Healthy ParticipantsIMPA-CTNCT07436260
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
A study testing Consumption 500 ml of A1 milk., Consumption 500 ml of A2 milk and Consumption 500 ml of oat drink. in people with Healthy Participants, run by Dawid Madej at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Consumption 500 ml of A1 milk., Consumption 500 ml of A2 milk and Consumption 500 ml of oat drink.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 sitePoland
- Study dates
- 5 Sep 2025to 23 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Warsaw Univeristy of Life Science
Warsaw, Masovian Voivodeship, 02-776
Jadwiga Hamulka Prof. dr hab., Prof. dr hab., 048 22 59 37 112, jadwiga_hamulka@sggw.edu.pl
About this study
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
- Being tested
- Consumption 500 ml of A1 milk., Consumption 500 ml of A2 milk, Consumption 500 ml of oat drink.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Consumption 500 ml of A2 milkOther
The intervention study consisted of the consumption 500 ml of an appropriate product: A2 milk - daily for a 12 weeks.
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.
| Study group | Role | What they receive |
|---|---|---|
| A2 Milk Group | Experimental | Habitual diet supplemented with 500 mL of milk A2 daily for 12 weeks; product available on the market Receives: 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 Receives: 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 Receives: Other: Consumption 500 ml of oat drink. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Bone Mineral Density (BMD)
Assessment of changes in bone mineral density (BMD) using Dual-energy X-ray Absorptiometry (DEXA).
Measured: 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
Assessment of changes in P1NP as a biochemical marker of bone formation.
Measured: Baseline, and after 12 weeks of intervention.
Change from Baseline in Bone Alkaline Phosphatase (BALP) Concentration
Assessment of changes in BALP as a biochemical marker of bone formation.
Measured: Baseline, and after 12 weeks of intervention.
Change from Baseline in Plasma C-terminal Telopeptide of Type 1 Collagen (CTX-1) Concentration
Assessment of changes in plasma CTX-1 as a biochemical marker of bone resorption.
Measured: Baseline, and after 12 weeks of intervention.
Change from Baseline in Urinary Calcium Concentration
Assessment of changes in urinary calcium levels as a marker of bone resorption.
Measured: Baseline, and after 12 weeks of intervention.
Change from Baseline in Urinary Deoxypyridinoline Concentration
Assessment of changes in urinary deoxypyridinoline levels as a marker of bone resorption.
Measured: Baseline, and after 12 weeks of intervention.
Change from Baseline in Plasma Calcium Concentration
Assessment of changes in plasma calcium levels as a marker of bone homeostasis.
Measured: Baseline, and after 12 weeks of intervention.
Change from Baseline in 1,25-dihydroxyvitamin D3 [1,25(OH)2D3] Concentration
Assessment of changes in 1,25(OH)2D3 levels as a marker of bone homeostasis.
Measured: Baseline, and after 12 weeks of intervention.
Change from Baseline in Body Mass Index (BMI)
Weight and height will be combined to report BMI in kg/m^2.
Measured: Baseline, and after 4, 8 and 12 weeks of intervention.
Change from Baseline in Waist-Hip Ratio (WHR)
Assessment of fat distribution calculated as waist measurement divided by hip measurement (unitless ratio).
Measured: Baseline, and after 4, 8 and 12 weeks of intervention.
Change from Baseline in Waist-to-Height Ratio (WHtR)
Assessment of fat distribution calculated as waist measurement divided by height (unitless ratio).
Measured: Baseline, and after 4, 8 and 12 weeks of intervention.
Change from Baseline in Ankle-Brachial Index (ABI)
Assessment of cardiovascular health using blood pressure measurements to calculate the Ankle-Brachial Index (ABI).
Measured: Baseline, and after 12 weeks of intervention.
Change from Baseline in Body Fat Mass
Assessment of changes in body fat mass, assessed by BIA and DEXA. Results will be reported in kilograms (kg).
Measured: Baseline, and after 4, 8 and 12 weeks of intervention.
Change from Baseline in Body Fat Percentage
Assessment of changes in total body fat content, assessed by BIA and DEXA. Results will be reported as a percentage (%).
Measured: Baseline, and after 4, 8 and 12 weeks of intervention.
Change from Baseline in Visceral Fat Area
Assessment of changes in visceral fat assessed by BIA and DEXA. Results will be reported in square centimeters (cm^2).
Measured: Baseline, and after 4, 8 and 12 weeks of intervention.
Change from Baseline in Cholesterol Concentration
Assessment of changes in total cholesterol, High-Density Lipoprotein (HDL) and Low-Density Lipoprotein (LDL) Cholesterol Concentration as part of the lipid profile.
Measured: Baseline, and after 12 weeks of intervention.
Change from Baseline in Triglycerides Concentration
Assessment of changes in triglycerides as part of the lipid profile.
Measured: Baseline, and after 12 weeks of intervention.
Change from Baseline in Fasting Glucose Concentration
Assessment of changes in fasting blood glucose levels.
Measured: Baseline, and after 12 weeks of intervention.
Change from Baseline in Fasting Insulin Concentration
Assessment of changes in fasting insulin levels.
Measured: Baseline, and after 12 weeks of intervention.
Change from Baseline in Insulin-like Growth Factor-1 (IGF-1) Concentration
Assessment of changes in IGF-1 levels.
Measured: Baseline, and after 12 weeks of intervention.
Change from Baseline in IGF-Binding Protein-3 (IGFBP-3) Concentration
Assessment of changes in IGFBP-3 levels.
Measured: Baseline, and after 12 weeks of intervention.
Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP) Concentration
Assessment of changes in hsCRP as a marker of systemic inflammation.
Measured: Baseline, and after 12 weeks of intervention.
Change from Baseline in Uric Acid Concentration at 12 Weeks
Assessment of changes in uric acid levels.
Measured: Baseline, and after 12 weeks of intervention.
Change from Baseline in Creatinine Concentration
Assessment of changes in creatinine levels.
Measured: Baseline, and after 12 weeks of intervention.
Baseline, and after 12 weeks of intervention.
Assessment of changes in plasma levels of Immunoglobulin A (IgA) as an indicator of immune system functioning.
Measured: Baseline, and after 12 weeks of intervention.
Change from Baseline in Immunoglobulin G (IgG) Concentration
Assessment of changes in plasma levels of Immunoglobulin G (IgG) as an indicator of immune system functioning.
Measured: Baseline, and after 12 weeks of intervention.
Change from Baseline in Allergen-specific Immunoglobulin E (sIgE) Concentration
Assessment of changes in allergen-specific Immunoglobulin E (sIgE) as a marker for potential casein allergy.
Measured: Baseline, and after 12 weeks of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start5 Sep 2025
- Primary completion23 Apr 2026 (estimated)
- Study completion23 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dawid Madej
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dawid Madej, Warsaw University of Life Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07436260
- Sponsor's protocol ID
- IMPA-CT/38/RKE/2024
- Other IDs
- SUP-RIM (MEiN/2023/DPI/2866)
- Acronym
- IMPA-CT
- Status last verified
- Feb 2026
- First submitted
- 29 Jan 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07436260
- Acronym / sponsor ID
- IMPA-CT / IMPA-CT/38/RKE/2024
- Conditions
- Healthy Participants
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Dawid MadejUniversity, hospital or other
- Study start
- 5 Sep 2025 (actual)
- Primary completion
- 23 Apr 2026 (estimated)
- Study completion
- 23 Apr 2026 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A2 Milk Group | Experimental | Other: Consumption 500 ml of A2 milkHabitual diet supplemented with 500 mL of milk A2 daily for 12 weeks; product available on the market |
| A1 Milk Group | Experimental | Other: Consumption 500 ml of A1 milk.Habitual diet with 500 mL of milk A1/A2 daily for 12 weeks; product available on the market |
| Pland Drink Group | Experimental | Other: Consumption 500 ml of oat drink.Habitual diet supplemented with 500 mL of oat drink daily for 12 weeks; product available on the market |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Consumption 500 ml of A1 milk.The intervention study consisted of the consumption 500 ml of an appropriate product: A1 milk - daily for a 12 weeks. | Other | A1 Milk Group |
| Consumption 500 ml of A2 milkThe intervention study consisted of the consumption 500 ml of an appropriate product: A2 milk - daily for a 12 weeks. | Other | A2 Milk Group |
| Consumption 500 ml of oat drink.The intervention study consisted of the consumption 500 ml of an appropriate product: oat drink - daily for a 12 weeks. | Other | Pland Drink Group |
Primary outcome
Change from Baseline in Bone Mineral Density (BMD)
Time frame: Baseline, and after 4, 8 and 12 weeks of intervention.
Assessment of changes in bone mineral density (BMD) using Dual-energy X-ray Absorptiometry (DEXA).
26 secondary outcomes
Change from Baseline in Plasma Procollagen Type 1 N-terminal Propeptide (P1NP) Concentration
Time frame: Baseline, and after 12 weeks of intervention.
Change from Baseline in Bone Alkaline Phosphatase (BALP) Concentration
Time frame: Baseline, and after 12 weeks of intervention.
Change from Baseline in Plasma C-terminal Telopeptide of Type 1 Collagen (CTX-1) Concentration
Time frame: Baseline, and after 12 weeks of intervention.
Change from Baseline in Urinary Calcium Concentration
Time frame: Baseline, and after 12 weeks of intervention.
Change from Baseline in Urinary Deoxypyridinoline Concentration
Time frame: Baseline, and after 12 weeks of intervention.
Change from Baseline in Plasma Calcium Concentration
Time frame: Baseline, and after 12 weeks of intervention.
Change from Baseline in 1,25-dihydroxyvitamin D3 [1,25(OH)2D3] Concentration
Time frame: Baseline, and after 12 weeks of intervention.
Change from Baseline in Body Mass Index (BMI)
Time frame: Baseline, and after 4, 8 and 12 weeks of intervention.
Change from Baseline in Waist-Hip Ratio (WHR)
Time frame: Baseline, and after 4, 8 and 12 weeks of intervention.
Change from Baseline in Waist-to-Height Ratio (WHtR)
Time frame: Baseline, and after 4, 8 and 12 weeks of intervention.
Change from Baseline in Ankle-Brachial Index (ABI)
Time frame: Baseline, and after 12 weeks of intervention.
Change from Baseline in Body Fat Mass
Time frame: Baseline, and after 4, 8 and 12 weeks of intervention.
Change from Baseline in Body Fat Percentage
Time frame: Baseline, and after 4, 8 and 12 weeks of intervention.
Change from Baseline in Visceral Fat Area
Time frame: Baseline, and after 4, 8 and 12 weeks of intervention.
Change from Baseline in Cholesterol Concentration
Time frame: Baseline, and after 12 weeks of intervention.
Change from Baseline in Triglycerides Concentration
Time frame: Baseline, and after 12 weeks of intervention.
Change from Baseline in Fasting Glucose Concentration
Time frame: Baseline, and after 12 weeks of intervention.
Change from Baseline in Fasting Insulin Concentration
Time frame: Baseline, and after 12 weeks of intervention.
Change from Baseline in Insulin-like Growth Factor-1 (IGF-1) Concentration
Time frame: Baseline, and after 12 weeks of intervention.
Change from Baseline in IGF-Binding Protein-3 (IGFBP-3) Concentration
Time frame: Baseline, and after 12 weeks of intervention.
Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP) Concentration
Time frame: Baseline, and after 12 weeks of intervention.
Change from Baseline in Uric Acid Concentration at 12 Weeks
Time frame: Baseline, and after 12 weeks of intervention.
Change from Baseline in Creatinine Concentration
Time frame: Baseline, and after 12 weeks of intervention.
Baseline, and after 12 weeks of intervention.
Time frame: Baseline, and after 12 weeks of intervention.
Change from Baseline in Immunoglobulin G (IgG) Concentration
Time frame: Baseline, and after 12 weeks of intervention.
Change from Baseline in Allergen-specific Immunoglobulin E (sIgE) Concentration
Time frame: Baseline, and after 12 weeks of intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Consumption 500 ml of A1 milk., Consumption 500 ml of A2 milk and Consumption 500 ml of oat drink. in people with Healthy Participants, run by Dawid Madej at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jadwiga Hamulka Prof. dr hab., Prof. dr hab. ((48)0225937112, jadwiga_hamulka@sggw.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Bone Mineral Density (BMD) (time frame: Baseline, and after 4, 8 and 12 weeks of intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.