Diet intervention to improve cognitive health in patients with carotid stenosis
Oriental Intervention for Enhanced Neurocognitive Health (ORIENT) Diet in Patients With Intracranial / Carotid Stenosis : a Randomized Controlled Trial
This study is testing whether following a special diet for six months can help improve brain health in people aged 40 and older with narrowed arteries in the neck.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (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 | NCT05922137 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of a 6-month intervention using the ORIENT diet, a culturally adapted version of the MIND diet, on cognitive decline in patients aged 40 and older with intracranial or carotid stenosis. A total of 120 participants will be randomized to receive either the ORIENT diet alongside standard medical treatment or usual dietary advice with standard treatment. The study aims to assess cognitive function and brain integrity through neuropsychological assessments and multi-modal MRI imaging at 6-month intervals. The research will also explore various cardiovascular risk factors that may influence the intervention's effects.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 40 years and older with at least 50% stenosis in a unilateral intracranial or carotid artery and without dementia.
Not a fit: Patients with a history of major head trauma, intracranial surgery, or severe sensory impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could enhance cognitive health and slow cognitive decline in patients with carotid stenosis.
How similar studies have performed: While the specific ORIENT diet approach is novel, similar dietary interventions have shown promise in improving cognitive health in other populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged ≥ 40 years * ≥ 50% stenosis in unilateral intracranial / carotid artery * 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: * 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 * Nuts, berries, olive oil, or fish allergies * Patients presenting a malignant disease with life expectancy \< 3 years * Participation in an ongoing investigational drug study 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.