A1 Versus A2® Milk on the Gastrointestinal Physiology, Symptoms and Cognitive Behaviour for the Preschool Children

a2 Milk Company Ltd.80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Gut Inflammation

Interventions

Oral consumption of milk A1 in study phase 1DIETARY_SUPPLEMENT

Oral consumption of 250 ml of milk containing both A1 and A2 type beta casein 2 times per day after meal for 5 days in study phase 1.

Oral consumption of milk A2 in study phase 1DIETARY_SUPPLEMENT

Oral consumption of 250 ml of milk containing only A2 type beta casein 2 times per day after meal for 5 days in study phase 1.

Oral consumption of milk A1 in study phase 2DIETARY_SUPPLEMENT

Oral consumption of 250 ml of milk containing both A1 and A2 type beta casein 2 times per day after meal for 5 days in study phase 2.

Eligibility

Sex: ALLMin age: 5 YearsMax age: 6 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Non-regular milk drinker; * Suffered from mild to moderate milk intolerance; * Agree not to take any medication, supplements, nutrition or other dairy products including acidophilus milk; * Parent(s) or legal guardian's consent to the study and willing to comply with study procedures; * Parent(s) or guardian of infant agrees not to enroll infant another clinical study while participating in this study; * Fully understand the nature, objective, benefit and the potential risks and side effects of the study. Exclusion Criteria: * Have known dairy allergy; * Suffered from severe milk intolerance; * Unable to give written informed consent; * Use of antibiotics at the time of screening, or during the past two weeks; * Have history of fecal 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; * 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; * According to investigator's judgment, current frequent users of drugs may affect the gastrointestinal function or immune system.

Outcomes

Primary Outcomes

Change from baseline of gastrointestinal symptom VAS scores

were self-measured by study subjects on a scale from 0 (never) to 3 (always) at baseline (day 1 for phase 1 and day 15 for phase 2, before product consumption) and at the end of the 5-day product consumption (day 5 for phase 1 and day 19 for phase 2).

Time frame: Baseline (day 1 for phase 1 and day 15 for phase 2, before product consumption), at the end of the 5-day product consumption (day 5 for phase 1 and day 19 for phase 2)

Secondary Outcomes

Stool frequency

In each study phase, the number of defecation per day measured during the last 5 days of wash-out period (day -4, -3, -2, -1, 0 in phase 1 and day 10, 11, 12, 13, 14 in phase 2) and the 5 days of product intervention (day 1, 2, 3, 4, 5 in phase 1 and day 15, 16, 17, 18, 19 in phase 2).

Time frame: Day -4, -3, -2, -1, 0, 1, 2, 3, 4, 5, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19

Stool consistency

In each study phase, the score of stool consistency assessed using Bristol Stool Chart during the last 5 days of wash-out period (day -4, -3, -2, -1, 0 in phase 1 and day 10, 11, 12, 13, 14 in phase 2) and the 5 days of product intervention (day 1, 2, 3, 4, 5 in phase 1 and day 15, 16, 17, 18, 19 in phase 2).

Time frame: Day -4, -3, -2, -1, 0, 1, 2, 3, 4, 5, 10, 11, 12, 13, 14, 5, 16, 17, 18, 19

Serum C-reactive protein (CRP) concentration

Only measured in phase 1

Time frame: Day 1 before intervention (baseline), and day 5 (post-intervention)

Serum Hemoglobin (HGB) concentration

Only measured in phase 1

Time frame: Day 1 before intervention (baseline), and day 5 (post-intervention)

Serum Interleukin-4 (IL-4) concentration

Data from ClinicalTrials.gov

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