Oriental Intervention for Enhanced Neurocognitive Health (Orient) Diet in Populations With High Risk of Stroke (ENDS)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this 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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Usual Diet advice
  • ORIENT diet intervention

Treatment groups

160 Participants
are divided into 2 treatment groups