CClinicalTrials.gg
CompletedNCT04887727Updated May 14, 2021

Development of Oral Amino Acid Tracers to Study Protein Turnover in Humans

An interventional study of Crystalline amino acids to assess myofibrillar protein synthesis rates and Crystalline amino acids to assess whole-body protein turnover, amino acid oxidation, and net protein balance in Healthy Adult Males, sponsored by University of Toronto. Completed at 1 site in Canada. Open to male participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-14.

Sponsored by University of Toronto · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 2 months after the study started (first participant enrolled Feb 2019, registered May 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
Male
01

Study summary

Previous studies have used a combination of oral L-[1-13C]leucine and intravenous labeled L-[5,5,5-2H3]leucine to assess the acute postprandial changes in whole-body protein turnover (12, 19). Intravenous and dietary-labeled amino acid tracers have also been used in tandem to assess rates of myofibrillar protein synthesis in response to bolus protein ingestion and resistance exercise (46). By validating whole-body net balance to myofibrillar protein synthesis, our proposed multi-tracer approach will develop minimally invasive models to study protein turnover in a variety of populations in which traditional infusions and/or repeated blood samples are not possible (i.e. pediatric, free-living populations).

Read the detailed description

The primary objective of the proposed study is to validate the use of a novel oral tracer model to accurately and reliably measure myofibrillar protein synthesis. It is hypothesized that oral L-[1-13C]leucine and L-[ring-2H5]phenylalanine, ingested as a bolus to mimic an intravenous 'pulse dose' administration (51, 65), will reveal similar rates of myofibrillar protein synthesis when compared to traditional intravenous L-[5,5,5-2H3]leucine infusion. Moreover, it is hypothesized that both methods will reveal the expected graded changes in myofibrillar protein synthesis in response to feeding and resistance exercise (i.e. fasted\<feeding\<exercise \& feeding).

The secondary objective of the proposed study is to develop and validate non-invasive models to measure whole-body amino acid oxidation and net balance in response to feeding and resistance exercise. It is hypothesized that whole-body net balance, as determined by a novel oral tracer model (i.e. L-[1-13C]leucine) , will align with traditional intravenous tracer methodology (i.e. L-[5,5,5-2H3]leucine) and reveal the expected physiological changes in whole-body protein turnover in response to feeding and resistance exercise (i.e. fasted\<feeding\<exercise \& feeding).

02

Conditions studied

  • Healthy Adult Males
03

In context

Lead sponsor

University of Toronto is the lead sponsor of 397 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Male
  • Currently performing structured physical activity 2-5 days per week

Exclusion criteria

Exclusion Criteria:

  • Unable to safely perform exercise as per PARQ+ guidelines
  • Currently using tobacco products
  • Currently using or have history of anabolic steroid use
  • Diagnosed with medical condition including type 2 diabetes, cancer, heart disease
  • Unable to abstain from supplement use (HMB, branched chain amino acids, phosphatidic acid) for at least three weeks prior to trial
  • currently using medications known to affect protein metabolism e.g. corticosteroids, NSAID, prescription-strength acne medication
  • allergic to local anesthetics
  • female: Hormonal fluctuations associated with the menstrual cycle have been reported to alter protein metabolism during exercise and may influence indices of the post-exercise myofibrillar protein synthetic response. Accordingly, the study will include males to ensure a stable hormonal environment and to increase the homogeneity of the physiological response.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
22 participants (actual)

Study arms

  • Experimental
    Healthy, recreationally-active adult males - Muscle Trial

    Subjects receive 0.25g/kg crystalline amino acids modelled after egg protein, enriched with L-\[1-13C\]leucine and L-ring-\[2H5\]phenylalanine with a primed-constant infusion of L-\[555-2H3\]leucine to assess myofibrillar protein synthesis rates

    Dietary Supplement: Crystalline amino acids to assess myofibrillar protein synthesis rates

  • Experimental
    Healthy, recreationally-active adult males - Whole Body Trial

    Subjects receive 0.25g/kg crystalline amino acids modelled after egg protein, enriched with L-\[1-13C\]leucine with a primed-constant infusion of L-\[555-2H3\]leucine to whole-body protein turnover, amino acid oxidation, and net protein balance

    Dietary Supplement: Crystalline amino acids to assess whole-body protein turnover, amino acid oxidation, and net protein balance

Interventions

  • Dietary supplementCrystalline amino acids to assess myofibrillar protein synthesis rates

    Amino acid dose = 0.25g/kg bodyweight

  • Dietary supplementCrystalline amino acids to assess whole-body protein turnover, amino acid oxidation, and net protein balance

    Amino acid dose = 0.25g/kg bodyweight

06

What researchers measure

Primary outcomes

  1. Myofibrillar protein synthesis rates

    Myofibrillar protein synthesis rates assessed by oral and intravenous tracers during Fast, Fed, and Ex-Fed

    Time frame: 5 hours

Secondary outcomes

  1. Whole-body protein turnover

    Whole-body protein turnover assessed by oral and intravenous tracers during Fast, Fed, and Ex-Fed

    Time frame: 5 hours

  2. Amino acid oxidation and net protein balance

    Amino acid oxidation and net protein balance assessed by oral tracers during Fast, Fed, and Ex-Fed. Net protein balance is derived from the difference between amino acid intake (known) and total amino acid oxidation over the 5h measurement period.

    Time frame: 5 hours

  3. Muscle anabolic signalling

    Immunoblotting for mTORC1/key downstream targets of mTORC1

    Time frame: 2 and 5 hours

  4. Amino acid transporter expression

    Immunoblotting for amino acid transporters LAT1/SNAT2

    Time frame: 2 and 5 hours

07

Study locations

1 site
  • Goldring Centre for High Performance Sport at the University of Toronto
    Toronto, Ontario M5S2C9, Canada
08

References and documents

Publications

  • Mazzulla M, Hodson N, West DWD, Kumbhare DA, Moore DR. A non-invasive 13CO2 breath test detects differences in anabolic sensitivity with feeding and heavy resistance exercise in healthy young males: a randomized control trial. Appl Physiol Nutr Metab. 2022 Aug 1;47(8):860-870. doi: 10.1139/apnm-2021-0808. Epub 2022 May 24. PubMed 35609328 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 14, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04887727
Lead sponsor
University of Toronto
Responsible party
Daniel Moore (Associate Professor, University of Toronto) — Principal investigator
First posted
May 14, 2021
Start date
Feb 25, 2019
Primary completion
Aug 31, 2019
Completion
Aug 31, 2019
Last update
May 14, 2021

Study contacts

Daniel R Moore, PhD
principal investigator · University of Toronto

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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