NCT02801344

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). Our recent study using the minimally invasive indicator amino acid oxidation (IAAO) technique have suggested that protein requirements in young men are at least 30% higher than the recommended protein intake. The present study will investigate the impact of protein sufficiency on protein metabolism and performance during intensified training periods as a means to further our understanding of the nutritional requirements for the endurance athlete.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started May 2016

Typical duration for not_applicable healthy

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

May 1, 2016

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

May 25, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 15, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

March 29, 2019

Status Verified

March 1, 2019

Enrollment Period

1.3 years

First QC Date

May 25, 2016

Last Update Submit

March 28, 2019

Conditions

Keywords

exerciseperformancerecoverymuscleprotein

Outcome Measures

Primary Outcomes (1)

  • Change in 24h whole body protein balance

    Protein balance (mg/kg/d; protein synthesis - protein breakdown) will be measured using \[15N\]Glycine method on day 1 and day 4 to determine the change over the intensified training period to compare between protein levels

    Difference between day 1 and day 4 whole body protein balance

Secondary Outcomes (3)

  • Change from baseline physical performance (5 km time trial) 5days after the beginning of training

    5days after the beginning of training

  • change from baseline Physical performance (muscle strength) 5days after the beginning of training

    5days after the beginning of training

  • change from baseline Physical Performance (muscle power) 5days after the beginning of training

    5days after the beginning of training

Other Outcomes (5)

  • Creatine Phosphate Kinase activity on day 5

    5days after the beginning of training

  • Myoglobin concentration on day 5

    5days after the beginning of training

  • IL-6 concentration on day 5

    5days after the beginning of training

  • +2 more other outcomes

Study Arms (3)

Normal protein intake

EXPERIMENTAL

participants will receive the controlled-diet containing 0.8 g protein /kg/day and the test drink containing 0.14 g protein/kg/d.

Dietary Supplement: NormalOther: Controlled-diet

Moderate protein intake

EXPERIMENTAL

participants will receive the controlled-diet containing 1.20 g protein /kg/day and the test drink containing 0.40 g protein/kg/d.

Dietary Supplement: ModerateOther: Controlled-diet

High protein intake

EXPERIMENTAL

participants will receive the controlled-diet containing 1.83 g protein /kg/day and the test drink containing 1.03 g protein/kg/d.

Dietary Supplement: HighOther: Controlled-diet

Interventions

NormalDIETARY_SUPPLEMENT

test drink which contains low amount of amino acids (0.14 g/kg/day)

Normal protein intake
ModerateDIETARY_SUPPLEMENT

test drink which contains moderate amount of amino acids (0.40 g/kg/day)

Moderate protein intake
HighDIETARY_SUPPLEMENT

test drink which contains high amount of amino acids (1.03 g/kg/day)

High protein intake

the diet containing 0.8 g protein /kg/day

High protein intakeModerate protein intakeNormal protein intake

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy, male, endurance-trained participants who have run regularly more than 45 km or 4.5 hours/week
  • Participants who are categorized at least "very good" based on a study by Shvartz \& Reibold \[40\], in which peak rate of oxygen consumption(VO2 Peak) 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), ≥47 ml/kg/min (40-44 y), ≥44 ml/kg/min (45-50 y) according to his age,
  • Participants who can cover 10 km in less than 60 min after the VO2peak test and 5 km Time trial on session 2.
  • Participants will be 18-50 years old.
  • Participants are willing to abide by the compliance rules of this study

You may not qualify if:

  • Inability to meet health and physical activity guidelines according to the The Physical Activity Readiness Questionnaire for everyone.
  • Female
  • Inability to adhere to any of the compliance rules judged by principal investigator or medical doctor
  • Regular tobacco use
  • Illicit drug use (e.g. growth hormone, testosterone, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Goldring Centre For High Performance Sport

Toronto, Ontario, M5S 2C9, Canada

Location

Related Publications (1)

  • Williamson E, Kato H, Volterman KA, Suzuki K, Moore DR. Greater plasma essential amino acids and lower 3-methylhistidine with higher protein intake during endurance training: a randomised control trial. Amino Acids. 2023 Oct;55(10):1285-1291. doi: 10.1007/s00726-022-03210-z. Epub 2022 Dec 7.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Daniel Moore, Ph.D.

    Faculty of Kinesiology and Physical Education, University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

May 25, 2016

First Posted

June 15, 2016

Study Start

May 1, 2016

Primary Completion

September 1, 2017

Study Completion

February 1, 2018

Last Updated

March 29, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations