Metabolic Availability of Tryptophan From White Maize

November 11, 2016 updated by: Glenda Courtney-Martin, The Hospital for Sick Children

Application of the Indicator Amino Acid Oxidation Technique for the Determination of Metabolic Availability of Tryptophan From White Maize Protein, in Young Adult Men

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Our objective is to determine the metabolic availability of Tryptophan in white maize. Seven young, healthy, male adults will receive graded levels (13.2, 26.4, 39.7, 52.9) of tryptophan requirement of 3.78 mg/kg/d as a crystalline amino acid (AA) mixture and a porridge of white cornmeal protein respectively.

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • The Hospital for Sick Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 49 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tryptophan Amino Acid
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metabolic Availability of Tryptophan in Corn
Time Frame: 9 hours
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Investigators

  • Principal Investigator: Paul Pencharz, MD, PhD,, Senior Scientist

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

March 19, 2015

First Submitted That Met QC Criteria

March 24, 2015

First Posted (Estimate)

March 30, 2015

Study Record Updates

Last Update Posted (Estimate)

November 15, 2016

Last Update Submitted That Met QC Criteria

November 11, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1000048461

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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