Oriental Intervention for Enhanced Neurocognitive Health (Orient) Diet in Populations With High Risk of Stroke (ENDS): a Randomized Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This randomized controlled trial will enroll 160 individuals aged over 40 without dementia who are at high risk of stroke, collecting multi-modal MRI imaging, serum, and fecal samples to investigate the impact of the ORIENT diet on brain functional networks.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:
• Patients aged ≥ 40 years
• High risk of stroke (with ≥ 3 of 8 stroke risk factors, including hypertension, dyslipidemia, diabetes, atrial fibrillation or valvular heart disease, smoking history, obvious overweight or obesity, lack of exercise, family history of stroke, or with transient ischemic attack)
• 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: 2023-11-01
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 160
Treatments
Placebo_comparator: Usual diet advice
Active_comparator: ORIENT diet intervention
Related Therapeutic Areas
Sponsors
Leads: Second Affiliated Hospital, School of Medicine, Zhejiang University