Milk Free From A1-Type β-Casein on Inflammation, Gastrointestinal Tolerance, and Pregnancy
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' gestati
| Condition(s) | Healthy Pregnant Women |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | 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 pro |
| Ages | 20 Years to 35 Years |
| Sex | Female |
| Accepts healthy volunteers | Yes |
| Lead sponsor | a2 Milk Company Ltd. |
| Locations | Foshan, Guangdong, China; Guangzhou, Guangdong, China; Wuxi, Jiangsu, China; Wuxi, Jiangsu, China; Xuzhou, Jiangsu, China; Chengdu, Sichuan, China |
| Start date | 2025-08-25 |
| NCT ID | NCT06980376 |
| Official listing | https://clinicaltrials.gov/study/NCT06980376 |