Oriental Intervention for Enhanced Neurocognitive Health (ORIENT) Diet in Patients With Intracranial / Carotid Stenosis
Recruiting now · Not applicable
Conditions studied: Cognitive Decline, Cognitive Change, Stenosis, Dementia
In brief
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.
Key facts
- Study ID
- NCT05922137
- Run by
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- People needed
- 120
- Starts
- 2023-05-01
- Expected to finish
- 2027-05-31
- Last updated by the study team
- 2025-06-15
Who can join
Age: 40 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients aged ≥ 40 years
- ≥ 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
You may not qualify if…
- 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
Where it is running
- Second Affilated Hospital of Zhejiang University, School of Medicine — Hangzhou, Zhejiang, China (enrolling)
Full record on ClinicalTrials.gov
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