Oriental Intervention for Enhanced Neurocognitive Health (ORIENT) Diet in Patients With Intracranial / Carotid Stenosis : a Randomized Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
Second Affilated Hospital of Zhejiang University, School of Medicine
RECRUITING
Hangzhou
Contact Information
Primary
Min Lou, PhD, MD
lm99@zju.edu.cn
13958007213
Time Frame
Start Date: 2023-05-01
Estimated Completion Date: 2027-05-31
Participants
Target number of participants: 120
Treatments
Placebo_comparator: Usual Diet advice
Usual diet advice + standard medical treatment
Active_comparator: ORIENT diet intervention
6 month intervention of ORIENT diet + standard medical treatment
Related Therapeutic Areas
Sponsors
Leads: Second Affiliated Hospital, School of Medicine, Zhejiang University