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

U

University of Toronto

Status

Not yet enrolling

Conditions

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

Study type

Observational

Funder types

Other

Identifiers

NCT06744491
00044004

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

8 to 80 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

80 participants in 4 patient groups

Children
Description:
Children as defined by maturity offset via age from peak height velocity (aPHV \< -1.0 years).
Adolescent
Description:
Adolescents as defined by maturity offset via age from peak height velocity (aPHV -0.5 to +1.5 years)
Young Adults
Description:
Young adults as defined by chronological age between ages 18 - 35 years
Older Adults
Description:
Older adults as defined by chronological age between ages 60 - 80 years

Trial contacts and locations

1

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Central trial contact

Daniel R Moore, PhD; Hugo JW Fung, PhD Candidate

Data sourced from clinicaltrials.gov

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