- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT05754125
Potentiel anabolisant in vivo et in vitro des acides aminés essentiels après un exercice de résistance (DiEx)
This study seeks to investigate the anabolic potential of a dileucine-enriched essential amino acid (EAA) formulation compared with a branched chain amino acid (BCAA) alternative and a collagen beverage on muscle protein anabolism and catabolism following a bout of resistance exercise training. To do this, investigators will employ a novel 'breath test' method developed in our laboratory as well as blood and urine sampling. The results of this study will allow us to better understand the anabolic potential of dileucine which could have implications for people engaging in regular resistance training (such as athletes) as well as people that need to preserve muscle mass (older people who are susceptible to anabolic resistance and sarcopenia, or muscle wasting).
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Ontario
-
Toronto, Ontario, Canada, M5S2C9
- Goldring Centre for High Performance Sport at the University of Toronto
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Trained individuals currently performing structured exercise (e.g., running, weightlifting, team-sport activity) at least 2 days per week for the previous 3 months
Exclusion Criteria:
- Inability to perform physical activity as determined by the PAR-Q
- Inability to adhere to protocol guidelines (e.g., alcohol, habitual diet)
- Regular tobacco use
- Illicit drug use (e.g., growth hormone, testosterone, etc.)
- Diagnosed medical condition under the care of a physician (e.g. type 2 diabetes)
- Inability to abstain from supplements (e.g. protein, creatine, HMB, BCAA, phosphatidic acid, etc.) at least three weeks before the trial
- Individuals on any medications known to affect protein metabolism (e.g., corticosteroids, non-steroidal anti-inflammatories, or prescription-strength acne medications)
- Participants that are amenorrheic (females only)
- On medications that may interfere with protein metabolism (e.g. anti-inflammatory drugs, hormone therapy)
- Regular tobacco use (e.g. daily use of oral or inhaled tobacco)
- Illicit drug use (e.g. growth hormone, testosterone, etc.)
- Inability to comply with the study protocol as judged by the investigators
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Di-Leucine supplement
Participants will consume a amino acid supplement containing Di-Leucine following resistance exercise and their whole body anabolism will be determined over the subsequent 6 hours |
Participants will consume a amino acid supplement containing Di-Leucine following resistance exercise and their whole body anabolism will be determined over the subsequent 6 hours |
|
Expérimental: BCAA Supplement
Participants will consume a amino acid supplement containing branched chain amino acids (BCAA) following resistance exercise and their whole body anabolism will be determined over the subsequent hours |
Participants will consume a amino acid supplement containing branched chain amino acids (BCAA) following resistance exercise and their whole body anabolism will be determined over the subsequent hours |
|
Expérimental: Collagen Supplement
Participants will consume a amino acid supplement containing collagen protein following resistance exercise and their whole body anabolism will be determined over the subsequent hours |
Participants will consume a amino acid supplement containing Collagen protein following resistance exercise and their whole body anabolism will be determined over the subsequent hours |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Whole-Body Protein Synthesis
Délai: 6 hours
|
Investigators will measure the enrichment of [13CO2] in the breath by isotope ratio mass spectrometry (IRMS) in atom percent excess (APE). The measurement of carbon dioxide production (VCO2) and stable isotope tracer enrichment in the breath allows for the assessment of the rate at which amino acids are used for energy (i.e., oxidized), rather than for protein synthesis (i.e., retained in the body) by calculating the fraction of expired CO2 that contains 13C. Leucine retention (umol/kg) will then be calculated from the difference between the known amount of leucine provided (ingested) and leucine oxidation (as determined from 13CO2 breath enrichment). |
6 hours
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Urinary Measures (Muscle Protein Breakdown)
Délai: 6 hours
|
Investigators will measure urinary 3-methylhistidine (3MH) as an indirect marker of muscle protein breakdown over the course of the trial (6 hours) through pooled urine collection vs baseline urine. |
6 hours
|
|
Murine Cell-Based Experiments (ex-vivo experiments) -hypertrophy
Délai: 60 minutes
|
Investigators will use human serum obtained from fasted and fed timepoints (15, 30, 45 and 60 minutes following beverage consumption) to condition cell culture media (20% volume). To determine the effects of using fasted and/or fed 'human-conditioned' culture media on cell growth, myotube diameter (hypertrophy) will be measured via microscopy following short term (4 hours) and long-term (24 hour) incubation in the human conditioned culture media. |
60 minutes
|
|
Murine Cell-Based Experiments (ex-vivo experiments) - Protein Synthesis
Délai: 60 minutes
|
Investigators will use human serum obtained from fasted and fed timepoints (15, 30, 45 and 60 minutes following beverage consumption) to condition cell culture media (20% volume). To determine the effects of using fasted and/or fed 'human-conditioned' culture media on cell protein synthesis, puromycin incorporation (measure of protein synthesis) will be measured via western blot. |
60 minutes
|
|
Murine Cell-Based Experiments (ex-vivo experiments) - mTORC1 Signalling
Délai: 60 minutes
|
Investigators will use human serum obtained from fasted and fed timepoints (15, 30, 45 and 60 minutes following beverage consumption) to condition cell culture media (20% volume). To determine the effects of using fasted and/or fed 'human-conditioned' culture media on cell anabolic signalling mTORC1 signalling will be measured via western blot. |
60 minutes
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- DiEx
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .