NCT02874638

Brief Summary

Protein requirements in individuals who participate in endurance-based exercise training have been suggested to be greater than the current recommended dietary allowance (RDA). The biological value of protein depends on its amino acid composition. Essential amino acids are believed to have main role on whole body protein metabolism. However, it remains to be determined what role non-essential amino acids (NEAA) may have in regulating protein metabolism and contributing to the increased protein requirements after endurance exercise. The indicator amino acid oxidation (IAAO) method has clarified the individual amino acid requirement in children, normal healthy adult and clinical populations. However, the IAAO method has never been utilized for assessing the effect of NEAA on protein requirements after endurance exercise. The objective of the current study is to investigate the importance of NEAA for endurance-trained male subjects.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 22, 2016

Completed
10 days until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

April 1, 2019

Status Verified

March 1, 2019

Enrollment Period

11 months

First QC Date

August 17, 2016

Last Update Submit

March 28, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 13CO2 (carbon dioxide) excretion rate (μmol/kg/h)

    8 hours after exercise followed by ingesting 13C-labelled phenylalanine and one of 5 different amount of amino acids intake, 13CO2 excretion rate is determined by multiplying the enrichment of 13CO2 in breath measured by Mass spectrometry and CO2 production rate measured by metabolic cart.

    at 8 hours after the end of exercise]

Secondary Outcomes (1)

  • [13C]phenylalanine oxidation rate (μmol/kg/h)

    at 8 hours after the end of exercise

Study Arms (4)

BASE egg protein

EXPERIMENTAL

0.8 g/kg/d of BASE protein provided as crystalline amino acid made after egg protein.

Dietary Supplement: BASE egg protein

BCAA-enriched egg protein

EXPERIMENTAL

branched-chain amino acid-enriched egg protein

Dietary Supplement: BCAA-enriched egg protein

small amount of essential amino acids

EXPERIMENTAL

small amount of essential amino acids made after egg protein, which is equivalent to the amount of essential amino acids in BASE

Dietary Supplement: small amount of essential amino acids

large amount of essential amino acids

EXPERIMENTAL

large amount of essential amino acids made after egg protein, which is equivalent to the amount of amino acids in BCAA

Dietary Supplement: large amount of essential amino acids

Interventions

BASE egg proteinDIETARY_SUPPLEMENT

0.8 g/kg/d of protein provided as crystalline amino acid modeled after egg protein

BASE egg protein
BCAA-enriched egg proteinDIETARY_SUPPLEMENT

BCAA-enriched egg protein provided as crystalline amino acid.

BCAA-enriched egg protein

essential amino acids modeled after egg protein, provided as crystalline amino acid, which is equivalent to the amount of essential amino acid in BASE egg protein

small amount of essential amino acids

essential amino acids modeled after egg protein, provided as crystalline amino acid, which is equivalent to the amount of amino acid in BCAA-enriched egg protein

large amount of essential amino acids

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • endurance-trained participants who regularly run more than 40 km/week
  • Participants who are categorized at least "very good" based on a study by Shvartz \& Reibold, in which VO2peak is used as an index. (i.e. the participants whose VO2peak is ≥57 ml/kg/min (18-24 y), ≥54 ml/kg/min (25-29 y), ≥52 ml/kg/min (30-34 y), ≥49 ml/kg/min (35-39 y)
  • Ability to complete the 16-km familiarization run in session 2

You may not qualify if:

  • Inability to meet health and physical activity guidelines according to the physical activity readiness questionnaire (PAR-Q+)
  • Inability to adhere to any of the protocol guidelines (i.e. alcohol, caffeine consumption)
  • Regular tobacco use
  • Illicit drug use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Daniel Moore, Ph.D.

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 17, 2016

First Posted

August 22, 2016

Study Start

September 1, 2016

Primary Completion

August 1, 2017

Study Completion

December 31, 2017

Last Updated

April 1, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share