Status:
RECRUITING
Oriental Intervention for Enhanced Neurocognitive Health (Orient) Diet in Populations With High Risk of Stroke (ENDS)
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
High Risk of Stroke
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
This randomized controlled trial will enroll 160 individuals aged over 40 without dementia who are at high risk of stroke, collecting multi-modal MRI imaging, serum, and fecal samples to investigate t...
Detailed Description
Oriental Intervention for Enhanced Neurocognitive Health (ORIENT) Diet in Populations with High Risk of Stroke is designed to test the impact of a 6-month intervention utilizing a culturally adapted v...
Eligibility Criteria
Inclusion
- Patients aged ≥ 40 years
- High risk of stroke (with ≥ 3 of 8 stroke risk factors, including hypertension, dyslipidemia, diabetes, atrial fibrillation or valvular heart disease, smoking history, obvious overweight or obesity, lack of exercise, family history of stroke, or with transient ischemic attack)
- Written informed consent available
- Willingness to complete all assessments and participate in follow-up
- Adequate Visual and auditory acuity to undergo neuropsychological testing
Exclusion
- Nuts, berries, olive oil, or fish allergies
- previously diagnosed dementia
- Suspected dementia after clinical assessment by study physician at screening visit
- 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
- Patients presenting a malignant disease with life expectancy \< 3 years
- Participation in an ongoing investigational drug study
- Any MRI contraindications
- 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
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT06098235
Start Date
November 1 2023
End Date
June 30 2026
Last Update
June 15 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Second Affilated Hospital of Zhejiang University, School of Medicine
Hangzhou, Zhejiang, China, 310009