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Clinical Trials in China / NCT05922137
Recruiting Not applicable

Oriental Intervention for Enhanced Neurocognitive Health (ORIENT) Diet in Patients With Intracranial / Carotid Stenosis

NCT05922137 · tracked via the Priya Life Science China tracker
Sponsor
Second Affiliated Hospital, Zhejiang University, School of Medicine
Phase
Not applicable
Started
2023-05-01
Last updated
2025-06-15

Condition(s) studied

Cognitive DeclineCognitive ChangeStenosisDementia

Investigational drug(s) / intervention(s)

Usual Diet adviceOriental Intervention for Enhanced Neurocognitive Health (ORIENT) diet

Usual Diet advice: The usual diet advice include recommendations in guidelines, such as reducing salt and limiting alcohol consumption

Oriental Intervention for Enhanced Neurocognitive Health (ORIENT) diet: The ORIENT diet has the same basic components of the Dietary Approaches to Stop Hypertension (DASH), Mediterranean and MIND diets, but uniquely adjusting some of components according to the evidence derived from Asian prospective cohorts and the Chinese eating habits.

Study 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

Sex
ALL
Min age
40 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Global cognitive function change assessed with Z-score of a modified National Institute of Neurological Disorders and Stroke and Canadian Stroke Network-Canadian Stroke Network (NINDS-CSN) protocol — 6 months
    Primary Outcome

Trial sites (1)

FacilityCityRegionStatus
Second Affilated Hospital of Zhejiang University, School of Medicine Hangzhou Zhejiang Recruiting

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Other trials for the same condition

Fuzhou Aging Brain Health Initiative Recruiting
A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5) Active, not recruiting
Biomarker-Integrated Digital Guidance for Early Alzheimer's Detection (BRIDGE-AD): A Nationwide Multicenter Study Recruiting
Efficacy Biomarkers of DAOIB for Dementia Recruiting
Clinical Registration Study of Patients With Intracranial / Carotid Stenosis Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05922137 on ClinicalTrials.gov ↗ ← All trials in China