Development of Oral Amino Acid Tracers to Study Protein Turnover in Humans
1 other identifier
interventional
22
1 country
1
Brief Summary
Previous studies have used a combination of oral L-\[1-13C\]leucine and intravenous labeled L-\[5,5,5-2H3\]leucine to assess the acute postprandial changes in whole-body protein turnover (12, 19). Intravenous and dietary-labeled amino acid tracers have also been used in tandem to assess rates of myofibrillar protein synthesis in response to bolus protein ingestion and resistance exercise (46). By validating whole-body net balance to myofibrillar protein synthesis, our proposed multi-tracer approach will develop minimally invasive models to study protein turnover in a variety of populations in which traditional infusions and/or repeated blood samples are not possible (i.e. pediatric, free-living populations).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2019
CompletedFirst Submitted
Initial submission to the registry
May 5, 2021
CompletedFirst Posted
Study publicly available on registry
May 14, 2021
CompletedMay 14, 2021
May 1, 2021
6 months
May 5, 2021
May 10, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Myofibrillar protein synthesis rates
Myofibrillar protein synthesis rates assessed by oral and intravenous tracers during Fast, Fed, and Ex-Fed
5 hours
Secondary Outcomes (4)
Whole-body protein turnover
5 hours
Amino acid oxidation and net protein balance
5 hours
Muscle anabolic signalling
2 and 5 hours
Amino acid transporter expression
2 and 5 hours
Study Arms (2)
Healthy, recreationally-active adult males - Muscle Trial
EXPERIMENTALSubjects receive 0.25g/kg crystalline amino acids modelled after egg protein, enriched with L-\[1-13C\]leucine and L-ring-\[2H5\]phenylalanine with a primed-constant infusion of L-\[555-2H3\]leucine to assess myofibrillar protein synthesis rates
Healthy, recreationally-active adult males - Whole Body Trial
EXPERIMENTALSubjects receive 0.25g/kg crystalline amino acids modelled after egg protein, enriched with L-\[1-13C\]leucine with a primed-constant infusion of L-\[555-2H3\]leucine to whole-body protein turnover, amino acid oxidation, and net protein balance
Interventions
Amino acid dose = 0.25g/kg bodyweight
Amino acid dose = 0.25g/kg bodyweight
Eligibility Criteria
You may qualify if:
- Male
- Currently performing structured physical activity 2-5 days per week
You may not qualify if:
- Unable to safely perform exercise as per PARQ+ guidelines
- Currently using tobacco products
- Currently using or have history of anabolic steroid use
- Diagnosed with medical condition including type 2 diabetes, cancer, heart disease
- Unable to abstain from supplement use (HMB, branched chain amino acids, phosphatidic acid) for at least three weeks prior to trial
- currently using medications known to affect protein metabolism e.g. corticosteroids, NSAID, prescription-strength acne medication
- allergic to local anesthetics
- female: Hormonal fluctuations associated with the menstrual cycle have been reported to alter protein metabolism during exercise and may influence indices of the post-exercise myofibrillar protein synthetic response. Accordingly, the study will include males to ensure a stable hormonal environment and to increase the homogeneity of the physiological response.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Goldring Centre for High Performance Sport at the University of Toronto
Toronto, Ontario, M5S2C9, Canada
Related Publications (1)
Mazzulla M, Hodson N, West DWD, Kumbhare DA, Moore DR. A non-invasive 13CO2 breath test detects differences in anabolic sensitivity with feeding and heavy resistance exercise in healthy young males: a randomized control trial. Appl Physiol Nutr Metab. 2022 Aug 1;47(8):860-870. doi: 10.1139/apnm-2021-0808. Epub 2022 May 24.
PMID: 35609328DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel R Moore, PhD
University of Toronto
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
May 5, 2021
First Posted
May 14, 2021
Study Start
February 25, 2019
Primary Completion
August 31, 2019
Study Completion
August 31, 2019
Last Updated
May 14, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share