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Concentration of Trimethylamine Oxide (TMAO) in Blood Plasma as a Risk Factor for Vascular Cerebral Damage

Concentration of Trimethylamine Oxide (TMAO) in Blood Plasma as a Risk Factor for Vascular Cerebral Damage

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03903601
Enrollment
300
Registered
2019-04-04
Start date
2021-12-30
Completion date
2022-05-31
Last updated
2021-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemia, Cerebral, Leukoaraiosis, Vascular Diseases

Keywords

trimethylamine-N-oxide, magnetic resonance imaging, cognitive functions

Brief summary

The primary aim of the current research project is to answer the question, whether plasma trimethylamine N-oxide (TMAO) level may be used as a marker of ischemic changes in the brain. TMAO is associated with endothelial dysfunction, inflammation and oxidative stress. The hypothesis is that circulating TMAO level may predict leukoaraiosis (LA) and/or stroke. Secondary, the investigators would like to examine whether plasma TMAO concentration is related to cognitive impairment and determine whether choline consumption is associated with an incidence of LA severity and dementia.

Detailed description

In the study, subjects will be recruited in the hospital among the patients with brain MRI performed within past 4 weeks. All MRI scans will be reviewed by the neurologist to evaluate ischemic changes. Upon detection of LA, patients (n=150) will be informed about the study aims. In the same time, aged- and sex-matched control group (n=150) with no detected ischemic changes will be recruited. In each group, the blood samples will be collected, to determine the concentration of plasma TMAO, oxidative stress markers, as well as serum endothelial dysfunction markers and biochemical parameters. To determine the cognitive performance psychological test will be carried out. The diet of all recruited participants, with special consideration on the choline-rich products and supplements, will be analyzed.

Interventions

DIAGNOSTIC_TESTMagnetic Resonance Imaging (MRI)

Magnetic Resonance Imaging (MRI) to diagnose ischemic changes in the brain.

Trimethylamine N-oxide (TMAO) concentration, oxidative stress markers and endothelial dysfunction markers will be determined in blood samples.

DIAGNOSTIC_TESTNeuropsychological tests

Cognitive functions assessment

Sponsors

Gdansk University of Physical Education and Sport
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes

Inclusion criteria

* the ischemic changes in the brain (diagnosed by neurologist by MRI scans)

Exclusion criteria

* no ischemic changes in the brain (diagnosed by neurologist by MRI scans)

Design outcomes

Primary

MeasureTime frameDescription
Brain Magnetic Resonance Imaging (MRI)before qualifying for the study, during the recruitment periodLeukoaraiosis severity will be evaluated in MRI scans according to the Fazekas' scale. Will be grading scale for periventricular hyperintensities (PVH) and scale of deep white matter hyperintensities.
Trimethylamine-N-oxide (TMAO) blood concentrationup to 4 weeks after brain MRITMAO concentration determined by the ultra-performance liquid-chromatography tandem mass spectrometry (UPLC-MS/MS), marked in µmol/l.

Secondary

MeasureTime frameDescription
Brain-derived neurotrophic factor (BDNF)up to 4 weeks after brain MRIBDNF concentration determined in serum by ELISA method, marked in pg/mg.
Mini Mental State Examination (MMSE)up to 4 weeks after brain MRIMMSE is a screening tool for cognitive functions impairment.
Trail Making Test (TMT)up to 4 weeks after brain MRITMT test to determine the executive functions.

Countries

Poland

Contacts

Primary ContactRobert A Olek, PhD
robol@awf.gda.pl58 5547392

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026