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

NCT03081845 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2017-03-16

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Oral consumption of milk A1 in study phase 1

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.

DIETARY_SUPPLEMENT

Oral consumption of milk A2 in study phase 1

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.

DIETARY_SUPPLEMENT

Oral consumption of milk A1 in study phase 2

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.

DIETARY_SUPPLEMENT

Oral consumption of milk A2 in study phase 2

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.

Sponsors & Collaborators

  • a2 Milk Company Ltd.

    lead INDUSTRY

Principal Investigators

  • Li Zhang, MD · Sprim (Shanghai) Consulting Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
5 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-13
Primary Completion
2016-10-14
Completion
2017-01-20

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03081845 on ClinicalTrials.gov