- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05754125
In vivo og in vitro anabolske potentiale af essentielle aminosyrer efter modstandstræning (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).
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Ontario
-
Toronto, Ontario, Canada, M5S2C9
- Goldring Centre for High Performance Sport at the University of Toronto
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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 |
|
Eksperimentel: 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 |
|
Eksperimentel: 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 |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Whole-Body Protein Synthesis
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Urinary Measures (Muscle Protein Breakdown)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- DiEx
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .