- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07677098
Effects of Protein Type and Mineral Form on Amino Acid Availability (ProMin)
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Noortje Boot, MSc
- Numero di telefono: 088-3887246
- Email: noortje.boot@maastrichtuniversity.nl
Backup dei contatti dello studio
- Nome: Luc van Loon, Prof., PhD
- Numero di telefono: 043-3881397
- Email: l.vanloon@maastrichtuniversity.nl
Luoghi di studio
-
-
Limburg
-
Maastricht, Limburg, Olanda, 6200
- Maastricht University Medical Centre
-
Contatto:
- Luc van Loon, PhD
- Numero di telefono: 043-3881397
- Email: l.vanloon@maastrichtuniversity.nl
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Descrizione
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)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: Whey protein
25 g whey protein isolate
|
25 g protein isolate, dissolved in 500 mL water
|
|
Sperimentale: Sodium caseinate
25 g sodium caseinate protein
|
25 g protein isolate, dissolved in 500 mL water
|
|
Sperimentale: Calcium caseinate
25 g calcium caseinate protein
|
25 g protein isolate, dissolved in 500 mL water
|
|
Sperimentale: Magnesium caseinate
25 g magnesium caseinate protein
|
25 g protein isolate, dissolved in 500 mL water
|
|
Sperimentale: Potassium caseinate
25 g potassium caseinate protein
|
25 g protein isolate, dissolved in 500 mL water
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Six-hour postprandial plasma total amino acid availability following ingestion of 25 grams of different protein isolates in healthy, young adults
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Plasma essential amino acid concentrations
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: During the six-hour postprandial period
|
Postprandial glucacon-like peptide-1 (GLP-1) concentrations
|
During the six-hour postprandial period
|
Collaboratori e investigatori
Collaboratori
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- METC 26-007
- NL-011398 (Altro identificatore: CCMO)
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .