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

December 16, 2024 updated by: Daniel Moore, University of Toronto

Anabolic Sensitivity Across the Lifespan

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.

Study Overview

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.

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Ontario
      • Toronto, Ontario, Canada, M5S 2C9
        • Goldring Center for High Performance Sport
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

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.

Description

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amino acid oxidation and net protein balance
Time Frame: 6 Hours
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.
6 Hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 20, 2024

Primary Completion (Estimated)

May 30, 2025

Study Completion (Estimated)

August 31, 2025

Study Registration Dates

First Submitted

December 16, 2024

First Submitted That Met QC Criteria

December 16, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 16, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Physical Activity

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