Идёт набор 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

Без фазы С лечением Healthy Participants

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Consumption 500 ml of A1 milk., Consumption 500 ml of A2 milk, Consumption 500 ml of oat drink..
Кому может быть актуально: Состояния в реестре: Healthy Participants. Базовые параметры: 30 лет — 60 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Польша
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Вмешательства

Другое 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.
Другое 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.
Другое 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.

Первичные конечные точки

Change from Baseline in Bone Mineral Density (BMD) [Срок оценки: Baseline, and after 4, 8 and 12 weeks of intervention.]

Вторичные конечные точки (12)

Change from Baseline in Plasma Procollagen Type 1 N-terminal Propeptide (P1NP) Concentration [Срок оценки: Baseline, and after 12 weeks of intervention.]
Change from Baseline in Bone Alkaline Phosphatase (BALP) Concentration [Срок оценки: Baseline, and after 12 weeks of intervention.]
Change from Baseline in Plasma C-terminal Telopeptide of Type 1 Collagen (CTX-1) Concentration [Срок оценки: Baseline, and after 12 weeks of intervention.]
Change from Baseline in Urinary Calcium Concentration [Срок оценки: Baseline, and after 12 weeks of intervention.]
Change from Baseline in Urinary Deoxypyridinoline Concentration [Срок оценки: Baseline, and after 12 weeks of intervention.]
Change from Baseline in Plasma Calcium Concentration [Срок оценки: Baseline, and after 12 weeks of intervention.]
Change from Baseline in 1,25-dihydroxyvitamin D3 [1,25(OH)2D3] Concentration [Срок оценки: Baseline, and after 12 weeks of intervention.]
Change from Baseline in Body Mass Index (BMI) [Срок оценки: Baseline, and after 4, 8 and 12 weeks of intervention.]
Change from Baseline in Waist-Hip Ratio (WHR) [Срок оценки: Baseline, and after 4, 8 and 12 weeks of intervention.]
Change from Baseline in Waist-to-Height Ratio (WHtR) [Срок оценки: Baseline, and after 4, 8 and 12 weeks of intervention.]
Change from Baseline in Ankle-Brachial Index (ABI) [Срок оценки: Baseline, and after 12 weeks of intervention.]
Change from Baseline in Body Fat Mass [Срок оценки: Baseline, and after 4, 8 and 12 weeks of intervention.]

Критерии участия

Критерии включения

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.

Критерии исключения

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: