NCT04887727

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 5, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 14, 2021

Completed
Last Updated

May 14, 2021

Status Verified

May 1, 2021

Enrollment Period

6 months

First QC Date

May 5, 2021

Last Update Submit

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

EXPERIMENTAL

Subjects 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

Dietary Supplement: Crystalline amino acids to assess myofibrillar protein synthesis rates

Healthy, recreationally-active adult males - Whole Body Trial

EXPERIMENTAL

Subjects 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

Dietary Supplement: Crystalline amino acids to assess whole-body protein turnover, amino acid oxidation, and net protein balance

Interventions

Amino acid dose = 0.25g/kg bodyweight

Healthy, recreationally-active adult males - Muscle Trial

Amino acid dose = 0.25g/kg bodyweight

Healthy, recreationally-active adult males - Whole Body Trial

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

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.

Study Officials

  • Daniel R Moore, PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Three groups: Fast, Fed, Ex-Fed Two trials per group
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

Locations