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

November 8, 2023 updated by: Daniel Moore, University of Toronto

The Efficacy of a Non-Invasive 13CO2 'Breath Test' to Detect Anabolic Resistance Following Step Reduction in Younger and Older Adults

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Not Applicable

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

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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:

  • 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

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

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Young Adults
Equal sex distribution (10M/10F); ages 18-35 years old.
Behavioral: Habitual 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.
Other Names:
  • Free-Living Activity
Behavioral: Step-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.
Other Names:
  • Reduced Physical Activity
Active Comparator: Older Adults
Equal sex distribution (6M/6F); ages 60-80 years old.
Behavioral: Habitual 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.
Other Names:
  • Free-Living Activity
Behavioral: Step-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.
Other Names:
  • Reduced Physical Activity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exogenous Leucine Oxidation (umol/kg)
Time Frame: 6 hours
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)
Time Frame: 6 hours
Whole-Body Net Leucine Retention determined from the difference between exogenous leucine oxidation and leucine ingestion the 6 hour measurement period.
6 hours

Collaborators and Investigators

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

Sponsor

University of Toronto

Investigators

  • Principal Investigator: Daniel Moore, PhD, University of Toronto
  • Study Director: Hugo JW Fung, PhD (c), University of Toronto

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 (Actual)

February 1, 2022

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

March 1, 2024

Study Registration Dates

First Submitted

November 7, 2021

First Submitted That Met QC Criteria

January 18, 2022

First Posted (Actual)

February 1, 2022

Study Record Updates

Last Update Posted (Estimated)

November 9, 2023

Last Update Submitted That Met QC Criteria

November 8, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARBT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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