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

NCT07436260 | Recruiting

• 2 other identifiers: IMPA-CT/38/RKE/2024SUP-RIM (MEiN/2023/DPI/2866)
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Bone Mineral Density (BMD)

  Assessment of changes in bone mineral density (BMD) using Dual-energy X-ray Absorptiometry (DEXA).

  Baseline, and after 4, 8 and 12 weeks of intervention.

Secondary Outcomes (26)

• Change from Baseline in Plasma Procollagen Type 1 N-terminal Propeptide (P1NP) Concentration

  Baseline, and after 12 weeks of intervention.

• Change from Baseline in Bone Alkaline Phosphatase (BALP) Concentration

  Baseline, and after 12 weeks of intervention.

• Change from Baseline in Plasma C-terminal Telopeptide of Type 1 Collagen (CTX-1) Concentration

  Baseline, and after 12 weeks of intervention.

• Change from Baseline in Urinary Calcium Concentration

  Baseline, and after 12 weeks of intervention.

• Change from Baseline in Urinary Deoxypyridinoline Concentration

  Baseline, and after 12 weeks of intervention.

Study Arms (3)

A2 Milk Group

EXPERIMENTAL

Habitual diet supplemented with 500 mL of milk A2 daily for 12 weeks; product available on the market

Other: Consumption 500 ml of A2 milk

A1 Milk Group

EXPERIMENTAL

Habitual diet with 500 mL of milk A1/A2 daily for 12 weeks; product available on the market

Other: Consumption 500 ml of A1 milk.

Pland Drink Group

EXPERIMENTAL

Habitual diet supplemented with 500 mL of oat drink daily for 12 weeks; product available on the market

Other: Consumption 500 ml of oat drink.

Interventions

Consumption 500 ml of A1 milk. OTHER

The intervention study consisted of the consumption 500 ml of an appropriate product: A1 milk - daily for a 12 weeks.

A1 Milk Group

Consumption 500 ml of A2 milk OTHER

The intervention study consisted of the consumption 500 ml of an appropriate product: A2 milk - daily for a 12 weeks.

A2 Milk Group

Consumption 500 ml of oat drink. OTHER

The intervention study consisted of the consumption 500 ml of an appropriate product: oat drink - daily for a 12 weeks.

Pland Drink Group

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• hypertension, or depression that are well-controlled with medical intervention.

Sponsors & Collaborators

• Dawid Madej: lead

Study Sites (1)

Warsaw Univeristy of Life Science

Warsaw, Masovian Voivodeship, 02-776, Poland

RECRUITING

MeSH Terms

Interventions

Economics

Intervention Hierarchy (Ancestors)

Health Care Economics and Organizations

Central Study Contacts

Jadwiga Hamulka Prof. dr hab., Prof. dr hab.

CONTACT

(48)0225937112; jadwiga_hamulka@sggw.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 27, 2026
• Study Start: September 5, 2025
• Primary Completion: April 23, 2026
• Study Completion: April 23, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)