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This study aims to assess the effect and breakdown of lysine administration, specifically examining whether it leads to increased plasma 2-AAA in healthy humans.
The purpose of this study is to investigate a novel biomarker, α-aminoadipic acid (2-AAA), which may influence the risk of diabetes. 2-AAA has been identified as a novel predictor of diabetes development in humans, identifying at-risk individuals before any detectable glucose abnormalities. 2-AAA is a naturally occurring metabolite in the body, and it has no known adverse effects at normal physiological levels. 2-AAA is generated in the body from the breakdown of lysine. Lysine is one of the twenty essential amino acids, meaning that it is essential for human function, but that our body cannot manufacture it. Thus, it is acquired from dietary sources (such as meat, eggs, soybeans and legumes), with a recommended daily intake of 30 mg/kg/day. Amino acids are the building blocks of proteins, which are what allow our cells, organs and body to maintain structure and function. The investigators are interested in whether 2-AAA is increased in the body after consumption of lysine.
Age
18 - 50 years
Sex
ALL
Healthy Volunteers
Yes
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Start Date
March 9, 2022
Primary Completion Date
January 27, 2023
Completion Date
January 27, 2023
Last Updated
June 5, 2024
23
ACTUAL participants
L-Lysine
DRUG
Normal Saline
DRUG
Lead Sponsor
Vanderbilt University Medical Center
NCT06959901
NCT06574035
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT06861062