Healthy Clinical Trial
Official title:
Kinetics of Metabolic Cofactors After Oral Supplementation in Healthy Subjects
There is a strong correlation between major adverse health consequences of obesity and
development of non-alcoholic fatty liver disease (NAFLD). NAFLD is characterized by abnormal
hepatic accumulation of triglycerides and other lipids. It has become a worldwide health
problem that accelerates cirrhosis, type 2 diabetes mellitus (T2DM), and especially premature
cardiovascular morbidity and mortality.
The plasma level of glutathione (GSH) is typically depleted in individuals with metabolism
related disorders. However, cellular GSH levels cannot be increased by supplementing GSH and
it must be synthesized within the liver either de novo or by salvation pathway. The level of
GSH is not enough to maintain and regulate the thiol redox status of the liver in subjects
with high hepatic steatosis at fasting stage due to the depletion of glycine. Glycine can be
synthesized via the interconversion of serine. It has been shown that the serine synthesis is
downregulated in patients with NAFLD and supplementation of serine has attenuated alcoholic
fatty liver by enhancing homocysteine metabolism in mice and rats. Depleted liver glutathione
is also restored by the administration of N-acetylcystein as in acetaminophen poising.
L-carnitine and nicotinamide that both stimulate the transfer of fatty acids from cytosol to
mitochondria have been identified as two additional cofactors that are depleted in patients
with NAFLD.
In this study, the kinetics in blood of pivotal metabolic cofactors, serine, L-carnitine,
N-acetylcystein and nicotinamide after single and simultaneous dietary supplementation, are
measured.
In 10 healthy subjects with BMI <30 kg/m2 the plasma concentrations of 4 natural compounds
(nicotinamide riboside, L-carnitine, L-serine and N-acetylcystein) are measured by
ultra-performance liquid chromatography-tandem mass spectrometry (UPLCMSMS) after individual
and combined administration, on five consecutive days and at every hour during 9 hours after
administration. The study will start at 8:00 every morning and at each time point, blood
samples will be collected.
The taste and any potential sensing of the co-factors such as vertigo, nausea, bowel movement
will be recorded.
Each participant will receive one oral dose of Day 1: 1 g nicotinamide riboside; Day 2: 3 g
L-carnitine; Day 3: 5 g N-acetylcystein; Day 4: 20 g L-serine; Day 5: combined 1 g
nicotinamide riboside, 3 g L-carnitine, 5 g N-acetylcystein, and 20 g L-serine
In addition, untargeted metabolomics analysis as well as O-link proteomics analysis we be
performed to study effect of the administered cofactors.
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