NCT06098235

Oriental Intervention for Enhanced Neurocognitive Health (Orient) Diet in Populations With High Risk of Stroke (ENDS)

Oriental Intervention for Enhanced Neurocognitive Health (Orient) Diet in Populations With High Risk of Stroke (ENDS): a Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Oriental Intervention for Enhanced Neurocognitive Health (ORIENT) Diet in Populations with High Risk of Stroke is designed to test the impact of a 6-month intervention utilizing a culturally adapted version of the MIND diet, named as the ORIENT diet, on 160 participants (aged 40 years and above, and without dementia) with high risk of stroke (defined as having transient ischemic attack or having ≥ 3 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). The ORIENT diet retains the core components of the DASH, Mediterranean, and MIND diets, but incorporates adjustments according to evidence derived from Asian prospective cohorts and Chinese dietary practices. Participants in the intervention group will receive the ORIENT diet intervention, while participants in the control group will receive standard low-sodium and low-fat dietary advice. The study's primary objective is to assess the impact of the ORIENT diet on the brain functional networks of individual with high risk of stroke. The investigation will explore potential mediators and modifiers of the intervention's effects by collecting various cardiovascular risk factors, serum samples, fecal samples, neuropsychological assessment results, and multi-modal magnetic resonance imaging at baseline, 6 months, and 2 years.

Conditions

• High Risk of Stroke

Interventions

Type	Name	Description
BEHAVIORAL	Usual Diet advice	The usual diet advice include recommendations in guidelines, such as reducing salt and fat intake.
BEHAVIORAL	ORIENT diet intervention	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.

Timeline

• Start date: 2023-11-01
• Primary completion: 2025-11-01
• Completion: 2026-06-30
• First posted: 2023-10-24
• Last updated: 2025-06-15

Locations

1 site across 1 country: China