Healthy Clinical Trial
Official title:
The Effect of Acute Lysine Administration on α-aminoadipic Acid
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 significance of diabetes and related co-morbidities as considerable health concerns in
the US and worldwide is clearly supported by the high incidence (estimated 9.3% of the US
population), mortality burden (7th leading cause of death in the US), and rising costs ($245
billion/year). Strategies to identify individuals at high diabetic risk, and to modulate
disease processes in these individuals before the onset of overt disease, would have a
significant impact in reducing mortality, morbidity and healthcare costs. For this approach
to be successful, early markers of disease that predict at-risk individuals before onset of
dysregulated glycemic control are required, as well as discovering novel pathways for
therapeutic targeting.
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.
The investigators specific aim is to determine whether acute lysine administration leads to
increased plasma 2-AAA in humans. Catabolism of lysine leads to generation of 2-AAA. In this
study, the investigators will determine whether a single dose of lysine leads to increased
plasma 2-AAA present in the blood and urine of humans. The investigators will ask 10 lean,
healthy subjects to drink a beverage containing lysine and the investigators will measure
the level of 2-AAA in their blood plasma and urine at baseline (before ingestion) and
serially post-ingestion. The amount of lysine subjects will be given is equivalent to that
which is found in a 10 oz. serving of beef. This pilot study will allow us to establish the
relationship between lysine and 2-AAA in healthy subjects, and inform future studies on how
to study the effects of 2-AAA on diabetes risk.
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