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

NCT05216809 | Unknown

• 1 other identifier: ARBT
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  6 hours

• 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.

  6 hours

Study Arms (2)

Young Adults

ACTIVE COMPARATOR

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

Behavioral: Habitual Physical Activity; Behavioral: Step-Reduction

Older Adults

ACTIVE COMPARATOR

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

Behavioral: Habitual Physical Activity; Behavioral: Step-Reduction

Interventions

Habitual Physical Activity BEHAVIORAL

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

Older Adults; Young Adults

Step-Reduction BEHAVIORAL

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

Older Adults; Young Adults

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Toronto: lead

Study Sites (1)

Goldring Centre for High Performance Sport at the University of Toronto

Toronto, Ontario, M5S2C9, Canada

RECRUITING

MeSH Terms

Conditions

Sedentary Behavior; Sarcopenia; Motor Activity

Condition Hierarchy (Ancestors)

Behavior; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Daniel Moore, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

• Hugo JW Fung, PhD (c)

  University of Toronto

  STUDY DIRECTOR

Central Study Contacts

Daniel R Moore, PhD

CONTACT

4169464088; dr.moore@utoronto.ca

Matthew Lees, PhD

CONTACT

matthew.lees@utoronto.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Parallel Group Cohort Study Twenty healthy young (18-35 years of age; 10 females and 10 males) and twelve healthy older adults (60-80 years of age; 6 females and 6 males), for a total of 32 individuals, will undergo 3 days (Days 1-3) of Habitual Activity in a free-living setting (Phase 1) followed by a metabolic trial (Day 4), where individuals will be subjected to a non-invasive 13CO2 breath-test. This will also serve as a lead-in period for the subsequent 3 days of step-reduction (\<2,000 steps/day; Days 4-6). Following the 3-days of reduced daily step count (Day 7), participants will undergo another metabolic trial day involving the non-invasive 13CO2 breath-test in order for us to determine changes in anabolic sensitivity.

Study Record Dates

• First Submitted: November 7, 2021
• First Posted: February 1, 2022
• Study Start: February 1, 2022
• Primary Completion: January 1, 2024
• Study Completion: March 1, 2024
• Last Updated: November 9, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)