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

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.

Study Overview

• Status: Recruiting
• Conditions: High Risk of Stroke
• Intervention / Treatment: Behavioral: Usual Diet advice; Behavioral: ORIENT diet intervention

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.

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Min Lou, PhD, MD; Phone Number: 13958007213; Email: lm99@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • Second Affilated Hospital of Zhejiang University, School of Medicine
      • Contact: Min Lou, PhD, MD; Phone Number: 13958007213; Email: lm99@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Nuts, berries, olive oil, or fish allergies
• previously diagnosed dementia
• Suspected dementia after clinical assessment by study physician at screening visit
• 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
• Patients presenting a malignant disease with life expectancy < 3 years
• Participation in an ongoing investigational drug study
• Any MRI contraindications

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Usual diet advice	Behavioral: Usual Diet advice; The usual diet advice include recommendations in guidelines, such as reducing salt and fat intake.
Active Comparator: ORIENT diet intervention	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in brain functional network connectivity assessed by resting state functional magnetic resonance imaging (fMRI)	Primary Outcome	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Oriental Intervention for Enhanced Neurocognitive Health (ORIENT) diet scale (minimum value = 0, maximum value = 14, and higher scores mean a better outcome)	short-term secondary outcome	6 months
Cognitive function change assessed by Montreal Cognitive Assessment (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)	short-term secondary outcome	6 months
Changes in cerebral glymphatic function assessed by non-invasive diffusion tensor image analysis along the perivascular space (ALPS-index)	short-term secondary outcome	6 months
Changes in brain functional network efficiency assessed by resting state fMRI	long-term secondary outcome	2 years
Changes in brain functional network activity intensity assessed by resting state fMRI	long-term secondary outcome	2 years
Changes in brain functional network efficiency assessed by resting state fMRI	long-term secondary outcome	5 years
Changes in brain functional network activity intensity assessed by resting state fMRI	long-term secondary outcome	5 years
Changes in brain functional network efficiency assessed by resting state fMRI	short-term secondary outcome	6 months
Changes in brain functional network activity intensity assessed by resting state fMRI	short-term secondary outcome	6 months
Changes in brain functional network connectivity assessed by resting state fMRI	long-term secondary outcome	2 years
Changes in brain functional network connectivity assessed by resting state fMRI	long-term secondary outcome	5 years
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 (higher scores mean a better outcome)	short-term secondary outcome	6 months
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 (higher scores mean a better outcome)	long-term secondary outcome	2 years
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 (higher scores mean a better outcome)	long-term secondary outcome	5 years
Cognitive domain 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 (higher scores mean a better outcome)	short-term secondary outcome	6 months
Cognitive domain 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 (higher scores mean a better outcome)	long-term secondary outcome	2 years
Cognitive domain 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 (higher scores mean a better outcome)	long-term secondary outcome	5 years
Cognitive function change assessed with Mini-Mental State Examination (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)	short-term secondary outcome	6 months
Cognitive function change assessed with Mini-Mental State Examination (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)	long-term secondary outcome	2 years
Cognitive function change assessed with Mini-Mental State Examination (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)	long-term secondary outcome	5 years
Cognitive function change assessed by Montreal Cognitive Assessment (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)	long-term secondary outcome	2 years
Cognitive function change assessed by Montreal Cognitive Assessment (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)	long-term secondary outcome	5 years
Changes in white matter hyperintensity (WMH) assessed on MRI with T2-Fluid-Attenuated-Inversion-Recovery (FLAIR) sequence	short-term secondary outcome	6 months
Changes in lacunes assessed on MRI with T2 FLAIR sequence	short-term secondary outcome	6 months
Changes in perivascular spaces assessed on MRI with T2 FLAIR sequence	short-term secondary outcome	6 months
Changes in microbleeds assessed on MRI with Susceptibility Weighted Imaging (SWI) sequence sequence	short-term secondary outcome	6 months
Changes in brain atrophy (width of the sulci greater than 5mm) assessed on MRI	short-term secondary outcome	6 months
Changes in white matter hyperintensity (WMH) assessed on MRI with T2 FLAIR sequence	long-term secondary outcome	2 years
Changes in white matter hyperintensity (WMH) assessed on MRI with T2 FLAIR sequence	long-term secondary outcome	5 years
Changes in lacunes assessed on MRI with T2 FLAIR sequence	long-term secondary outcome	2 years
Changes in lacunes assessed on MRI with T2 FLAIR sequence	long-term secondary outcome	5 years
Changes in perivascular spaces assessed on MRI with T2 FLAIR sequence	long-term secondary outcome	2 years
Changes in perivascular spaces assessed on MRI with T2 FLAIR sequence	long-term secondary outcome	5 years
Changes in microbleeds assessed on MRI with SWI sequence sequence	long-term secondary outcome	2 years
Changes in microbleeds assessed on MRI with SWI sequence sequence	long-term secondary outcome	5 years
Changes in brain atrophy (width of the sulci greater than 5mm) assessed on MRI	long-term secondary outcome	2 years
Changes in brain atrophy (width of the sulci greater than 5mm) assessed on MRI	long-term secondary outcome	5 years
Changes in cerebral glymphatic function assessed by non-invasive diffusion tensor image analysis along the perivascular space (ALPS-index)	long-term secondary outcome	2 years
Changes in cerebral glymphatic function assessed by non-invasive diffusion tensor image analysis along the perivascular space (ALPS-index)	long-term secondary outcome	5 years
Changes in cerebral blood flow (CBF) in the territory of the culprit artery assessed by arterial spin labeling (ASL) perfusion image	short-term secondary outcome	6 months
Changes in cerebral blood flow (CBF) in the territory of the culprit artery assessed by arterial spin labeling (ASL) perfusion image	long-term secondary outcome	2 years
Changes in cerebral blood flow (CBF) in the territory of the culprit artery assessed by arterial spin labeling (ASL) perfusion image	long-term secondary outcome	5 years
Metabolite profiles in participants' faecal samples and serum samples	short-term secondary outcome: metabolite composition was analyzed via liquid chromatography tandem mass spectrometry (LC-MS/MS)	6 months
Metabolite profiles in participants' faecal samples and serum samples	long-term secondary outcome: metabolite composition was analyzed via liquid chromatography tandem mass spectrometry (LC-MS/MS)	2 years
Incidence of stroke event including ischemic and hemorrhagic stroke	short-term secondary outcome	6 months
Incidence of stroke event including ischemic and hemorrhagic stroke	long-term secondary outcome	2 years
Incidence of stroke event including ischemic and hemorrhagic stroke	long-term secondary outcome	5 years
Change in the Mediterranean-DASH Diet Intervention for Neurodegenerative Delay (MIND) diet scale (minimum value = 0, maximum value = 15, and higher scores mean a better outcome)	short-term secondary outcome	6 months

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: September 11, 2023
• First Submitted That Met QC Criteria: October 19, 2023
• First Posted (Actual): October 24, 2023

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: stroke; Brain functional network connectivity
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: ENDS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No