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Testing the ORIENT diet in adults over 40 at high risk of stroke

Tests the ORIENT diet against usual diet advice in people at high risk of stroke.

Plain-language title generated from the registry record
Registry title: Oriental Intervention for Enhanced Neurocognitive Health (Orient) Diet in Populations With High Risk of Stroke (ENDS)

Key facts

Where
Hangzhou, ChinaSee the site

Where in China

  • Second Affilated Hospital of Zhejiang University, School of MedicineHangzhou, ChinaTaking people

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Trial details

Who runs it
Second Affiliated Hospital, Zhejiang University, School of Medicine
Trial code
NCT06098235
Record updated
15 June 2025
Original description
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 the impact of the ORIENT diet on brain functional networks.Read full original descriptionShow less

Oriental Intervention for Enhanced Neurocognitive Health (Orient) Diet in Populations With High Risk of Stroke (ENDS): a Randomized Controlled Trial

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 the impact of the ORIENT diet on brain functional networks.

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: previously diagnosed dementia; Previous history of major head trauma and any intracranial surgery; Participation in an ongoing investigational drug study; Nuts, berries, olive oil, or fish allergies; Suspected dementia after clinical assessment by study physician at screening visit; Intracranial abnormalities, such as intracerebral hemorrhage, subarachnoid hemorrhage and other space occupying lesions; Extrapyramidal symptoms or mental illness which may affect neuropsychological measurement; Patients presenting a malignant disease with life expectancy < 3 years; Severe loss of vision, hearing, or communicative ability; 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.

ClinicalTrials.gov NCT06098235