NCT02628249

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 the amino acid composition. As liebig's law of the minimum, the protein synthesis is limited due to the lack of single rate limiting amino acid. In this case, the first rate limiting amino acid determines protein intakes to maximize the protein synthesis. Adding a small amount of rate-limiting amino acid to the diet improves the biological value of its protein diet. 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 determining the first rate limiting amino acid. Therefore, the purpose of this study is to address of IAAO method to be applied for determining the rate-limiting amino acid in endurance athlete.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 11, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
6 months 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

1.8 years

First QC Date

December 7, 2015

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 (5)

Base protein

EXPERIMENTAL

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

Dietary Supplement: Base protein

Sufficient protein

EXPERIMENTAL

1.75 g/kg/d protein provided as crystalline amino acid made after egg protein.

Dietary Supplement: Sufficient protein

Base + BCAA

EXPERIMENTAL

Base protein intake + Branched chain amino acids

Dietary Supplement: Base proteinDietary Supplement: Branched chain amino acids

Base + EAA

EXPERIMENTAL

Base protein intake + essential amino acids.

Dietary Supplement: Base proteinDietary Supplement: Essential amino acids

Base + NEAA

EXPERIMENTAL

Base protein intake + non essential amino acids

Dietary Supplement: Base proteinDietary Supplement: Non essential amino acids

Interventions

Base proteinDIETARY_SUPPLEMENT

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

Base + BCAABase + EAABase + NEAABase protein
Sufficient proteinDIETARY_SUPPLEMENT

1.75 g/kg/d protein provided as crystalline amino acid modeled after egg protein.

Sufficient protein
Branched chain amino acidsDIETARY_SUPPLEMENT

Branched chain amino acids modeled after egg protein.

Base + BCAA
Essential amino acidsDIETARY_SUPPLEMENT

Essential amino acids modeled after egg protein.

Base + EAA
Non essential amino acidsDIETARY_SUPPLEMENT

Non essential amino acids modeled after egg protein.

Base + NEAA

Eligibility Criteria

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

You may qualify if:

  • 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. Branched-Chain Amino Acids Are the Primary Limiting Amino Acids in the Diets of Endurance-Trained Men after a Bout of Prolonged Exercise. J Nutr. 2018 Jun 1;148(6):925-931. doi: 10.1093/jn/nxy048.

MeSH Terms

Interventions

Amino AcidsAmino Acids, Essential

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

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 professaor

Study Record Dates

First Submitted

December 7, 2015

First Posted

December 11, 2015

Study Start

September 1, 2015

Primary Completion

June 1, 2017

Study Completion

December 1, 2017

Last Updated

April 1, 2019

Record last verified: 2019-03