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

N/AActive Not RecruitingNCT06980376

a2 Milk Company Ltd.100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

100

Conditions

Healthy Pregnant Women

Interventions

a2 UHT milkOTHER

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 MilkOTHER

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.

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (6)

Foshan Maternity & Child Healthcare Hospital

Foshan, Guangdong, China

Panyu Maternal and Child Care Service Centre of Guangzhou

Guangzhou, Guangdong, China

Wuxi Maternal and Child Health Hospital

Wuxi, Jiangsu, China

Affiliated hospital of Jiangnan University

Wuxi, Jiangsu, China

Outcomes

Primary Outcomes

GI tolerance

GI tolerance via the GSRS questionnaire

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

GI tolerance

GI tolerance via the GSRS questionnaire

Time frame: Visit 2 (24 weeks' gestation)

GI tolerance

GI tolerance via the GSRS questionnaire

Time frame: Visit 3 (36 weeks' gestation)

GI tolerance

GI tolerance via the GSRS questionnaire

Time frame: Visit 4 (40 days after delivery)

IL-4

Blood IL-4 levels

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

IL-4

Blood IL-4 levels

Time frame: Visit 2 (24 weeks' gestation)

IL-4

Blood IL-4 levels

Time frame: Visit 3 (36 weeks' gestation)

Secondary Outcomes

pregnancy complications

Incidence of pregnancy complications

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

pregnancy complications

Incidence of pregnancy complications

Time frame: Visit 2 (24 weeks' gestation)

Data from ClinicalTrials.gov

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Xuzhou Maternal and Child Health Hospital

Xuzhou, Jiangsu, China

First People's Hospital of Chengdu

Chengdu, Sichuan, China

pregnancy complications

Incidence of pregnancy complications

Time frame: Visit 3 (36 weeks' gestation)

pregnancy complications

Incidence of pregnancy complications

Time frame: Visit 4 (40 days after delivery)

GSH levels

Blood GSH levels

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

GSH levels

Blood GSH levels

Time frame: Visit 2 (24 weeks' gestation)

GSH levels

Blood GSH levels

Time frame: Visit 3 (36 weeks' gestation)

IgG levels

Blood IgG levels

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

IgG levels

Blood IgG levels

Time frame: Visit 2 (24 weeks' gestation)

IgG levels

Blood IgG levels

Time frame: Visit 3 (36 weeks' gestation)

IL-1 levels

Blood IL-1 levels

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

IL-1 levels

Blood IL-1 levels

Time frame: Visit 2 (24 weeks' gestation)

IL-1 levels

Blood IL-1 levels

Time frame: Visit 3 (36 weeks' gestation)

hsCRP

Blood hsCRP levels

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

hsCRP

Blood hsCRP levels

Time frame: Visit 2 (24 weeks' gestation)

hsCRP

Blood hsCRP levels

Time frame: Visit 3 (36 weeks' gestation)

TNF-α

Blood TNF-α levels

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

TNF-α

Blood TNF-α levels

Time frame: Visit 2 (24 weeks' gestation)

TNF-α

Blood TNF-α levels

Time frame: Visit 3 (36 weeks' gestation)

Vitamin D

Blood vitamin D levels

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

Vitamin D

Blood vitamin D levels

Time frame: Visit 2 (24 weeks' gestation)

Vitamin D

Blood vitamin D levels

Time frame: Visit 3 (36 weeks' gestation)

Infant birth outcomes

Infant birth outcomes, including anthropometric measurements (weight, length, head circumference, z-scores, Apgar score)

Time frame: Visit 4 (40 days after delivery)

Breastmilk composition

Breastmilk composition analyssis including metal ion testing, proteins, fats and HMOs

Time frame: Visit 4 (40 days after delivery)

infant GI signs and symptoms

infant GI signs and symptoms assessed by IGSQ questionnaire

Time frame: Visit 4 (40 days after delivery)

Adverse events

Record adverse events

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

Adverse events

Record adverse events

Time frame: Visit 2 (24 weeks' gestation)

Adverse events

Record adverse events

Time frame: Visit 3 (36 weeks' gestation)

Adverse events

Record adverse events

Time frame: Visit 4 (40 days after delivery)