Oriental Intervention for Enhanced Neurocognitive Health (Orient) Diet in Populations With High Risk of Stroke (ENDS)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Usual Diet advice, ORIENT diet intervention.
- Who it may be relevant to
- Registry conditions: High Risk of Stroke. Basic parameters: from 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Oriental Intervention for Enhanced Neurocognitive Health (Orient) Diet in Populations With High Risk of Stroke (ENDS): a Randomized Controlled Trial
Overview
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.
Interventions
- 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.
Primary outcome measures
- Changes in brain functional network connectivity assessed by resting state functional magnetic resonance imaging (fMRI) [Time frame: 6 months]
Secondary outcome measures (12)
- Changes in brain functional network efficiency assessed by resting state fMRI [Time frame: 2 years]
- Changes in brain functional network activity intensity assessed by resting state fMRI [Time frame: 2 years]
- Changes in brain functional network efficiency assessed by resting state fMRI [Time frame: 5 years]
- Changes in brain functional network activity intensity assessed by resting state fMRI [Time frame: 5 years]
- Changes in brain functional network efficiency assessed by resting state fMRI [Time frame: 6 months]
- Changes in brain functional network activity intensity assessed by resting state fMRI [Time frame: 6 months]
- Changes in brain functional network connectivity assessed by resting state fMRI [Time frame: 2 years]
- Changes in brain functional network connectivity assessed by resting state fMRI [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 6 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
China · 1 center
- Second Affilated Hospital of Zhejiang University, School of Medicine — Hangzhou
Identifiers
NCT: NCT06098235 · ENDS