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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
Usual Diet advice
BehavioralThe usual diet advice include recommendations in guidelines, such as reducing salt and fat intake.
ORIENT diet intervention
BehavioralThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Changes in brain functional network connectivity assessed by resting state functional magnetic resonance imaging (fMRI)
Primary Outcome
Secondary outcomes
Changes in brain functional network efficiency assessed by resting state fMRI
long-term secondary outcome
Changes in brain functional network activity intensity assessed by resting state fMRI
long-term secondary outcome
Changes in brain functional network efficiency assessed by resting state fMRI
long-term secondary outcome
Changes in brain functional network activity intensity assessed by resting state fMRI
long-term secondary outcome
Sponsors and contacts
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