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NCT06098235Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 15 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
160 (estimated)
First submitted
11 Sept 2023
Start date
1 Nov 2023
Primary completion date
1 Nov 2025
Lead sponsor
Second Affiliated Hospital, Zhejiang University, School of Medicine
Diseases
Stroke
NCT number
NCT06098235

What you commit to

  • Study type: Interventional
  • Planned participants: 160
  • From 1 Nov 2023 to the primary completion date, 1 Nov 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • previously diagnosed dementia
  • Previous history of major head trauma and any intracranial surgery
  • Participation in an ongoing investigational drug study

Other illness

  • 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

Age

  • Patients presenting a malignant disease with life expectancy \< 3 years

Other

  • 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

Who the study is looking for

  • 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

Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Second Affilated Hospital of Zhejiang University, School of Medicine
Coordinator of this site? Confirm its status
HangzhouChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.