NCT03696264

Brief Summary

In this study, the investigators will use the minimally invasive indicator amino acid oxidation (IAAO) technique to determine protein requirements in resistance-trained males. It is hypothesized that the present study will show that protein requirements for resistance-trained males are i) greater than the current recommended dietary allowance (RDA) for non-active individual's comparable estimates, and ii) greater than existing nitrogen balance-based estimates for resistance-training individuals.

Trial Health

87
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 healthy

Timeline
Completed

Started Mar 2017

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

March 6, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 1, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 4, 2018

Completed
Last Updated

October 4, 2018

Status Verified

October 1, 2018

Enrollment Period

4 months

First QC Date

October 1, 2018

Last Update Submit

October 2, 2018

Conditions

Keywords

Protein Requirements

Outcome Measures

Primary Outcomes (1)

  • Phenylalanine excretion

    Expressed as µmol/kg/h; phenylalanine excretion is determined via breath enrichment of the oral tracer

    Through study completion, an average of 1 year

Secondary Outcomes (2)

  • Phenylalanine rate of appearance

    Through study completion, an average of 1 year

  • Net Protein Balance

    Through study completion, an average of 1 year

Study Arms (1)

Resistance-trained, adult males

EXPERIMENTAL

Subjects receive varying levels of amino acid intakes ranging from 0.2-3.0g/kg/d

Dietary Supplement: Amino acid intake

Interventions

Amino acid intakeDIETARY_SUPPLEMENT

Amino acid intake will range between 0.2-3.0g/kg/d

Resistance-trained, adult males

Eligibility Criteria

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

You may qualify if:

  • Healthy, male weight-trained individuals that have trained consistently for \>1 year.
  • years old.
  • Train each muscle group (i.e. chest, back, legs) at least twice a week.
  • Body mass stable in last month
  • Meets strength relative to body weight guidelines (see below)
  • Bench Press:
  • Males- body weight (kg)\*1.25
  • Leg Press:
  • Males- body weight (kg)\* 4.0

You may not qualify if:

  • Inability to meet health and physical activity guidelines according to the Physical Activity Readiness Questionnaire
  • Inability to adhere to any of the protocol guidelines (i.e. alcohol, caffeine consumption)
  • Regular tobacco use
  • Illicit drug use (e.g. growth hormone, testosterone, etc.) (screened by survey sheet for training log
  • \>1 month sedentary in the last 6 months prior to study participation
  • \>30 min of continuous cardio per exercise session
  • BMI (Body Mass Index) \> 35.
  • Individual plans to increase or decrease body mass in the next 3 months
  • Habitually ingests greater than or equal to 3g protein kg/bw/day
  • Use of supplements such as creatine and beta-alanine in the last 30 days.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Goldring Centre for High Performance Sport

Toronto, Ontario, M5S2C9, Canada

Location

Related Publications (6)

  • Thomas DT, Erdman KA, Burke LM. Position of the Academy of Nutrition and Dietetics, Dietitians of Canada, and the American College of Sports Medicine: Nutrition and Athletic Performance. J Acad Nutr Diet. 2016 Mar;116(3):501-528. doi: 10.1016/j.jand.2015.12.006.

    PMID: 26920240BACKGROUND
  • Phillips SM. Protein requirements and supplementation in strength sports. Nutrition. 2004 Jul-Aug;20(7-8):689-95. doi: 10.1016/j.nut.2004.04.009.

    PMID: 15212752BACKGROUND
  • Rand WM, Pellett PL, Young VR. Meta-analysis of nitrogen balance studies for estimating protein requirements in healthy adults. Am J Clin Nutr. 2003 Jan;77(1):109-27. doi: 10.1093/ajcn/77.1.109.

    PMID: 12499330BACKGROUND
  • Humayun MA, Elango R, Ball RO, Pencharz PB. Reevaluation of the protein requirement in young men with the indicator amino acid oxidation technique. Am J Clin Nutr. 2007 Oct;86(4):995-1002. doi: 10.1093/ajcn/86.4.995.

    PMID: 17921376BACKGROUND
  • Tarnopolsky MA, Atkinson SA, MacDougall JD, Chesley A, Phillips S, Schwarcz HP. Evaluation of protein requirements for trained strength athletes. J Appl Physiol (1985). 1992 Nov;73(5):1986-95. doi: 10.1152/jappl.1992.73.5.1986.

    PMID: 1474076BACKGROUND
  • Mazzulla M, Abou Sawan S, Williamson E, Hannaian SJ, Volterman KA, West DWD, Moore DR. Protein Intake to Maximize Whole-Body Anabolism during Postexercise Recovery in Resistance-Trained Men with High Habitual Intakes is Severalfold Greater than the Current Recommended Dietary Allowance. J Nutr. 2020 Mar 1;150(3):505-511. doi: 10.1093/jn/nxz249.

Study Officials

  • Daniel R Moore, PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Participants blinded to the protein dose consumed in a given metabolic trial
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 1, 2018

First Posted

October 4, 2018

Study Start

March 6, 2017

Primary Completion

July 1, 2017

Study Completion

October 31, 2017

Last Updated

October 4, 2018

Record last verified: 2018-10

Locations