Actively Recruiting
Oriental Intervention for Enhanced Neurocognitive Health (ORIENT) Diet in Patients With Intracranial / Carotid Stenosis: a Randomized Controlled Trial
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-06-15
120
Participants Needed
1
Research Sites
210 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
Oriental Intervention for Enhanced Neurocognitive Health (ORIENT) Diet in Patients With Intracranial / Carotid Stenosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 40 years or older
- At least 50% narrowing in one intracranial or carotid artery
- Written informed consent provided
- Willing to complete all assessments and follow-up
- Adequate vision and hearing to complete cognitive testing
You will not qualify if you...
- History of major head trauma or intracranial surgery
- Intracranial abnormalities like hemorrhage or space-occupying lesions
- Movement disorders or mental illnesses affecting cognitive testing
- Severe loss of vision, hearing, or communication ability
- Allergies to nuts, berries, olive oil, or fish
- Malignant disease with life expectancy less than 3 years
- Currently participating in another investigational drug study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive either the ORIENT diet intervention combined with standard medical treatment or usual diet advice with standard medical treatment for 6 months.
Visits at baseline and 6 months for assessments including neuropsychological testing and MRI scans
Duration - Up to 2 years
Participants are monitored for up to 2 years to assess long-term outcomes such as cognitive function, stroke incidence, and metabolite profiles.
Follow-up visits at 6 months and 2 years
Trial Site Locations
Total: 1 location
1
Second Affilated Hospital of Zhejiang University, School of Medicine
Hangzhou, Zhejiang, China, 310009
Actively Recruiting
Research Team
M
Min Lou, PhD, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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