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

a2 Milk

Status and phase: Completed; Phase 4

Conditions: Gut Inflammation

Treatments: Dietary Supplement: Oral consumption of milk A1 in study phase 2; Dietary Supplement: Oral consumption of milk A2 in study phase 1; Dietary Supplement: Oral consumption of milk A1 in study phase 1; Dietary Supplement: Oral consumption of milk A2 in study phase 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT03081845

15-SC-5-A2-002

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 80 patients

Sex: All

Ages: 5 to 6 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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80 participants in 2 patient groups

Sequence A1-A2

Experimental group

Description:

Oral consumption of milk A1 in study phase 1. Oral consumption of milk A2 in study phase 2.

Treatment:

Dietary Supplement: Oral consumption of milk A2 in study phase 2

Dietary Supplement: Oral consumption of milk A1 in study phase 1

Sequence A2-A1

Experimental group

Description:

Oral consumption of milk A2 in study phase 1. Oral consumption of milk A1 in study phase 2.

Treatment:

Dietary Supplement: Oral consumption of milk A1 in study phase 2

Dietary Supplement: Oral consumption of milk A2 in study phase 1