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

NCT03081845 | Completed Phase 4

• 1 other identifier: 15-SC-5-A2-002
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gut Inflammation

Outcome Measures

Primary Outcomes (1)

• 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).

  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 (17)

• Stool frequency

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

• Stool consistency

  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

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

• Serum Hemoglobin (HGB) concentration

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

• Serum Interleukin-4 (IL-4) concentration

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

Study Arms (2)

Sequence A1-A2

EXPERIMENTAL

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

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

Sequence A2-A1

EXPERIMENTAL

Oral consumption of milk A2 in study phase 1. 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 2

Interventions

Oral consumption of milk A1 in study phase 1 DIETARY_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.

Sequence A1-A2

Oral consumption of milk A2 in study phase 1 DIETARY_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.

Sequence A2-A1

Oral consumption of milk A1 in study phase 2 DIETARY_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.

Sequence A2-A1

Oral consumption of milk A2 in study phase 2 DIETARY_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 2.

Sequence A1-A2

Eligibility Criteria

• Age: 5 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• a2 Milk Company Ltd.: lead

Related Publications (1)

• Sheng X, Li Z, Ni J, Yelland G. Effects of Conventional Milk Versus Milk Containing Only A2 beta-Casein on Digestion in Chinese Children: A Randomized Study. J Pediatr Gastroenterol Nutr. 2019 Sep;69(3):375-382. doi: 10.1097/MPG.0000000000002437.

  PMID: 31305326 DERIVED

Study Officials

• Li Zhang, MD

  Sprim (Shanghai) Consulting Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2017
• First Posted: March 16, 2017
• Study Start: September 13, 2016
• Primary Completion: October 14, 2016
• Study Completion: January 20, 2017
• Last Updated: March 16, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share