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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.

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

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data 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