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Recruiting NCT07436260

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

No phase Interventional Healthy Participants

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Consumption 500 ml of A1 milk., Consumption 500 ml of A2 milk, Consumption 500 ml of oat drink..
Who it may be relevant to
Registry conditions: Healthy Participants. Basic parameters: 30 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

Interventions

  • Other 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 Consumption 500 ml of A2 milk
    The intervention study consisted of the consumption 500 ml of an appropriate product: A2 milk - daily for a 12 weeks.
  • Other 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.

Primary outcome measures

  • Change from Baseline in Bone Mineral Density (BMD) [Time frame: Baseline, and after 4, 8 and 12 weeks of intervention.]
Secondary outcome measures (12)
  • 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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Basic science

Study locations

Poland · 1 center
  • Warsaw Univeristy of Life Science — Warsaw

Identifiers

NCT: NCT07436260 · IMPA-CT/38/RKE/2024 · SUP-RIM (MEiN/2023/DPI/2866)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗