Oriental Intervention for Enhanced Neurocognitive Health (Orient) Diet in Populations With High R… (NCT06098235) | Clinical Trial Compass
RecruitingNot Applicable
Oriental Intervention for Enhanced Neurocognitive Health (Orient) Diet in Populations With High Risk of Stroke (ENDS)
China160 participantsStarted 2023-11-01
Plain-language 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.
Who can participate
Age range40 Years
SexALL
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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
What they're measuring
1
Changes in brain functional network connectivity assessed by resting state functional magnetic resonance imaging (fMRI)
Timeframe: 6 months
Trial details
NCT IDNCT06098235
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University