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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
a2 UHT milk
Other interventionPregnant 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 interventionPregnant 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
Trial outcomes
Primary outcomes
GI tolerance
GI tolerance via the GSRS questionnaire
GI tolerance
GI tolerance via the GSRS questionnaire
GI tolerance
GI tolerance via the GSRS questionnaire
GI tolerance
GI tolerance via the GSRS questionnaire
Secondary outcomes
pregnancy complications
Incidence of pregnancy complications
pregnancy complications
Incidence of pregnancy complications
pregnancy complications
Incidence of pregnancy complications
pregnancy complications
Incidence of pregnancy complications
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