Actively Recruiting

Phase Not Applicable
Age: 40Years +
All Genders
NCT06098235

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

Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-06-15

160

Participants Needed

1

Research Sites

138 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 40Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 240 years or older
  • High risk of stroke with three or more of the following risk factors: hypertension, dyslipidemia, diabetes, atrial fibrillation or valvular heart disease, smoking history, obvious overweight or obesity, lack of exercise, family history of stroke, or history of transient ischemic attack
  • Written informed consent provided
  • Willingness to complete all assessments and follow-up participation
  • Adequate vision and hearing to complete neuropsychological testing
Not Eligible

You will not qualify if you...

  • Allergies to nuts, berries, olive oil, or fish
  • Previous diagnosis of dementia
  • Suspected dementia after clinical assessment at screening
  • Previous major head trauma or any intracranial surgery
  • Intracranial abnormalities such as hemorrhages or space occupying lesions
  • Extrapyramidal symptoms or mental illness affecting neuropsychological testing
  • Severe loss of vision, hearing, or communication ability
  • Malignant disease with life expectancy less than 3 years
  • Participation in another investigational drug study
  • Any contraindications for MRI
  • Poor adherence, inability to comply with follow-up, or safety concerns during the study
  • Any adverse or serious adverse events during the study as judged by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Second Affilated Hospital of Zhejiang University, School of Medicine

Hangzhou, Zhejiang, China, 310009

Actively Recruiting

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Research Team

M

Min Lou, PhD, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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