Overview

This trial has been completed.

Condition healthy adults
Treatments crystalline lysine amino acid mix, white corn meal porridge
Phase phase 1
Sponsor The Hospital for Sick Children
Start date December 2013
End date May 2016
Trial size 7 participants
Trial identifier NCT02018575, 0019850580 amendment

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification bio-availability study
Intervention model single group assignment
Masking open label
Primary purpose health services research
Arm
(Experimental)
Randomly selected levels of lysine intake which are lower than the lysine requirement (previously derived).
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.
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.

Primary Outcomes

Measure
Metabolic Availability of Lysine
time frame: Baseline

Secondary Outcomes

Measure
Metabolic Availability of Lysine
time frame: 15 mins after intake of the fourth hourly meal (before tracer infusion)

Eligibility Criteria

Male participants from 20 years up to 49 years old.

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

Additional Information

Official title Application of the Indicator Amino Acid Oxidation Technique for the Determination of Metabolic Availability of Lysine From White Maize Protein, in Young Adult Men
Principal investigator Paul B Pencharz, MD, PhD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by The Hospital for Sick Children.