Clinical trial NCT03903601: Concentration of Trimethylamine Oxide (TMAO) in Blood Plasma as a Risk Factor for Vascular Cerebral Damage
Official title: Concentration of Trimethylamine Oxide (TMAO) in Blood Plasma as a Risk Factor for Vascular Cerebral Damage
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vascular Diseases
Leukoaraiosis
Ischemia, Cerebral
Keywords: trimethylamine-N-oxide
magnetic resonance imaging
cognitive functions
Lead sponsor: Gdansk University of Physical Education and Sport
Sponsor class: OTHER
First posted: 2019-04-04
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from 7th Navy Hospital in Gdansk, which had a brain MRI performed within the past 4 weeks.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Brain Magnetic Resonance Imaging (MRI)
timeFrame: before qualifying for the study, during the recruitment period
measure: Trimethylamine-N-oxide (TMAO) blood concentration
timeFrame: up to 4 weeks after brain MRI
Secondary outcomes:
measure: Brain-derived neurotrophic factor (BDNF)
timeFrame: up to 4 weeks after brain MRI
measure: Mini Mental State Examination (MMSE)
timeFrame: up to 4 weeks after brain MRI
measure: Trail Making Test (TMT)
timeFrame: up to 4 weeks after brain MRI
Other outcomes:
Locations:
city: Gdansk
country: Poland
facility: University of Physical Education and Sport
state: Pomorskie
Study officials:
affiliation: Gdansk University of Physical Education and Sport
name: Robert A Olek, PhD
role: PRINCIPAL_INVESTIGATOR
References: