of statistical analysis and clinical report completion.
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