Healthy Pregnant Women
Conditions
Brief summary
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.
Interventions
OTHERa2 UHT milk
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.
OTHERConventional UHT Milk
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.
Sponsors
a2 Milk Company Ltd.
Edanz Inc
Cyanth (Wuxi) Health Technology Co. Ltd.
Affiliated Hospital of Jiangnan University
Guangzhou Trials Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* 20-35 years of age * Recruited at \<12 weeks of gestation * Intention to deliver at study site hospital * Singleton pregnancy * Able and willing to consume milk during pregnancy * Agree not to participate in another interventional clinical study during the present study
Exclusion criteria
* 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 * Participation in another clinical trial * Investigator uncertainty about the willingness or ability of the participant to comply with the protocol requirements * Taking probiotics at screening or two weeks before enrolment * Receiving any vaccine at screening or two weeks before enrolment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| GI tolerance | Visit 1 (baseline, 12 weeks' gestation) | GI tolerance via the GSRS questionnaire |
| IL-4 | Visit 1 (baseline, 12 weeks' gestation) | Blood IL-4 levels |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pregnancy complications | Visit 1 (baseline, 12 weeks' gestation) | Incidence of pregnancy complications |
| GSH levels | Visit 1 (baseline, 12 weeks' gestation) | Blood GSH levels |
| IgG levels | Visit 1 (baseline, 12 weeks' gestation) | Blood IgG levels |
| IL-1 levels | Visit 1 (baseline, 12 weeks' gestation) | Blood IL-1 levels |
| hsCRP | Visit 1 (baseline, 12 weeks' gestation) | Blood hsCRP levels |
| TNF-α | Visit 1 (baseline, 12 weeks' gestation) | Blood TNF-α levels |
| Vitamin D | Visit 1 (baseline, 12 weeks' gestation) | Blood vitamin D levels |
| Infant birth outcomes | Visit 4 (40 days after delivery) | Infant birth outcomes, including anthropometric measurements (weight, length, head circumference, z-scores, Apgar score) |
| Breastmilk composition | Visit 4 (40 days after delivery) | Breastmilk composition analyssis including metal ion testing, proteins, fats and HMOs |
| infant GI signs and symptoms | Visit 4 (40 days after delivery) | infant GI signs and symptoms assessed by IGSQ questionnaire |
| Adverse events | Visit 1 (baseline, 12 weeks' gestation) | Record adverse events |
Countries
China
Outcome results
None listed