Taking people in ChinaNo phase
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.
Key facts
- Who runs it
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Where
- Hangzhou, ChinaSee the site
- Trial code
- Registry title
- Oriental Intervention for Enhanced Neurocognitive Health (Orient) Diet in Populations With High Risk of Stroke (ENDS)
- Status
- Recruiting
- People taking part
- 160 people, planned
- Started
- 1 Nov 2023
- Planned end
- 30 Jun 2026
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Usual Diet advice
- ORIENT diet intervention
- Record updated
- 15 June 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 40 or older without dementia who are at high risk of stroke. It tests the ORIENT diet against usual diet advice.
- Age
- 40 years or older
- Sex
- Men and women
- Disease stage
- High risk of stroke: at least 3 of 8 risk factors (high blood pressure, abnormal blood fats, diabetes, atrial fibrillation or valvular heart disease, smoking history, obvious overweight or obesity, lack of exercise, family history of stroke), or a transient ischemic attack.
Main reasons for not taking part
- Allergy to nuts, berries, olive oil or fish
- Dementia, or suspected dementia at screening
- Major head trauma or any brain surgery in the past
- Bleeding or space-occupying lesions inside the skull
- Any reason that makes MRI unsafe
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in China
- Second Affilated Hospital of Zhejiang University, School of MedicineHangzhou, ChinaContact: Min Lou, PhD, MDTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Usual diet advicePlacebo, for comparison
- ORIENT diet interventionExisting treatment, for comparison
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Oriental Intervention for Enhanced Neurocognitive Health (Orient) Diet in Populations With High Risk of Stroke (ENDS): a Randomized Controlled Trial
- Plain-language title
- Testing the ORIENT diet in adults over 40 at high risk of strokeGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 15 June 2025