Modified Breath Test to Determine Anabolic Sensitivity Across Physical Activity States

NCT06209424 | Unknown

• 1 other identifier: 00044918
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Developing tools to detect when our bodies are more resistant towards protein synthesis is valuable for identification of when someone may be at risk of losing body or muscle mass such as with aging or certain diseases. The current study aims to refine our previous breath test method to be more effective at measuring changes in how the body processes protein in different situations, such as resting, reducing physical activity, and doing resistance exercise. We hypothesize that using a lower amount of dietary amino acids in our breath test will be effective at detecting lower amounts of amino acids used after exercise, and a greater amount with step reduction compared to normal activity levels

Conditions

Resistance Exercise; Physical Inactivity; Amino Acids; Dietary Protein

Keywords

Sex; Step-Reduction; Habitual Activity; Protein Metabolism; Resistance Exercise; Stable Isotopes; Anabolic Sensitivity

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.

  5 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.

  5 hours

Other Outcomes (1)

• Feeling and Felt Arousal (Likert Scale)

  6 days (during at-home phase)

Study Arms (2)

In-Person Phase

ACTIVE COMPARATOR

Habitual Activity + Resistance Exercise Metabolic Trials

Behavioral: Habitual Activity; Behavioral: Resistance Exercise

At-Home Phase

ACTIVE COMPARATOR

Habitual Activity + Step-Reduction Metabolic Trials

Behavioral: Habitual Activity; Behavioral: Step-Reduction

Interventions

Habitual Activity BEHAVIORAL

Participants will maintain habitual levels of physical activity (inclusive of structured physical activity).

Also known as: Free-Living Activity

At-Home Phase; In-Person Phase

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

At-Home Phase

Resistance Exercise BEHAVIORAL

Participants will undergo a 50-minute resistance exercise protocol, which includes multiple sets of different exercises using weights. Each set will consist of 10 repetitions at 75% of their 1 repetition maximum (1RM). The exercises include bench press superset with lat pulldowns, overhead press superset with seated cable rows, leg press, and leg extensions with 90s rest in between sets. Before the exercise protocol, there will be a standardized 10-minute warm-up that involves cycling, leg swings, arm circles, bodyweight squats, and bench push-ups

Also known as: Full-Body Resistance Exercise

In-Person Phase

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy young (age: 18-35 years)
• BMI between normal to overweight (18.5-29.9 kg/m2)
• if oral contraceptive (OC) user, must be on monophasic OCs for at least 3 months prior to study
• if non-OC user, then must have regular menstrual cycles (length: 25-35 days) for at least 3 months prior to study and at least 6 months off of OCs

You may not qualify if:

• Chronic disease diagnosis (cardiovascular, thyroid, diabetes)
• Current or recent remission of cancer
• Regular use of NSAID (except low-dose aspirin), anticoagulants
• Use of prescription drugs that would impact muscle protein synthesis (e.g., Statins, Lithium, ADHD medication, etc..)
• Insertion of intrauterine device (IUD) - exception: copper
• Smoking
• Use of illicit drugs (growth hormones, testosterone)

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; Coitus

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Behavior; Sexual Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ines Kortebi, MSc

  University of Toronto

  STUDY DIRECTOR

• Hugo JW Fung, PhD (c)

  University of Toronto

  STUDY CHAIR

• Daniel R Moore, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel R Moore, PhD

CONTACT

4169464088; dr.moore@utoronto.ca

Hugo JW Fung, PhD (c)

CONTACT

6472098764; hugojernwai.fung@utoronto.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants will be randomized to either begin their participation with the "at-home" or "in-person" phase of the study. There is no need to conceal the randomization as this study is not blinded - this does not affect our outcome as we are looking at physiological changes with feeding.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized Counter-Balanced Crossover Design Following familiarization, participants will be split into an in-person phase, consisting of a habitual rest and subsequent whole-body resistance exercise metabolic trials, and an at-home phase, which includes a habitual rest followed by a step-reduction metabolic trial. Participants will be randomized through a counterbalanced approach to either start with the in-person or at-home phases of our study as outlined below. Participants will be grouped by sex to ensure the same number of individuals from both males and females will undergo the in-person or at-home phases first

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: January 17, 2024
• Study Start: January 15, 2024
• Primary Completion: December 31, 2024
• Study Completion: April 30, 2025
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)