๐ฌIn plain words
What the trial is, and whether it could suit you
To test the effects of 6 month additional intervention of ORIENT diet versus usual medical treatment for Intracranial / Carotid Stenosis on cognitive decline, multi-mode MRI image markers and serum and fecal biomarkers in a randomized controlled trial of 120 patients with intracranial / carotid stenosis, who are aged older than 40 years and without dementia.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
* Patients aged โฅ 40 years
* โฅ 50% stenosis in unilateral intracranial / carotid artery
* Written informed consent available
* Willingness to complete all assessments and participate in follow-up
* Adequate Visual and auditory acuity to undergo neuropsychological testing
Exclusion Criteria:
* Previous history of major head trauma and any intracranial surgery
* Intracranial abnormalities, such as intracerebral hemorrhage, subarachnoid hemorrhage and other space occupying lesions
* Extrapyramidal symptoms or mental illness which may affect neuropsychological measurement
* Severe loss of vision, hearing, or communicative ability
* Nuts, berries, olive oil, or fish allergies
* Patients presenting a malignant disease with life expectancy \< 3 years
* Participation in an ongoing investigational drug study
Exit Criteria:
* Not meet the inclusion criteria
* For any poor adherence, not comply with the requirements of the follow-up, or safety reasons determined by investigator
* Any adverse or serious adverse events during the study period judged by Investigator
๐
What it tests
- Usual Diet advice
- Oriental Intervention for Enhanced Neurocognitive Health (ORIENT) diet
Second Affilated Hospital of Zhejiang University, School of Medicine
Hangzhou, China
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.