Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 1:15 PM
Study NCT ID:
NCT07436260
Status:
RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief 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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004467', 'term': 'Economics'}], 'ancestors': [{'id': 'D004472', 'term': 'Health Care Economics and Organizations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-04-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-20', 'studyFirstSubmitDate': '2026-01-29', 'studyFirstSubmitQcDate': '2026-02-20', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in Bone Mineral Density (BMD)', 'timeFrame': 'Baseline, and after 4, 8 and 12 weeks of intervention.', 'description': 'Assessment of changes in bone mineral density (BMD) using Dual-energy X-ray Absorptiometry (DEXA).'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in Plasma Procollagen Type 1 N-terminal Propeptide (P1NP) Concentration', 'timeFrame': 'Baseline, and after 12 weeks of intervention.', 'description': 'Assessment of changes in P1NP as a biochemical marker of bone formation.'}, {'measure': 'Change from Baseline in Bone Alkaline Phosphatase (BALP) Concentration', 'timeFrame': 'Baseline, and after 12 weeks of intervention.', 'description': 'Assessment of changes in BALP as a biochemical marker of bone formation.'}, {'measure': 'Change from Baseline in Plasma C-terminal Telopeptide of Type 1 Collagen (CTX-1) Concentration', 'timeFrame': 'Baseline, and after 12 weeks of intervention.', 'description': 'Assessment of changes in plasma CTX-1 as a biochemical marker of bone resorption.'}, {'measure': 'Change from Baseline in Urinary Calcium Concentration', 'timeFrame': 'Baseline, and after 12 weeks of intervention.', 'description': 'Assessment of changes in urinary calcium levels as a marker of bone resorption.'}, {'measure': 'Change from Baseline in Urinary Deoxypyridinoline Concentration', 'timeFrame': 'Baseline, and after 12 weeks of intervention.', 'description': 'Assessment of changes in urinary deoxypyridinoline levels as a marker of bone resorption.'}, {'measure': 'Change from Baseline in Plasma Calcium Concentration', 'timeFrame': 'Baseline, and after 12 weeks of intervention.', 'description': 'Assessment of changes in plasma calcium levels as a marker of bone homeostasis.'}, {'measure': 'Change from Baseline in 1,25-dihydroxyvitamin D3 [1,25(OH)2D3] Concentration', 'timeFrame': 'Baseline, and after 12 weeks of intervention.', 'description': 'Assessment of changes in 1,25(OH)2D3 levels as a marker of bone homeostasis.'}, {'measure': 'Change from Baseline in Body Mass Index (BMI)', 'timeFrame': 'Baseline, and after 4, 8 and 12 weeks of intervention.', 'description': 'Weight and height will be combined to report BMI in kg/m\\^2.'}, {'measure': 'Change from Baseline in Waist-Hip Ratio (WHR)', 'timeFrame': 'Baseline, and after 4, 8 and 12 weeks of intervention.', 'description': 'Assessment of fat distribution calculated as waist measurement divided by hip measurement (unitless ratio).'}, {'measure': 'Change from Baseline in Waist-to-Height Ratio (WHtR)', 'timeFrame': 'Baseline, and after 4, 8 and 12 weeks of intervention.', 'description': 'Assessment of fat distribution calculated as waist measurement divided by height (unitless ratio).'}, {'measure': 'Change from Baseline in Ankle-Brachial Index (ABI)', 'timeFrame': 'Baseline, and after 12 weeks of intervention.', 'description': 'Assessment of cardiovascular health using blood pressure measurements to calculate the Ankle-Brachial Index (ABI).'}, {'measure': 'Change from Baseline in Body Fat Mass', 'timeFrame': 'Baseline, and after 4, 8 and 12 weeks of intervention.', 'description': 'Assessment of changes in body fat mass, assessed by BIA and DEXA. Results will be reported in kilograms (kg).'}, {'measure': 'Change from Baseline in Body Fat Percentage', 'timeFrame': 'Baseline, and after 4, 8 and 12 weeks of intervention.', 'description': 'Assessment of changes in total body fat content, assessed by BIA and DEXA. Results will be reported as a percentage (%).'}, {'measure': 'Change from Baseline in Visceral Fat Area', 'timeFrame': 'Baseline, and after 4, 8 and 12 weeks of intervention.', 'description': 'Assessment of changes in visceral fat assessed by BIA and DEXA. Results will be reported in square centimeters (cm\\^2).'}, {'measure': 'Change from Baseline in Cholesterol Concentration', 'timeFrame': 'Baseline, and after 12 weeks of intervention.', 'description': 'Assessment of changes in total cholesterol, High-Density Lipoprotein (HDL) and Low-Density Lipoprotein (LDL) Cholesterol Concentration as part of the lipid profile.'}, {'measure': 'Change from Baseline in Triglycerides Concentration', 'timeFrame': 'Baseline, and after 12 weeks of intervention.', 'description': 'Assessment of changes in triglycerides as part of the lipid profile.'}, {'measure': 'Change from Baseline in Fasting Glucose Concentration', 'timeFrame': 'Baseline, and after 12 weeks of intervention.', 'description': 'Assessment of changes in fasting blood glucose levels.'}, {'measure': 'Change from Baseline in Fasting Insulin Concentration', 'timeFrame': 'Baseline, and after 12 weeks of intervention.', 'description': 'Assessment of changes in fasting insulin levels.'}, {'measure': 'Change from Baseline in Insulin-like Growth Factor-1 (IGF-1) Concentration', 'timeFrame': 'Baseline, and after 12 weeks of intervention.', 'description': 'Assessment of changes in IGF-1 levels.'}, {'measure': 'Change from Baseline in IGF-Binding Protein-3 (IGFBP-3) Concentration', 'timeFrame': 'Baseline, and after 12 weeks of intervention.', 'description': 'Assessment of changes in IGFBP-3 levels.'}, {'measure': 'Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP) Concentration', 'timeFrame': 'Baseline, and after 12 weeks of intervention.', 'description': 'Assessment of changes in hsCRP as a marker of systemic inflammation.'}, {'measure': 'Change from Baseline in Uric Acid Concentration at 12 Weeks', 'timeFrame': 'Baseline, and after 12 weeks of intervention.', 'description': 'Assessment of changes in uric acid levels.'}, {'measure': 'Change from Baseline in Creatinine Concentration', 'timeFrame': 'Baseline, and after 12 weeks of intervention.', 'description': 'Assessment of changes in creatinine levels.'}, {'measure': 'Baseline, and after 12 weeks of intervention.', 'timeFrame': 'Baseline, and after 12 weeks of intervention.', 'description': 'Assessment of changes in plasma levels of Immunoglobulin A (IgA) as an indicator of immune system functioning.'}, {'measure': 'Change from Baseline in Immunoglobulin G (IgG) Concentration', 'timeFrame': 'Baseline, and after 12 weeks of intervention.', 'description': 'Assessment of changes in plasma levels of Immunoglobulin G (IgG) as an indicator of immune system functioning.'}, {'measure': 'Change from Baseline in Allergen-specific Immunoglobulin E (sIgE) Concentration', 'timeFrame': 'Baseline, and after 12 weeks of intervention.', 'description': 'Assessment of changes in allergen-specific Immunoglobulin E (sIgE) as a marker for potential casein allergy.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Participants']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* aged 30 to 60 years,\n* body mass index \\>18.5 or \\<30 kg/m2,\n* no diagnosed chronic disease, i.e. diabetes, cancer, kidney disease,\n* not taking medications/dietary supplements that may affect carbohydrate and/or lipid metabolism.\n\nExclusion Criteria:\n\n* pregnancy or lactation in women,\n* implanted medical materials such as: pacemaker, defibrillator, stent, metal suture in the heart or blood vessel, and implants,\n* previous radiotherapy and/or chemotherapy,\n* significantly modified diet (e.g., ketogenic, vegetarian, or ovo-vegetarian) and health condition requiring a specialist diet,\n* unable to give informed consent,\n* unable or unwilling to comply with the study procedures,\n* 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.\n\nNon-exclusion criteria:\n\n* hypertension, or depression that are well-controlled with medical intervention."}, 'identificationModule': {'nctId': 'NCT07436260', 'acronym': 'IMPA-CT', 'briefTitle': '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', 'organization': {'class': 'OTHER', 'fullName': 'Warsaw University of Life Sciences'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'IMPA-CT/38/RKE/2024'}, 'secondaryIdInfos': [{'id': 'SUP-RIM (MEiN/2023/DPI/2866)', 'type': 'OTHER_GRANT', 'domain': 'Ministry of Science and Higher Education of Poland'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A2 Milk Group', 'description': 'Habitual diet supplemented with 500 mL of milk A2 daily for 12 weeks; product available on the market', 'interventionNames': ['Other: Consumption 500 ml of A2 milk']}, {'type': 'EXPERIMENTAL', 'label': 'A1 Milk Group', 'description': 'Habitual diet with 500 mL of milk A1/A2 daily for 12 weeks; product available on the market', 'interventionNames': ['Other: Consumption 500 ml of A1 milk.']}, {'type': 'EXPERIMENTAL', 'label': 'Pland Drink Group', 'description': 'Habitual diet supplemented with 500 mL of oat drink daily for 12 weeks; product available on the market', 'interventionNames': ['Other: Consumption 500 ml of oat drink.']}], 'interventions': [{'name': 'Consumption 500 ml of A1 milk.', 'type': 'OTHER', 'description': 'The intervention study consisted of the consumption 500 ml of an appropriate product: A1 milk - daily for a 12 weeks.', 'armGroupLabels': ['A1 Milk Group']}, {'name': 'Consumption 500 ml of A2 milk', 'type': 'OTHER', 'description': 'The intervention study consisted of the consumption 500 ml of an appropriate product: A2 milk - daily for a 12 weeks.', 'armGroupLabels': ['A2 Milk Group']}, {'name': 'Consumption 500 ml of oat drink.', 'type': 'OTHER', 'description': 'The intervention study consisted of the consumption 500 ml of an appropriate product: oat drink - daily for a 12 weeks.', 'armGroupLabels': ['Pland Drink Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02-776', 'city': 'Warsaw', 'state': 'Masovian Voivodeship', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Jadwiga Hamulka Prof. dr hab., Prof. dr hab.', 'role': 'CONTACT', 'email': 'jadwiga_hamulka@sggw.edu.pl', 'phone': '048 22 59 37 112'}], 'facility': 'Warsaw Univeristy of Life Science', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'centralContacts': [{'name': 'Jadwiga Hamulka Prof. dr hab., Prof. dr hab.', 'role': 'CONTACT', 'email': 'jadwiga_hamulka@sggw.edu.pl', 'phone': '(48)0225937112'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dawid Madej', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dawid Madej', 'investigatorAffiliation': 'Warsaw University of Life Sciences'}}}}