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| ID | Type | Description | Link |
|---|---|---|---|
| SUP-RIM (MEiN/2023/DPI/2866) | Other Grant/Funding Number | Ministry of Science and Higher Education of Poland |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A2 Milk Group | Experimental | Habitual diet supplemented with 500 mL of milk A2 daily for 12 weeks; product available on the market |
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| A1 Milk Group | Experimental | Habitual diet with 500 mL of milk A1/A2 daily for 12 weeks; product available on the market |
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| Pland Drink Group | Experimental | Habitual diet supplemented with 500 mL of oat drink daily for 12 weeks; product available on the market |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, and after 12 weeks of intervention. |
| Change from Baseline in Bone Alkaline Phosphatase (BALP) Concentration |
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Inclusion Criteria:
Exclusion Criteria:
Non-exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jadwiga Hamulka Prof. dr hab., Prof. dr hab. | Contact | (48)0225937112 | jadwiga_hamulka@sggw.edu.pl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Warsaw Univeristy of Life Science | Recruiting | Warsaw | Masovian Voivodeship | 02-776 | Poland |
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| 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. |
|
| 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. |
|
Assessment of changes in BALP as a biochemical marker of bone formation. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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). | 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). | 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). | 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 (%). | 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). | 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. | Baseline, and after 12 weeks of intervention. |
| Change from Baseline in Triglycerides Concentration | Assessment of changes in triglycerides as part of the lipid profile. | Baseline, and after 12 weeks of intervention. |
| Change from Baseline in Fasting Glucose Concentration | Assessment of changes in fasting blood glucose levels. | Baseline, and after 12 weeks of intervention. |
| Change from Baseline in Fasting Insulin Concentration | Assessment of changes in fasting insulin levels. | 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. | 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. | 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. | Baseline, and after 12 weeks of intervention. |
| Change from Baseline in Uric Acid Concentration at 12 Weeks | Assessment of changes in uric acid levels. | Baseline, and after 12 weeks of intervention. |
| Change from Baseline in Creatinine Concentration | Assessment of changes in creatinine levels. | 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. | 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. | 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. | Baseline, and after 12 weeks of intervention. |
| ID | Term |
|---|---|
| D004467 | Economics |
| ID | Term |
|---|---|
| D004472 | Health Care Economics and Organizations |
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