Clinical trial NCT06098235: Oriental Intervention for Enhanced Neurocognitive Health (Orient) Diet in Populations With High Risk of Stroke (ENDS)
Official title: Oriental Intervention for Enhanced Neurocognitive Health (Orient) Diet in Populations With High Risk of Stroke (ENDS): a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: High Risk of Stroke
Keywords: stroke
Brain functional network connectivity
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2023-10-24
Enrollment: 160
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in brain functional network connectivity assessed by resting state functional magnetic resonance imaging (fMRI)
timeFrame: 6 months
Secondary outcomes:
measure: Changes in brain functional network efficiency assessed by resting state fMRI
timeFrame: 2 years
measure: Changes in brain functional network activity intensity assessed by resting state fMRI
timeFrame: 2 years
measure: Changes in brain functional network efficiency assessed by resting state fMRI
timeFrame: 5 years
measure: Changes in brain functional network activity intensity assessed by resting state fMRI
timeFrame: 5 years
measure: Changes in brain functional network efficiency assessed by resting state fMRI
timeFrame: 6 months
measure: Changes in brain functional network activity intensity assessed by resting state fMRI
timeFrame: 6 months
measure: Changes in brain functional network connectivity assessed by resting state fMRI
timeFrame: 2 years
measure: Changes in brain functional network connectivity assessed by resting state fMRI
timeFrame: 5 years
measure: 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)
timeFrame: 6 months
measure: 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)
timeFrame: 2 years
measure: 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)
timeFrame: 5 years
measure: 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)
timeFrame: 6 months
measure: 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)
timeFrame: 2 years
measure: 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)
timeFrame: 5 years
measure: Cognitive function change assessed with Mini-Mental State Examination (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)
timeFrame: 6 months
measure: Cognitive function change assessed with Mini-Mental State Examination (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)
timeFrame: 2 years
measure: Cognitive function change assessed with Mini-Mental State Examination (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)
timeFrame: 5 years
measure: Cognitive function change assessed by Montreal Cognitive Assessment (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)
timeFrame: 6 months
measure: Cognitive function change assessed by Montreal Cognitive Assessment (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)
timeFrame: 2 years
measure: Cognitive function change assessed by Montreal Cognitive Assessment (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)
timeFrame: 5 years
measure: Changes in white matter hyperintensity (WMH) assessed on MRI with T2-Fluid-Attenuated-Inversion-Recovery (FLAIR) sequence
timeFrame: 6 months
measure: Changes in lacunes assessed on MRI with T2 FLAIR sequence
timeFrame: 6 months
measure: Changes in perivascular spaces assessed on MRI with T2 FLAIR sequence
timeFrame: 6 months
measure: Changes in microbleeds assessed on MRI with Susceptibility Weighted Imaging (SWI) sequence sequence
timeFrame: 6 months
measure: Changes in brain atrophy (width of the sulci greater than 5mm) assessed on MRI
timeFrame: 6 months
measure: Changes in white matter hyperintensity (WMH) assessed on MRI with T2 FLAIR sequence
timeFrame: 2 years
measure: Changes in white matter hyperintensity (WMH) assessed on MRI with T2 FLAIR sequence
timeFrame: 5 years
measure: Changes in lacunes assessed on MRI with T2 FLAIR sequence
timeFrame: 2 years
measure: Changes in lacunes assessed on MRI with T2 FLAIR sequence
timeFrame: 5 years
measure: Changes in perivascular spaces assessed on MRI with T2 FLAIR sequence
timeFrame: 2 years
measure: Changes in perivascular spaces assessed on MRI with T2 FLAIR sequence
timeFrame: 5 years
measure: Changes in microbleeds assessed on MRI with SWI sequence sequence
timeFrame: 2 years
measure: Changes in microbleeds assessed on MRI with SWI sequence sequence
timeFrame: 5 years
measure: Changes in brain atrophy (width of the sulci greater than 5mm) assessed on MRI
timeFrame: 2 years
measure: Changes in brain atrophy (width of the sulci greater than 5mm) assessed on MRI
timeFrame: 5 years
measure: Changes in cerebral glymphatic function assessed by non-invasive diffusion tensor image analysis along the perivascular space (ALPS-index)
timeFrame: 6 months
measure: Changes in cerebral glymphatic function assessed by non-invasive diffusion tensor image analysis along the perivascular space (ALPS-index)
timeFrame: 2 years
measure: Changes in cerebral glymphatic function assessed by non-invasive diffusion tensor image analysis along the perivascular space (ALPS-index)
timeFrame: 5 years
measure: Changes in cerebral blood flow (CBF) in the territory of the culprit artery assessed by arterial spin labeling (ASL) perfusion image
timeFrame: 6 months
measure: Changes in cerebral blood flow (CBF) in the territory of the culprit artery assessed by arterial spin labeling (ASL) perfusion image
timeFrame: 2 years
measure: Changes in cerebral blood flow (CBF) in the territory of the culprit artery assessed by arterial spin labeling (ASL) perfusion image
timeFrame: 5 years
measure: Metabolite profiles in participants' faecal samples and serum samples
timeFrame: 6 months
measure: Metabolite profiles in participants' faecal samples and serum samples
timeFrame: 2 years
measure: Incidence of stroke event including ischemic and hemorrhagic stroke
timeFrame: 6 months
measure: Incidence of stroke event including ischemic and hemorrhagic stroke
timeFrame: 2 years
measure: Incidence of stroke event including ischemic and hemorrhagic stroke
timeFrame: 5 years
measure: 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)
timeFrame: 6 months
measure: 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)
timeFrame: 6 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affilated Hospital of Zhejiang University, School of Medicine
state: Zhejiang
Study officials:
References: