NCT05922137 Oriental Intervention for Enhanced Neurocognitive Health (ORIENT) Diet in Patients With Intracranial / Carotid Stenosis
| NCT ID | NCT05922137 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Second Affiliated Hospital, Zhejiang University, School of Medicine |
| Condition | Cognitive Decline |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2023-05-01 |
| Primary Completion | 2023-05-21 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2023-05-01 with a primary completion date of 2023-05-21.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To test the effects of 6 month additional intervention of ORIENT diet versus usual medical treatment for Intracranial / Carotid Stenosis on cognitive decline, multi-mode MRI image markers and serum and fecal biomarkers in a randomized controlled trial of 120 patients with intracranial / carotid stenosis, who are aged older than 40 years and without dementia.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05922137 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Cognitive Decline. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05922137 currently recruiting?
Yes, NCT05922137 is actively recruiting participants. Contact the research team at lm99@zju.edu.cn for enrollment information.
Where is the NCT05922137 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT05922137 clinical trial?
NCT05922137 is sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine. The trial plans to enroll 120 participants.