CClinicalTrials.gg
RecruitingNCT05216809ARBTUpdated Nov 9, 2023

Oral 'Breath Test' to Measure Anabolic Sensitivity in Young and Older Adults at Different Activity Levels

An interventional study of Habitual Physical Activity and Step-Reduction in Sedentary Behavior, Aging and Sarcopenia, sponsored by University of Toronto. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-09.

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

From the registry’s dates

  • Primary completion was expected by Jan 2024, 2 years 9 months ago, but the record still lists the study as recruiting.
  • Started Feb 2022; still recruiting 4 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

Recent work in the investigators laboratory has examined the ability of a non-invasive 13CO2 breath-test to assess differences in amino acid oxidation rates and net balance in young healthy males following protein feeding and resistance exercise. The investigators aim to test the efficacy of this non-invasive 13CO2 breath-test to assess for differences in anabolic sensitivity between young and older adults following an acute period of habitual and reduced physical activity.

Read the detailed description

Aging is associated with a phenomenon known as anabolic resistance, whereby individuals are less responsive to anabolic stimuli (i.e., resistance exercise, dietary protein ingestion). Mild and severe reductions in physical activity are also known to play a key role in the emergence of anabolic resistance. Therefore, the purpose of this study is to investigate the ability of a non-invasive 13CO2 breath-test to assess differences in whole-body leucine oxidation and leucine net balance between younger and older individuals under conditions of habitual activity and following a period of reduced activity/step-reduction. In this manner, the ability of the methodology to distinguish anabolic sensitivity between young and older adult populations will be assessed.

Methods:

Total participant time commitment will span over 4 sessional dates:

Session 1 - Introduction Interested participants will be recruited to engage in a video conference call to undergo an introductory session. Participants will be provided with a comprehensive introduction to the study which will explain the research objectives, conduct, and associated risks. Participants will provide informed consent prior to the collection of any study information (i.e., anthropometrics and habitual activity levels). Eligibility will also be screened for at this time.

Session 2 - Body Composition Assessment Participants will consume a bolus of deuterium oxide (D2O) and provide saliva samples in order to estimate fat-free mass.

The remainder of the study will consist of seven consecutive days, wherein Phase 1 (Habitual Activity) will be subsequently followed by Phase 2 (Step-Reduction).

Phase 1 - Habitual Activity (Days 1-3) Participants will be asked to engage in their habitual activity pattern (> 7000 steps/day) while wearing an accelerometer and pedometer. Participants will be further instructed to maintain their normal dietary patterns and to track their diets over the course of these three days using diet logs.

Session 3 - Habitual Activity Metabolic Trial (Day 4) On the morning of the fourth day, following three days of habitual activity, participants will be subjected to the non-invasive 13CO2 breath-test to assess for whole-body leucine oxidation and net balance. This date will also serve as a lead-in to the subsequent Phase 2.

Phase 2 - Step-Reduction (Days 4-6) Participants will be asked to maintain their normal dietary patterns and track their dietary intake, but will need to adhere to a reduced daily step count (\<2000 steps/day). Accelerometers and pedometers will be worn again during this period.

Session 4 - Step-Reduction Metabolic Trial (Day 7) On the morning of the 7th day, following three days of reduced daily step-count, participants will be subjected again to the non-invasive 13CO2 breath-test to assess for whole-body leucine oxidation and net balance. Ultimately, this will allow us to determine whether 3-days of reduced step-count will impart any changes on anabolic sensitivity.

For each metabolic trial, two urine samples (baseline and pooled enriched) will be collected, in addition to breath samples collected over a 6-hour post-prandial period at 20-30 minute intervals. These biological samples will be used to measure tracer excretion and oxidation, allowing us to determine rates of protein metabolism.

02

Conditions studied

  • Sedentary Behavior
  • Aging
  • Sarcopenia
  • Amino Acids
  • Dietary Protein

Browse trials for

Keywords

  • Skeletal Muscle
  • Step-Reduction
  • Aging
  • Anabolic Resistance
  • Physical Activity
  • Stable Isotopes
03

In context

Sarcopenia

1,208 studies on the registry are indexed under Sarcopenia; 401 are open to participants now.

This study's planned enrollment of 32 is below the median of 60 across 773 interventional studies indexed under Sarcopenia.

Browse Sarcopenia 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
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy young (age: 18-35 years) or older (age: 60-80 years) adults
  • Average daily step-count >7,000/day
  • BMI between normal to overweight (18.5-29.9 kg/m2)

Exclusion criteria

Exclusion Criteria:

  • Regular use of nonsteroidal anti-inflammatory drugs (with the exception of daily low-dose aspirin)
  • Use of anticoagulants
  • Use of a walker, cane, or assistive walking device
  • Current or recently remised cancer
  • Infectious or gastrointestinal disease
  • Inability to comply with study protocol (e.g., >2,000 steps/day during Step-Reduction Phase)
  • 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

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
32 participants (estimated)

Study arms

  • Active comparator
    Young Adults

    Equal sex distribution (10M/10F); ages 18-35 years old.

    Behavioral: Habitual Physical Activity · Behavioral: Step-Reduction

  • Active comparator
    Older Adults

    Equal sex distribution (6M/6F); ages 60-80 years old.

    Behavioral: Habitual Physical Activity · Behavioral: Step-Reduction

Interventions

  • BehavioralHabitual Physical Activity

    Participants will maintain habitual levels of physical activity (inclusive of structured physical activity). Participants will be required to maintain \>7,000 steps/day.

    Also known as: Free-Living Activity

  • BehavioralStep-Reduction

    Participants will be required to reduce their daily step-counts to \<2,000 steps/day. Further, they will be required to refrain from structured physical activity.

    Also known as: Reduced Physical Activity

06

What researchers measure

Primary outcomes

  1. Exogenous Leucine Oxidation (umol/kg)

    Exogenous Leucine Oxidation determined from breath 13CCO2 enrichment. Breath samples will be collected every 20-30min after test drink ingestion to determine breath 13CO2 enrichment. Total leucine oxidation will be determined from the area under the 13CO2 enrichment by time curve.

    Time frame: 6 hours

  2. Net Leucine Retention (umol/kg)

    Whole-Body Net Leucine Retention determined from the difference between exogenous leucine oxidation and leucine ingestion the 6 hour measurement period.

    Time frame: 6 hours

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

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 Nov 9, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05216809
Lead sponsor
University of Toronto
Responsible party
Daniel Moore (Principal Investigator, University of Toronto) — Principal investigator
First posted
Feb 1, 2022
Start date
Feb 1, 2022
Primary completion
Jan 1, 2024 (estimated)
Completion
Mar 2024 (estimated)
Last update
Nov 9, 2023

Study contacts

Daniel R Moore, PhD
Contact
dr.moore@utoronto.ca
4169464088
Matthew Lees, PhD
Contact
matthew.lees@utoronto.ca
Daniel Moore, PhD
principal investigator · University of Toronto
Hugo JW Fung, PhD (c)
study director · University of Toronto

Oversight

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

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion