Study of the ORIENT Diet Combined With Standard Treatment to Improve Brain Health in Adults Over 40 With Intracranial or Carotid Artery Narrowing

What this Trial Is About

This trial is studying patients aged 40 years and older with intracranial or carotid artery stenosis of 50% or more, who do not have dementia. It aims to evaluate the effects of a culturally adapted diet called the ORIENT diet on cognitive decline, brain structure, and biological markers. The study involves 120 participants and focuses on how this diet may influence brain health compared to usual medical treatment alone. Participants are randomly assigned to one of two groups one group receives standard medical treatment plus usual diet advice, while the other group receives standard medical treatment combined with the ORIENT diet intervention for six months. The ORIENT diet incorporates elements from the DASH, Mediterranean, and MIND diets, with specific adjustments to match Asian dietary habits. During the study, participants will undergo neuropsychological testing and multi-modal MRI scans every six months to assess cognitive function and brain changes. Researchers will also collect blood and fecal samples to analyze biomarkers and gut microbiota. The primary outcome is the change in global cognitive function after six months. Secondary outcomes include detailed cognitive domain assessments, brain imaging markers, metabolite profiles, and stroke incidence. Participants will be monitored for adherence and safety throughout the study period, which extends up to two years for some measures.

Oriental Intervention for Enhanced Neurocognitive Health (ORIENT) Diet in Patients With Intracranial / Carotid Stenosis