NCT03903601

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Gdansk University of Physical Education and Sport · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

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.

Conditions

• Vascular Diseases
• Leukoaraiosis
• Ischemia, Cerebral

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Magnetic Resonance Imaging (MRI)	Magnetic Resonance Imaging (MRI) to diagnose ischemic changes in the brain.
DIAGNOSTIC_TEST	Blood samples collection	Trimethylamine N-oxide (TMAO) concentration, oxidative stress markers and endothelial dysfunction markers will be determined in blood samples.
DIAGNOSTIC_TEST	Neuropsychological tests	Cognitive functions assessment

Timeline

• Start date: 2021-12-30
• Primary completion: 2022-04-30
• Completion: 2022-05-01
• First posted: 2019-04-04
• Last updated: 2021-07-20

Locations

1 site across 1 country: Poland