Oriental Intervention for Enhanced Neurocognitive Health (ORIENT) Diet in Patients With Intracranial / Carotid Stenosis
Oriental Intervention for Enhanced Neurocognitive Health (ORIENT) Diet in Patients With Intracranial / Carotid Stenosis : a Randomized Controlled Trial
Second Affiliated Hospital, School of Medicine, Zhejiang University
120 participants
May 1, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria7
- 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
- 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
Exclusion Criteria8
- 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:
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Interventions
The usual diet advice include recommendations in guidelines, such as reducing salt and limiting alcohol consumption
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05922137