NCT02009917

Brief Summary

Protein is a major structural component of all cells in the body. The nutritional importance of protein is because of their amino acids. 9 are called essential and 11 are called non-essential, based on whether we need to get them from diet. This classification is based on studies done using older techniques. Recent studies suggest that these so called non-essential amino acids play important roles in our body's health. For the first time, this proposal defines an experimental design to examine non- essential amino acid/nitrogen requirements and metabolism in humans using the Indicator Amino Acid Oxidation (IAAO) technique. The objective of the current study is to examine the application of IAAO technique to determine the non-essential amino acid/nitrogen requirement in adult humans.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2013

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

October 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 12, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

July 18, 2017

Status Verified

July 1, 2017

Enrollment Period

1.3 years

First QC Date

December 9, 2013

Last Update Submit

July 13, 2017

Conditions

Keywords

Indicator Amino Acid OxidationNon essential Amino acidsProteinAmino acid

Outcome Measures

Primary Outcomes (1)

  • 13 Carbon dioxide production

    Urine and breath samples will be collected to measure the rate of oxidation of expired breath and flux by enrichment of urine.

    8 hours (1study day)

Eligibility Criteria

Age20 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Physiologically Healthy Adult males, 20-40 years of age

You may qualify if:

  • years of age
  • Male
  • Classified as normal body weight based on body mass index (BMI) 18.5-25kg/m2
  • Free of any concurrent illness

You may not qualify if:

  • Men not in good health or have a metabolic, neurological, genetic or immune disorder including diabetes and hypertension
  • Men who are classified as underweight(\<18.5kg/m2), overweight(25-30kg/m2) or obese (\>30kg/m2) using the BMI classification)
  • Men who are allergic to milk, eggs and egg protein

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Child and Family Research Institute

Vancouver, British Columbia, V5Z4H4, Canada

Location

Related Publications (1)

  • Cooper L, Ball RO, Pencharz PB, Sakai R, Elango R. Dispensable Amino Acids, except Glutamine and Proline, Are Ideal Nitrogen Sources for Protein Synthesis in the Presence of Adequate Indispensable Amino Acids in Adult Men. J Nutr. 2020 Sep 1;150(9):2398-2404. doi: 10.1093/jn/nxaa180.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Breath and urine samples

Study Officials

  • Rajavel Elango, Ph.D

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

December 9, 2013

First Posted

December 12, 2013

Study Start

October 1, 2013

Primary Completion

January 1, 2015

Study Completion

April 1, 2015

Last Updated

July 18, 2017

Record last verified: 2017-07

Locations