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Not yet recruitingNCT06744491NFRFUpdated Dec 20, 2024

Oral 'Breath Test' to Measure Anabolic Sensitivity to a Protein Meal Across the Age and Physical Activity Spectrum

An observational study in Inactivity, Physical, Aging and Healthy Aging, sponsored by University of Toronto. Not yet recruiting at 1 site in Canada. Open to participants aged 8 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-20.

Sponsored by University of Toronto · Observational

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 4 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
80
Ages
8 Years to 80 Years
Sex
All
01

Study summary

The purpose of this study is to determine how anabolic sensitivity, in response to the ingestion of a liquid protein meal, differs across the lifespan, between biological sexes, and with varying physical activity levels.

Read the detailed description

Skeletal muscle is a dynamic tissue that responds to anabolic (i.e., growth) stimuli such as protein ingestion and exercise. Differences in age and physical activity levels will influence an individual's ability to respond to these anabolic stimuli; this concept is known as anabolic sensitivity. For instance, older and less physically active individuals will display lower anabolic sensitivity (i.e., anabolic resistance) to a bout of exercise or the consumption of protein in comparison to younger, more physically active individuals. Seeing that individuals with anabolic resistance are at a greater risk for losing muscle mass over time, it is important to understand the anabolic sensitivity/resistance of an individual to assess for the efficiency of growth across the health and lifespan, in addition to a potential screen for metabolic alterations that could manifest into changes in lean body and muscle mass.

Traditional methods to assess for skeletal muscle anabolism and protein metabolism requires in-person and invasive research methods (i.e., stable isotope infusions and muscle biopsies) in controlled laboratory or clinical settings. However, there are many risks associated with these invasive procedures and they are not always feasible in all populations (e.g., children, clinical populations, etc..). Our lab has recently developed a non-invasive 13C breath test which employs an oral stable isotope tracer. Our breath test allows us to assess for anabolic sensitivity in response to protein ingestion, by determining how much of the ingested protein was used to build (synthesize) new proteins in our body (i.e., anabolism) or used as a source of energy (through a process called oxidation). As such, the purpose of the present study is to determine how anabolic sensitivity, in response to the ingestion of a liquid protein meal, differs across the lifespan and with varying physical activity levels.

02

Conditions studied

  • Inactivity, Physical
  • Aging
  • Healthy Aging
  • Growth & Development
  • Sex Differences
  • Anabolic Sensitivity
  • Protein Metabolism
  • Physical Activity

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Keywords

  • anabolic sensitivity
  • aging
  • growth and development
  • physical activity
  • skeletal muscle
  • stable isotopes
03

In context

Hypersensitivity

1,916 studies on the registry are indexed under Hypersensitivity; 265 are open to participants now.

This study's planned enrollment of 80 is below the median of 115 across 479 observational studies indexed under Hypersensitivity.

Browse Hypersensitivity studies →

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
8 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Convenience sample of individuals who qualify for the corresponding cohorts based on inclusion/exclusion criteria stated.

Inclusion criteria

  • Healthy will be defined as screened by the PAR-Q+ (The Physical Activity Readiness Questionnaire for everyone)
  • Chronological age for Healthy Young (age: 18-35 years) or Older (age: 60-80 years) adults
  • Chronological age between 8 to 16 years, with maturity offset \< -1 year from age of Peak Height Velocity (aPHV) for children and between -0.5 to +1.5 years from aPHV in adolescent participants
  • BMI between normal to overweight (18.5 - 29.9 kg/m2)

Exclusion criteria

Exclusion Criteria:

  • Regular use of nonsteroidal anti-inflammatory dugs (with the exception of daily low-dose aspirin)
  • use of anticoagulants
  • use of a walker, cane, or assistive walking device
  • infectious or gastrointestinal disease
  • inability to comply with study protocol (e.g., unable to track diet)
  • regular tobacco use
  • self-reported illicit drug use (e.g., growth hormone, testosterone, etc.)
  • diagnosed chronic illness (e.g., type 2 diabetes, heart disease, thyroid disease)
  • pregnant
  • hormonal replacement therapy
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
80 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Children

    Children as defined by maturity offset via age from peak height velocity (aPHV \< -1.0 years).

  • Adolescent

    Adolescents as defined by maturity offset via age from peak height velocity (aPHV -0.5 to +1.5 years)

  • Young Adults

    Young adults as defined by chronological age between ages 18 - 35 years

  • Older Adults

    Older adults as defined by chronological age between ages 60 - 80 years

06

What researchers measure

Primary outcomes

  1. Amino acid oxidation and net protein balance

    Amino acid oxidation and net protein balance assessed by oral 1-13C Leucine tracer. Net protein balance is derived from the difference between amino acid intake (known) and total amino acid oxidation over the 6h post-prandial measurement period.

    Time frame: 6 Hours

07

Study locations

1 site
  • Goldring Center for High Performance Sport
    Toronto, Ontario M5S 2C9, Canada
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06744491
Lead sponsor
University of Toronto
Responsible party
Daniel Moore (Professor, Muscle Physiology, University of Toronto) — Principal investigator
First posted
Dec 20, 2024
Start date
Dec 20, 2024 (estimated)
Primary completion
May 30, 2025 (estimated)
Completion
Aug 31, 2025 (estimated)
Last update
Dec 20, 2024

Study contacts

Daniel R Moore, PhD
Contact
dr.moore@utoronto.ca
4169464088
Hugo JW Fung, PhD Candidate
Contact
hugojernwai.fung@utoronto.ca

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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