Milk Free From A1-Type β-Casein on Inflammation, Gastrointestinal Tolerance, and Pregnancy Outcomes

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-35
Sponsora2 Milk Company Ltd.

About this trial

The aim of the study is to compare the effects of conventional Ultra High Temperature (UHT) milk containing both A1 and A2 type β-caseins (CON) with a2 UHT Milk containing A2 type β-casein only (A1PF) on inflammation, tolerance, and GI symptoms in pregnant women as well as infants' birth outcomes from 12 weeks' gestation up to 40 days post-birth.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

20-35 years of age

Recruited at <12 weeks of gestation

Intention to deliver at study site hospital

Singleton pregnancy

Disqualifiers

Body mass index ≥ 35 at enrolment

Cow's milk intolerance or allergy

Significant systemic disorder (e.g., cardiac, respiratory, endocrinological, hemato-logic, or GI); pre-pregnancy diabetes, hypertension, or other medical conditions that preclude participation per the investigator's judgement

Taking any prescribed chronic medications

Trial design

Design model

Parallel

Treatments tested in this trial

  • a2 UHT milk

    Other intervention

    Pregnant women in this arm will drink a2 UHT Milk twice a day, 200ml each time, until study completion. Their infants will be fed with the mother's breastmilk exclusively.

  • Conventional UHT Milk

    Other intervention

    Pregnant women in this arm will drink conventional UHT Milk twice a day, 200ml each time, until study completion. Their infants will be fed with the mother's breastmilk exclusively.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: a2 UHT MilkActive comparator 1 intervention
Group B: Conventional UHT milkPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

GI tolerance

GI tolerance via the GSRS questionnaire

Time frame
Visit 1 (baseline, 12 weeks' gestation)
2

GI tolerance

GI tolerance via the GSRS questionnaire

Time frame
Visit 2 (24 weeks' gestation)
3

GI tolerance

GI tolerance via the GSRS questionnaire

Time frame
Visit 3 (36 weeks' gestation)
4

GI tolerance

GI tolerance via the GSRS questionnaire

Time frame
Visit 4 (40 days after delivery)

Secondary outcomes

1

pregnancy complications

Incidence of pregnancy complications

Time frame
Visit 1 (baseline, 12 weeks' gestation)
2

pregnancy complications

Incidence of pregnancy complications

Time frame
Visit 2 (24 weeks' gestation)
3

pregnancy complications

Incidence of pregnancy complications

Time frame
Visit 3 (36 weeks' gestation)
4

pregnancy complications

Incidence of pregnancy complications

Time frame
Visit 4 (40 days after delivery)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

a2 Milk Company Ltd.

Lead sponsor

Edanz Inc

Collaborator

Cyanth (Wuxi) Health Technology Co. Ltd.

Collaborator

Affilicated Hospital of Jiangnan University

Collaborator

Guangzhou Trials Medical

Collaborator