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

24 de junho de 2026 atualizado 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.

Visão geral do estudo

Status

Ainda não está recrutando

Descrição detalhada

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 estudo

Intervencional

Inscrição (Estimado)

16

Estágio

  • Não aplicável

Contactos e Locais

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Contato de estudo

Estude backup de contato

Locais de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto

Aceita Voluntários Saudáveis

Sim

Descrição

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)

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Ciência básica
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição cruzada
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: 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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Six-hour postprandial plasma total amino acid availability following ingestion of 25 grams of different protein isolates in healthy, young adults
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
Plasma essential amino acid concentrations
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: During the six-hour postprandial period
Postprandial glucacon-like peptide-1 (GLP-1) concentrations
During the six-hour postprandial period

Colaboradores e Investigadores

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Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

15 de setembro de 2026

Conclusão Primária (Estimado)

15 de julho de 2027

Conclusão do estudo (Estimado)

15 de julho de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

24 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

24 de junho de 2026

Primeira postagem (Real)

30 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

30 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

24 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

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

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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