Diet intervention to improve brain health in stroke-prone individuals
Oriental Intervention for Enhanced Neurocognitive Health (Orient) Diet in Populations With High Risk of Stroke (ENDS): a Randomized Controlled Trial
This study is testing whether a special diet can help improve brain health in people over 40 who are at high risk of having a stroke.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06098235 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial aims to enroll 160 individuals over the age of 40 who are at high risk of stroke. Participants will be assigned to either an intervention group receiving a culturally adapted ORIENT diet or a control group receiving standard dietary advice. The study will collect multi-modal MRI imaging, serum, and fecal samples to assess the impact of the ORIENT diet on brain functional networks over a period of 6 months. The research will also explore various cardiovascular risk factors and neuropsychological assessments to understand the diet's effects on cognitive health.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 40 and older who are at high risk of stroke due to multiple risk factors.
Not a fit: Patients with a history of dementia or significant neurological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could enhance neurocognitive health and reduce stroke risk in high-risk populations.
How similar studies have performed: Other studies have shown positive outcomes with dietary interventions aimed at improving cognitive health, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Hangzhou, Zhejiang
- Second Affilated Hospital of Zhejiang University, School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Min Lou, PhD, MD
- Email: lm99@zju.edu.cn
- Phone: 13958007213
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.