Diet intervention to improve cognitive health in patients with carotid stenosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.