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Effects of Protein Type and Mineral Form on Amino Acid Availability (ProMin)

24 de junio de 2026 actualizado por: Maastricht University Medical Center

Effects of Protein Type and Mineral Form on Postprandial Amino Acid Availability in Healthy Young Adults: a Randomized Cross-over Study

To compare postprandial plasma amino acid availability, expressed as incremental area under the curve (iAUC), over a 6 hour period following ingestion of 25 g of different protein isolates in healthy, young adults. The primary objective is divided into the following 2 sub-studies, each with 3 comparisons:

  • Sub-study 1: whey protein, calcium caseinate, sodium caseinate.
  • Sub-study 2: calcium caseinate, magnesium caseinate, potassium caseinate.

Descripción general del estudio

Estado

Aún no reclutando

Intervención / Tratamiento

Descripción detallada

All living tissues are in a constant state of protein turnover, with synthesis and breakdown processes ensuring structural integrity, metabolic flexibility and the capacity for repair. Amino acids are the building blocks of proteins and must be supplied through the diet to maintain a positive protein balance. Ingestion of high-quality protein sources (e.g. meat, dairy) leads to a postprandial increase in circulating amino acids, and as such can facilitate tissue protein synthesis. The magnitude and the kinetics of the amino acid response largely depend on the amino acid composition combined with protein digestion and amino acid absorption rate.

Beyond their structural role, amino acids also function as signalling molecules involved in gastrointestinal hormone secretion and appetite control. One such key hormone is glucagon-like peptide 1 (GLP-1), a gut-derived hormone that plays an essential role in metabolic regulation such as insulin secretion and appetite suppression. Given its role in metabolic health, particularly in the context of obesity and type 2 diabetes, increasing GLP-1 availability has become a target for support in metabolic care. However, many pharmacological approaches to elevate GLP-1 are costly and carry risks of harmful side-effects.

Nutritional strategies that modulate GLP-1 secretion and availability therefore offer an attractive alternative. Emerging evidence suggests that not only protein ingestion itself, but also the matrix in which the protein is delivered can modulate GLP-1 secretion. For example, co- ingestion of specific minerals, especially calcium, has been shown to enhance GLP-1 secretion beyond the effects of protein ingestion alone. These data indicate that mineral-protein interactions may play a meaningful role in appetite regulation and metabolic signalling, warranting further investigation.

Bovine milk contains two primary high-quality protein fractions: whey (~20%) and casein (~80 %). Whey protein is rapidly digested, resulting in fast but transient increases in circulating amino acids, whereas casein protein is digested more slowly, leading to more prolonged but sustained amino acid availability (13-15). To optimize the functional properties of casein, various processing techniques can be applied, including the formation of caseinate salts through binding casein with different minerals such as calcium, sodium, magnesium, and potassium. These caseinate forms differ in mineral composition, which may influence not only digestion and absorption kinetics, but also GLP-1 secretion capacity. Although the differences in digestion kinetics between whey and casein are well-established, a direct comparison of postprandial amino acid and GLP-1 responses following ingestion of whey versus various mineral-bound caseinates has not yet been performed.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

16

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

Sí

Descripción

To be eligible to participate in this study, a participant must meet all of the following criteria:

  • Male or female sex
  • Aged between 18 - 35 years inclusive
  • BMI between 18 - 30 kg/m2
  • Healthy, recreationally active (exercise at least once per two weeks and a maximum of four days per week)
  • No physical limitations (i.e., able to perform all activities associated with daily living independently)

A potential participant who meets any of the following criteria will be excluded from participation in this study:

  • Intolerant to milk protein and/or dairy-based products
  • Smoking regularly
  • Diagnosed with gastro-intestinal disorders
  • Diagnosed with metabolic disorders (e.g. diabetes)
  • Diagnosed with musculoskeletal disorders
  • Blood donation in the past 2 months
  • Females: pregnancy
  • Use of any medication known to affect protein metabolism (e.g. corticosteroids, non-steroidal anti-inflammatories or prescribed acne medications)
  • Chronic use of gastric acid suppressing drugs (e.g. proton pump inhibitors, H2-antagonists)

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Ciencia básica
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación cruzada
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Whey protein
25 g whey protein isolate
25 g protein isolate, dissolved in 500 mL water
Experimental: Sodium caseinate
25 g sodium caseinate protein
25 g protein isolate, dissolved in 500 mL water
Experimental: Calcium caseinate
25 g calcium caseinate protein
25 g protein isolate, dissolved in 500 mL water
Experimental: Magnesium caseinate
25 g magnesium caseinate protein
25 g protein isolate, dissolved in 500 mL water
Experimental: Potassium caseinate
25 g potassium caseinate protein
25 g protein isolate, dissolved in 500 mL water

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Six-hour postprandial plasma total amino acid availability following ingestion of 25 grams of different protein isolates in healthy, young adults
Periodo de tiempo: Six hours
Plasma total amino acid availability is expressed as the incremental area under the curve (iAUC) and compared between whey protein, calcium caseinate and sodium caseinate (sub-study 1) and between calcium caseinate, magnesium caseinate and potassium caseinate (sub-study 2).
Six hours

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Plasma essential amino acid concentrations
Periodo de tiempo: Essential amino acid concentrations are derived from blood samples taken before beverage ingestion and during the six-hour postprandial time-period (at 15, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 300 and 360 minutes following beverage ingestion).
The summed measurement of histidine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan and valine concentrations
Essential amino acid concentrations are derived from blood samples taken before beverage ingestion and during the six-hour postprandial time-period (at 15, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 300 and 360 minutes following beverage ingestion).
Non-essential amino acid concentrations
Periodo de tiempo: Nonssential amino acid concentrations are derived from blood samples taken before beverage ingestion and during the six-hour postprandial time-period (at 15, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 300 and 360 minutes following beverage ingestion).
The summed measurement of alanine, arginine, aspartic acid, cysteine, glutamic acid, glycine, serine, tyrosine and valine concentrations
Nonssential amino acid concentrations are derived from blood samples taken before beverage ingestion and during the six-hour postprandial time-period (at 15, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 300 and 360 minutes following beverage ingestion).
Plasma amino acid kinetics
Periodo de tiempo: During the six-hour postprandial period
Compare peak plasma amino acid concentrations and the time to reach these peak concentrations of all individually measured amino acids
During the six-hour postprandial period
Circulating mineral concentrations
Periodo de tiempo: During the six-hour postprandial period
Calcium, magnesium, sodium, potassium and parathyroid hormone concentrations
During the six-hour postprandial period
Glucagon-like peptide-1 concentrations
Periodo de tiempo: During the six-hour postprandial period
Postprandial glucacon-like peptide-1 (GLP-1) concentrations
During the six-hour postprandial period

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

15 de septiembre de 2026

Finalización primaria (Estimado)

15 de julio de 2027

Finalización del estudio (Estimado)

15 de julio de 2027

Fechas de registro del estudio

Enviado por primera vez

24 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

24 de junio de 2026

Publicado por primera vez (Actual)

30 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

30 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

24 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • METC 26-007
  • NL-011398 (Otro identificador: CCMO)

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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