NCT02478814

Brief Summary

Protein requirements in active individuals have been suggested to be greater than the current recommended dietary allowance (RDA). Nutritional requirements for dietary amino acids in adults have traditionally been determined utilizing the nitrogen balance technique, which is prone to underestimating protein requirements. As a result, there is a need to re-evaluate recommendations in order to characterize how dietary amino acid needs may be modulated by physical activity. Recent studies using the minimally invasive indicator amino acid oxidation (IAAO) technique have suggested that protein requirements in young men are at least 50% higher than the RDA based on nitrogen balance data. The purpose of this study is to measure the protein requirement in active, young adult males using the IAAO technique in the presence of a variable intensity exercise stimulus.

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 Apr 2015

Typical duration for not_applicable

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

Study Start

First participant enrolled

April 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 23, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 1, 2019

Status Verified

March 1, 2019

Enrollment Period

1.2 years

First QC Date

June 18, 2015

Last Update Submit

March 28, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

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

    4 hours / study day

Secondary Outcomes (1)

  • 13C-Phenylalanine Oxidation (μmol/kg/h)

    4 hours / study day

Study Arms (1)

Active, Young Adult Males

EXPERIMENTAL

Subjects will receive different levels of amino acid intakes varying from 0.2 to 2.6 g/kg/day.

Dietary Supplement: Amino Acid Intake

Interventions

Amino Acid IntakeDIETARY_SUPPLEMENT

Amino acid intakes will be varied at 0.2-2.6 g/kg/day

Active, Young Adult Males

Eligibility Criteria

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

You may qualify if:

  • Healthy, active, young adult males who regularly participate in moderate-vigorous activity 5x per week, for a minimum of 1 hour
  • A minimum score of 10 on the Beep Test (a measure of aerobic fitness)

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

Related Publications (1)

  • Packer JE, Wooding DJ, Kato H, Courtney-Martin G, Pencharz PB, Moore DR. Variable-Intensity Simulated Team-Sport Exercise Increases Daily Protein Requirements in Active Males. Front Nutr. 2017 Dec 21;4:64. doi: 10.3389/fnut.2017.00064. eCollection 2017.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 18, 2015

First Posted

June 23, 2015

Study Start

April 1, 2015

Primary Completion

June 1, 2016

Study Completion

December 1, 2017

Last Updated

April 1, 2019

Record last verified: 2019-03