NCT07436260 Effect of the Consumption of Milk With Beta-casein A2A2, Milk With Beta-casein A1A2 and a Plant-based Drink on Metabolic Health in Adults: IMPA-CT Study
| NCT ID | NCT07436260 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Dawid Madej |
| Condition | Healthy Participants |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-09-05 |
| Primary Completion | 2026-04-23 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2025-09-05 with a primary completion date of 2026-04-23.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study was to identify and compare the effects of daily consumption of A2 milk, conventional milk, and an oat drink on bone health, cardiometabolic health, and immune system function in adults. Although cow's milk plays an important role in human nutrition, its proteins-particularly β-caseins-exhibit significant genetic diversity. Conventional milk typically contains a mix of A1 and A2 β-casein variants, whereas A2 milk contains exclusively the A2/A2 variant. The key difference between the two lies in a single amino acid at position 67: variant A1 contains histidine, which allows digestive enzymes to release the opioid peptide β-casomorphin-7 (BCM-7), while variant A2 contains proline, which prevents the release of this peptide. Consequently, the study is trying to answer the question of whether 12 weeks of consuming 500 ml of A2 milk daily-thereby eliminating dietary exposure to BCM-7-results in different outcomes for bone health (the primary measure), as well as for cardiometabolic health and immune function, when compared to consuming conventional milk or a plant-based oat drink in healthy adults aged 30-60.
Eligibility Criteria
Inclusion Criteria: * aged 30 to 60 years, * body mass index \>18.5 or \<30 kg/m2, * no diagnosed chronic disease, i.e. diabetes, cancer, kidney disease, * not taking medications/dietary supplements that may affect carbohydrate and/or lipid metabolism. Exclusion Criteria: * pregnancy or lactation in women, * implanted medical materials such as: pacemaker, defibrillator, stent, metal suture in the heart or blood vessel, and implants, * previous radiotherapy and/or chemotherapy, * significantly modified diet (e.g., ketogenic, vegetarian, or ovo-vegetarian) and health condition requiring a specialist diet, * unable to give informed consent, * unable or unwilling to comply with the study procedures, * have medical history of gastrointestinal surgery or disorders (inflammatory bowel disease, ulcerative colitis, coeliac disease, Crohn's disease), cardiorespiratory problems, uncontrolled diabetes mellitus, bleeding disorders. Non-exclusion criteria: * hypertension, or depression that are well-controlled with medical intervention.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07436260 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 60 Years, studying Healthy Participants. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07436260 currently recruiting?
Yes, NCT07436260 is actively recruiting participants. Contact the research team at jadwiga_hamulka@sggw.edu.pl for enrollment information.
Where is the NCT07436260 trial being conducted?
This trial is being conducted at Warsaw, Poland.
Who is sponsoring the NCT07436260 clinical trial?
NCT07436260 is sponsored by Dawid Madej. The trial plans to enroll 150 participants.