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

Primary Purpose

Gut Inflammation

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Oral consumption of milk A1 in study phase 1

Oral consumption of milk A2 in study phase 1

Oral consumption of milk A1 in study phase 2

Oral consumption of milk A2 in study phase 2

About this trial

This is an interventional basic science trial for Gut Inflammation

Eligibility Criteria

5 Years - 6 Years (Child)All SexesAccepts 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Sequence A1-A2

Sequence A2-A1

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).

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).

Serum C-reactive protein (CRP) concentration

Only measured in phase 1

Serum Hemoglobin (HGB) concentration

Only measured in phase 1

Serum Interleukin-4 (IL-4) concentration

Only measured in phase 1

Serum Immunoglobulin G (IgG) concentration

Only measured in phase 1

Serum Immunoglobulin E (IgE) concentration

Only measured in phase 1

Serum Immunoglobulin G1 (IgG1) concentration

Only measured in phase 1

Serum Immunoglobulin G2a (IgG2a) concentration

Only measured in phase 1

Serum β-Casomorphin-7 (BCM-7) concentration

Only measured in phase 1

Serum Glutathione concentration

Only measured in phase 1

Serum calcium (Ca) concentration

Only measured in phase 1

Serum iron (Fe) concentration

Only measured in phase 1

Serum zinc (Zn) concentration

Only measured in phase 1

Fecal short chain fatty acids (SCFA) concentration

Measured at baseline and post-intervention in each study phase

myeloperoxidase (MPO)

Measured at baseline and post-intervention in each study phase

Subtle Cognitive Impairment Test (SCIT)

Subject response time and error rate at stimulus exposure duration of 16, 32, 48, 64, 80, 96, 112 and 128 millisecond, as well as their head and tail means were recorded at baseline (day 1 for phase 1 and day 15 for phase 2) and the end of intervention (day 5 for phase 1 and day 19 for phase 2).

Full Information

NCT ID

NCT03081845

First Posted

February 28, 2017

Last Updated

March 10, 2017

Sponsor

a2 Milk Company Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03081845

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

September 13, 2016 (Actual)

Primary Completion Date

October 14, 2016 (Actual)

Study Completion Date

January 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

a2 Milk Company Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gut Inflammation

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sequence A1-A2

Arm Type

Experimental

Arm Description

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

Arm Title

Sequence A2-A1

Arm Type

Experimental

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Oral consumption of milk A1 in study phase 1

Intervention Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

Oral consumption of milk A2 in study phase 1

Intervention Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

Oral consumption of milk A1 in study phase 2

Intervention Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

Oral consumption of milk A2 in study phase 2

Intervention Description

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 2.

Primary Outcome Measure Information:

Title

Change from baseline of gastrointestinal symptom VAS scores

Description

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 Outcome Measure Information:

Title

Stool frequency

Description

Time Frame

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

Title

Stool consistency

Description

Time Frame

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

Title

Serum C-reactive protein (CRP) concentration

Description

Only measured in phase 1

Time Frame