NCT05754125

Brief Summary

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 21, 2023

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 31, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 3, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2024

Completed
Last Updated

November 9, 2023

Status Verified

November 1, 2023

Enrollment Period

6 months

First QC Date

January 31, 2023

Last Update Submit

November 8, 2023

Conditions

Keywords

Di-leucineBranched chain amino acidsCollagenAmino acidsanabolismcatabolism

Outcome Measures

Primary Outcomes (1)

  • Whole-Body Protein Synthesis

    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

Secondary Outcomes (4)

  • Urinary Measures (Muscle Protein Breakdown)

    6 hours

  • Murine Cell-Based Experiments (ex-vivo experiments) -hypertrophy

    60 minutes

  • Murine Cell-Based Experiments (ex-vivo experiments) - Protein Synthesis

    60 minutes

  • Murine Cell-Based Experiments (ex-vivo experiments) - mTORC1 Signalling

    60 minutes

Study Arms (3)

Di-Leucine supplement

EXPERIMENTAL

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

Dietary Supplement: Di-Leucine Supplement

BCAA Supplement

EXPERIMENTAL

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

Dietary Supplement: BCAA Supplement

Collagen Supplement

EXPERIMENTAL

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

Dietary Supplement: Collagen Supplement

Interventions

Di-Leucine SupplementDIETARY_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

Di-Leucine supplement
BCAA SupplementDIETARY_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

BCAA Supplement
Collagen SupplementDIETARY_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

Collagen Supplement

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Trained individuals currently performing structured exercise (e.g., running, weightlifting, team-sport activity) at least 2 days per week for the previous 3 months

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Goldring Centre for High Performance Sport at the University of Toronto

Toronto, Ontario, M5S2C9, Canada

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Neither participants, investigators, or data analysts will be aware of the supplement assignment (labelled A-C) until data analysis for the primary outcome is complete.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Cross over study design; Block randomized.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 31, 2023

First Posted

March 3, 2023

Study Start

January 21, 2023

Primary Completion

July 30, 2023

Study Completion

January 30, 2024

Last Updated

November 9, 2023

Record last verified: 2023-11

Locations