Second Affiliated Hospital, Zhejiang University, School of Medicine
Phase
Not applicable
Started
2023-11-01
Last updated
2025-06-15
Condition(s) studied
High Risk of Stroke
Investigational drug(s) / intervention(s)
Usual Diet adviceORIENT diet intervention
Usual Diet advice: The usual diet advice include recommendations in guidelines, such as reducing salt and fat intake.
ORIENT diet intervention: The ORIENT diet has the same basic components of the Dietary Approaches to Stop Hypertension (DASH), Mediterranean and MIND diets, but uniquely adjusting some of components according to the evidence derived from Asian prospective cohorts and the Chinese eating habits.
Study summary
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
Sex
ALL
Min age
40 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* Intracranial abnormalities, such as intracerebral hemorrhage, subarachnoid hemorrhage and other space occupying lesions
* Extrapyramidal symptoms or mental illness which may affect neuropsychological measurement
* Severe loss of vision, hearing, or communicative ability
* Patients presenting a malignant disease with life expectancy \< 3 years
* Participation in an ongoing investigational drug study
* 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
Primary outcome measure(s)
Changes in brain functional network connectivity assessed by resting state functional magnetic resonance imaging (fMRI) — 6 months Primary Outcome
Trial sites (1)
Facility
City
Region
Status
Second Affilated Hospital of Zhejiang University, School of Medicine
Hangzhou
Zhejiang
Recruiting
More Second Affiliated Hospital, Zhejiang University, School of Medicine trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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