- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Noortje Boot, MSc
- Telefonní číslo: 088-3887246
- E-mail: noortje.boot@maastrichtuniversity.nl
Studijní záloha kontaktů
- Jméno: Luc van Loon, Prof., PhD
- Telefonní číslo: 043-3881397
- E-mail: l.vanloon@maastrichtuniversity.nl
Studijní místa
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Limburg
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Maastricht, Limburg, Holandsko, 6200
- Maastricht University Medical Centre
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Kontakt:
- Luc van Loon, PhD
- Telefonní číslo: 043-3881397
- E-mail: l.vanloon@maastrichtuniversity.nl
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
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)
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Základní věda
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Aktivní komparátor: Whey protein
25 g whey protein isolate
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25 g protein isolate, dissolved in 500 mL water
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Experimentální: Sodium caseinate
25 g sodium caseinate protein
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25 g protein isolate, dissolved in 500 mL water
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Experimentální: Calcium caseinate
25 g calcium caseinate protein
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25 g protein isolate, dissolved in 500 mL water
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Experimentální: Magnesium caseinate
25 g magnesium caseinate protein
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25 g protein isolate, dissolved in 500 mL water
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Experimentální: Potassium caseinate
25 g potassium caseinate protein
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25 g protein isolate, dissolved in 500 mL water
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Six-hour postprandial plasma total amino acid availability following ingestion of 25 grams of different protein isolates in healthy, young adults
Časové okno: Six hours
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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).
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Six hours
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Plasma essential amino acid concentrations
Časové okno: 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).
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The summed measurement of histidine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan and valine concentrations
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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).
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Non-essential amino acid concentrations
Časové okno: 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).
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The summed measurement of alanine, arginine, aspartic acid, cysteine, glutamic acid, glycine, serine, tyrosine and valine concentrations
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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).
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Plasma amino acid kinetics
Časové okno: During the six-hour postprandial period
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Compare peak plasma amino acid concentrations and the time to reach these peak concentrations of all individually measured amino acids
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During the six-hour postprandial period
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Circulating mineral concentrations
Časové okno: During the six-hour postprandial period
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Calcium, magnesium, sodium, potassium and parathyroid hormone concentrations
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During the six-hour postprandial period
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Glucagon-like peptide-1 concentrations
Časové okno: During the six-hour postprandial period
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Postprandial glucacon-like peptide-1 (GLP-1) concentrations
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During the six-hour postprandial period
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Spolupracovníci a vyšetřovatelé
Spolupracovníci
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- METC 26-007
- NL-011398 (Jiný identifikátor: CCMO)
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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