Second Affiliated Hospital, Zhejiang University, School of Medicine
Phase
Not applicable
Started
2023-05-01
Last updated
2025-06-15
Condition(s) studied
Cognitive DeclineCognitive ChangeStenosisDementia
Investigational drug(s) / intervention(s)
Usual Diet adviceOriental Intervention for Enhanced Neurocognitive Health (ORIENT) diet
Usual Diet advice: The usual diet advice include recommendations in guidelines, such as reducing salt and limiting alcohol consumption
Oriental Intervention for Enhanced Neurocognitive Health (ORIENT) diet: The ORIENT diet has the same basic components of the Dietary Approaches to Stop Hypertension (DASH), Mediterranean and MIND diets, but uniquely adjusting some of components according to the evidence derived from Asian prospective cohorts and the Chinese eating habits.
Study summary
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.
Eligibility
Sex
ALL
Min age
40 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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
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
Primary outcome measure(s)
Global cognitive function change assessed with Z-score of a modified National Institute of Neurological Disorders and Stroke and Canadian Stroke Network-Canadian Stroke Network (NINDS-CSN) protocol — 6 months Primary Outcome
Trial sites (1)
Facility
City
Region
Status
Second Affilated Hospital of Zhejiang University, School of Medicine
Hangzhou
Zhejiang
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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