NCT02402179

Brief Summary

Our objective is to determine the metabolic availability of Tryptophan in white maize using the indicator amino acid oxidation (IAAO) technique in adult men.

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 2015

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

March 1, 2015

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 30, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

November 15, 2016

Status Verified

November 1, 2016

Enrollment Period

1.1 years

First QC Date

March 19, 2015

Last Update Submit

November 11, 2016

Conditions

Keywords

protein quality

Outcome Measures

Primary Outcomes (1)

  • Metabolic Availability of Tryptophan in Corn

    The quality of corn protein will be assessed by measuring the amount of its tryptophan available for protein synthesis (metabolic availability) using the slope ration method. The oxidation of the indicator amino acid phenylalanine will be measured in response to feeding graded intakes of tryptophan in a reference protein patterned after egg protein, and provided as a crystalline amino acid mixture. The pattern of oxidation of phylalanine in response to tryptophan provided in corn will be compared to the pattern of oxidation obtained from feeding the reference protein. On each study day, subjects will be fed 8 hourly meals and breath samples will be taken to measure the oxidation of phenylalanine. Samples will be collected at baseline after the fourth meal, and half hourly, beginning 2.5 hrs after the 5th meal. Breath samples will be analyzed for 13CO2 enrichment.

    9 hours

Study Arms (1)

Tryptophan Amino Acid

EXPERIMENTAL

13.2, 26.4, 39.7, 52.9% of the mean tryptophan requirement of 3.78 mg/kg/d will be given to subjects.

Other: Tryptophan

Interventions

Tryptophan will be supplied at 13.2, 26.4, 39.7, or 52.9% of requirement; sourced from crystalline amino acid and white cornmeal maize.

Tryptophan Amino Acid

Eligibility Criteria

Age20 Years - 49 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy Adult males (20-49years old).
  • Stable body weight
  • Not on any medications that could affect protein and amino acid metabolism e.g. steroids.

You may not qualify if:

  • Recent weight loss within the last 3 months or on weight reducing diet.
  • Unwillingness to participate or unable to tolerate the diet.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, Canada

Location

Related Publications (1)

  • Rafii M, Elango R, Ball RO, Pencharz PB, Courtney-Martin G. Metabolic Availability of the Limiting Amino Acids Lysine and Tryptophan in Cooked White African Cornmeal Assessed in Healthy Young Men Using the Indicator Amino Acid Oxidation Technique. J Nutr. 2018 Jun 1;148(6):917-924. doi: 10.1093/jn/nxy039.

MeSH Terms

Interventions

Tryptophan

Intervention Hierarchy (Ancestors)

Amino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Essential

Study Officials

  • Paul Pencharz, MD, PhD,

    Senior Scientist

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Faculty of Kinesiology and Physical Education, U of Toronto; Project Investigator, Research Institute The Hospital for Sick Children

Study Record Dates

First Submitted

March 19, 2015

First Posted

March 30, 2015

Study Start

March 1, 2015

Primary Completion

April 1, 2016

Study Completion

May 1, 2016

Last Updated

November 15, 2016

Record last verified: 2016-11

Locations