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

NCT ID: NCT06744491

Last Updated: 2024-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-20

Study Completion Date

2025-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Children

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

No interventions assigned to this group

Adolescent

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

No interventions assigned to this group

Young Adults

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

No interventions assigned to this group

Older Adults

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

8 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Toronto

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Daniel Moore

Professor, Muscle Physiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Goldring Center for High Performance Sport

Toronto, Ontario, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Daniel R Moore, PhD

Role: CONTACT

Phone: 4169464088

Email: [email protected]

Hugo JW Fung, PhD Candidate

Role: CONTACT

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Hugo JW Fung, PhD Candidate

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

00044004

Identifier Type: -

Identifier Source: org_study_id