## Protocol Section
### Identification Module
**NCT ID:** NCT02402179

**Brief Title:** Metabolic Availability of Tryptophan From White Maize

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

#### Organization Study ID Info
**ID:** 1000048461
#### Organization
**Class:** OTHER
**Full Name:** The Hospital for Sick Children
### Status Module
#### Completion Date
**Date:** 2016-05

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2016-11-15

**Type:** ESTIMATED

**Last Update Submit Date:** 2016-11-11

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2016-04

**Type:** ACTUAL

#### Start Date
**Date:** 2015-03

**Status Verified Date:** 2016-11

#### Study First Post Date
**Date:** 2015-03-30
**Type:** ESTIMATED
**Study First Submit Date:** 2015-03-19
**Study First Submit QC Date:** 2015-03-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** The Hospital for Sick Children

#### Responsible Party

**Investigator Affiliation:** The Hospital for Sick Children

**Investigator Full Name:** Glenda Courtney-Martin

**Investigator Title:** Assistant Professor, Faculty of Kinesiology and Physical Education, U of Toronto; Project Investigator, Research Institute The Hospital for Sick Children

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

**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.

### Conditions Module

**Conditions:**

- Healthy

**Keywords:**

- protein quality

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** HEALTH_SERVICES_RESEARCH

#### Enrollment Info

**Count:** 7

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Other: Tryptophan

**Label:** Tryptophan Amino Acid

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Tryptophan Amino Acid

**Description:** 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.

**Name:** Tryptophan

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Metabolic Availability of Tryptophan in Corn

**Time Frame:** 9 hours

### Eligibility Module

**Eligibility Criteria:** 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.

**Healthy Volunteers:** True

**Maximum Age:** 49 Years

**Minimum Age:** 20 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Toronto

**Country:** Canada

**Facility:** The Hospital for Sick Children

**State:** Ontario

#### Overall Officials

**Official 1:**

**Affiliation:** Senior Scientist

**Name:** Paul Pencharz, MD, PhD,

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** 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. Erratum In: J Nutr. 2018 Oct 1;148(10):1698.

**PMID:** 29741697

## Derived Section

### Intervention Browse Module - Ancestors

- ID: D000018687

- Term: Antidepressive Agents, Second-Generation

- ID: D000000928

- Term: Antidepressive Agents

- ID: D000011619

- Term: Psychotropic Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: PsychDr

- Name: Psychotropic Drugs

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: AA

- Name: Amino Acids

### Intervention Browse Module - Browse Leaves

- ID: M17115

- Name: Tryptophan

- Relevance: HIGH

- As Found: Freezing

- ID: M4247

- Name: Antidepressive Agents

- Relevance: LOW

- As Found: Unknown

- ID: M14474

- Name: Psychotropic Drugs

- Relevance: LOW

- As Found: Unknown

- ID: T21

- Name: Tryptophan

- Relevance: HIGH

- As Found: Freezing

### Intervention Browse Module - Meshes

- ID: D000014364

- Term: Tryptophan

### Misc Info Module

- Version Holder: 2024-05-24
