NCT03397043

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Nov 2016

Longer than P75 for not_applicable healthy

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

November 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 11, 2018

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
Last Updated

March 29, 2019

Status Verified

March 1, 2019

Enrollment Period

11 months

First QC Date

January 5, 2018

Last Update Submit

March 28, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Phenylalanine oxidation

    In µmol/kg/h, the product of F13CO2 and VCO2. F13CO2 is determined via breath enrichment analysis of 13CO2 after 1-13C phenylalanine ingestion, and VCO2 is determined via indirect calorimetry

    Through study completion: an average of 6 metabolic trials (days), each separated by approximately 1 week

Secondary Outcomes (2)

  • Phenylalanine rate of appearance

    Through study completion: an average of 6 metabolic trials (days), each separated by approximately 1 week

  • Net protein balance

    Through study completion: an average of 6 metabolic trials (days), each separated by approximately 1 week

Study Arms (1)

Healthy females

EXPERIMENTAL

All participants receive the intervention: Protein intake (dose). This consists of varying levels of dietary protein intakes, in the form of crystalline amino acids, ranging from 0.2-3.0 g/kg/d

Other: Protein intake (dose)

Interventions

Protein intake, in the form of crystalline amino acids, will range between 0.2-3.0 g/kg/d

Healthy females

Eligibility Criteria

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

You may qualify if:

  • healthy female weight-trained individuals that have trained consistently for \>1 year
  • complete a physical activity readiness questionnaire (PAR-Q+)
  • Train each muscle group (i.e. chest, back, legs) at least twice a week
  • Meets strength relative to body weight GUIDELINES adapted from Morton et al., 2016; Chilibeck et al., 1997 (sex specific).
  • Bench Press:
  • body weight (kg)\*0.7
  • Leg Press:
  • body weight (kg)\*2.3

You may not qualify if:

  • sedentary for greater than 1 month in the last 6 months prior to the study
  • non-weight stable for the past month
  • smoker
  • Illicit drug use (e.g. growth hormone, testosterone, etc.)
  • 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.
  • Inability to adhere to any of the protocol guidelines

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

January 5, 2018

First Posted

January 11, 2018

Study Start

November 1, 2016

Primary Completion

October 6, 2017

Study Completion

November 30, 2018

Last Updated

March 29, 2019

Record last verified: 2019-03