NCT02478801

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). 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 RDA based on nitrogen balance data. Therefore, the purpose of this study is to measure the protein requirement in endurance trained adults using the IAAO technique.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Mar 2015

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

March 1, 2015

Completed
4 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
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

June 16, 2016

Status Verified

June 1, 2016

Enrollment Period

10 months

First QC Date

June 18, 2015

Last Update Submit

June 15, 2016

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)

Endurance trained

EXPERIMENTAL

subjects will receive different levels of amino acids intakes varying from 0.2 to 2.8 g/kg/day.

Dietary Supplement: amino acids intake

Interventions

amino acids intakeDIETARY_SUPPLEMENT

amino acids intakes will be varied at 0.2-2.8 g/kg/day

Endurance trained

Eligibility Criteria

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

You may qualify if:

  • Healthy, male, endurance-trained participants who regularly more than 40 km/week
  • Ability to perform the exercise stimulus (20 km run) on metabolic trial.

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)

  • Kato H, Suzuki K, Bannai M, Moore DR. Protein Requirements Are Elevated in Endurance Athletes after Exercise as Determined by the Indicator Amino Acid Oxidation Method. PLoS One. 2016 Jun 20;11(6):e0157406. doi: 10.1371/journal.pone.0157406. eCollection 2016.

Study Design

Study Type
interventional
Phase
early phase 1
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

March 1, 2015

Primary Completion

January 1, 2016

Study Completion

May 1, 2016

Last Updated

June 16, 2016

Record last verified: 2016-06