Metabolic Availability of Lysine From White Maize

NCT ID: NCT02018575

Last Updated: 2016-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2016-05-31

Brief Summary

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

Detailed Description

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Our objective is to determine the metabolic availability of Lysine in white maize. 7 young, healthy, male adults will receive graded levels (29, 37,46 and 54%) of lysine requirement of 35 mg/kg/d as a crystalline AA mixture and a porridge of white cornmeal protein respectively.

Conditions

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Healthy Adults

Keywords

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lysine bioavailability amino acids corn

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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levels of lysine intake.

Randomly selected levels of lysine intake which are lower than the lysine requirement (previously derived).

Group Type EXPERIMENTAL

Crystalline Lysine Amino Acid Mix

Intervention Type DIETARY_SUPPLEMENT

Crystalline Lysine from Amino Acid Mixture in amount of 29, 37, 46 and 54% of the mean Lysine requirement of 35 mg/kg/d will be given to subjects.

White corn meal porridge

Intervention Type DIETARY_SUPPLEMENT

A cornmeal porridge including 29, 37, 46 and 54% of the mean Lysine requirement of 35 mg/kg/d will be given to subjects.

Interventions

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Crystalline Lysine Amino Acid Mix

Crystalline Lysine from Amino Acid Mixture in amount of 29, 37, 46 and 54% of the mean Lysine requirement of 35 mg/kg/d will be given to subjects.

Intervention Type DIETARY_SUPPLEMENT

White corn meal porridge

A cornmeal porridge including 29, 37, 46 and 54% of the mean Lysine requirement of 35 mg/kg/d will be given to subjects.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Healthy Adult males (20-49 years old)

Exclusion Criteria

* A history of recent weight loss or illness
* Use of any medication at the time of entry into the study
Minimum Eligible Age

20 Years

Maximum Eligible Age

49 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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The Hospital for Sick Children

OTHER

Sponsor Role lead

Responsible Party

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Dr. Paul Pencharz

Professor of Paediatrics and Nutritional Sciences (Emeritus) University of Toronto, Senior Scientist Research Institute, The Hospital for Sick Children

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paul B Pencharz, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children, Toronto, Canada

Locations

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The Hospital for Sick Children

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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0019850580 amendment

Identifier Type: -

Identifier Source: org_study_id