An interventional study of Consumption 500 ml of A1 milk. and Consumption 500 ml of A2 milk in Healthy Participants, sponsored by Dawid Madej. Recruiting at 1 site in Poland. Open to participants aged 30 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-27.
Sponsored by Dawid Madej · Not applicable, Interventional, and Basic science
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.
This is the only study on the registry with Dawid Madej as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Non-exclusion criteria:
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
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.
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.
The intervention study consisted of the consumption 500 ml of an appropriate product: A1 milk - daily for a 12 weeks.
The intervention study consisted of the consumption 500 ml of an appropriate product: A2 milk - daily for a 12 weeks.
The intervention study consisted of the consumption 500 ml of an appropriate product: oat drink - daily for a 12 weeks.
Change from Baseline in Bone Mineral Density (BMD)
Assessment of changes in bone mineral density (BMD) using Dual-energy X-ray Absorptiometry (DEXA).
Time frame: Baseline, and after 4, 8 and 12 weeks of intervention.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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 (%).
Time frame: 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).
Time frame: 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.
Time frame: Baseline, and after 12 weeks of intervention.
Change from Baseline in Triglycerides Concentration
Assessment of changes in triglycerides as part of the lipid profile.
Time frame: Baseline, and after 12 weeks of intervention.
Change from Baseline in Fasting Glucose Concentration
Assessment of changes in fasting blood glucose levels.
Time frame: Baseline, and after 12 weeks of intervention.
Change from Baseline in Fasting Insulin Concentration
Assessment of changes in fasting insulin levels.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, and after 12 weeks of intervention.
Change from Baseline in Uric Acid Concentration at 12 Weeks
Assessment of changes in uric acid levels.
Time frame: Baseline, and after 12 weeks of intervention.
Change from Baseline in Creatinine Concentration
Assessment of changes in creatinine levels.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, and after 12 weeks of intervention.
Plan to share: No
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