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

Dawid Madej150 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

150

Conditions

Healthy Participants

Interventions

Eligibility

Sex: ALLMin age: 30 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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. Non-exclusion criteria: * hypertension, or depression that are well-controlled with medical intervention.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

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.

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts