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

Zhejiang University

Status

Enrolling

Conditions

High Risk of Stroke

Treatments

Behavioral: ORIENT diet intervention

Behavioral: Usual Diet advice

Study type

Interventional

Funder types

Other

Identifiers

NCT06098235

ENDS

Details and patient eligibility

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.

Full description

Oriental Intervention for Enhanced Neurocognitive Health (ORIENT) Diet in Populations with High Risk of Stroke is designed to test the impact of a 6-month intervention utilizing a culturally adapted version of the MIND diet, named as the ORIENT diet, on 160 participants (aged 40 years and above, and without dementia) with high risk of stroke (defined as having transient ischemic attack or having ≥ 3 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). The ORIENT diet retains the core components of the DASH, Mediterranean, and MIND diets, but incorporates adjustments according to evidence derived from Asian prospective cohorts and Chinese dietary practices. Participants in the intervention group will receive the ORIENT diet intervention, while participants in the control group will receive standard low-sodium and low-fat dietary advice. The study's primary objective is to assess the impact of the ORIENT diet on the brain functional networks of individual with high risk of stroke. The investigation will explore potential mediators and modifiers of the intervention's effects by collecting various cardiovascular risk factors, serum samples, fecal samples, neuropsychological assessment results, and multi-modal magnetic resonance imaging at baseline, 6 months, and 2 years.

Enrollment

160 estimated patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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