High Risk of StrokeNCT06098235
Oriental Intervention for Enhanced Neurocognitive Health (Orient) Diet in Populations With High Risk of Stroke (ENDS)
A study testing Usual Diet advice and ORIENT diet intervention in people with High Risk of Stroke, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- High Risk of Stroke
- What is being tested?
- Usual Diet advice and ORIENT diet intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2023to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Second Affilated Hospital of Zhejiang University, School of Medicine
Hangzhou, Zhejiang, 310009
Min Lou, PhD, MD, 13958007213, lm99@zju.edu.cn
About this study
Official title: 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.
Read the 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
- Being tested
- Usual Diet advice, ORIENT diet intervention
- Keywords
- stroke, Brain functional network connectivity
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual Diet adviceBehavioural
The usual diet advice include recommendations in guidelines, such as reducing salt and fat intake.
ORIENT diet interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual diet advice | Placebo comparator | Not described Receives: Behavioral: Usual Diet advice |
| ORIENT diet intervention | Active comparator | Not described Receives: Behavioral: ORIENT diet intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in brain functional network connectivity assessed by resting state functional magnetic resonance imaging (fMRI)
Primary Outcome
Measured: 6 months
Secondary outcomes (48)
Changes in brain functional network efficiency assessed by resting state fMRI
long-term secondary outcome
Measured: 2 years
Changes in brain functional network activity intensity assessed by resting state fMRI
long-term secondary outcome
Measured: 2 years
Changes in brain functional network efficiency assessed by resting state fMRI
long-term secondary outcome
Measured: 5 years
Changes in brain functional network activity intensity assessed by resting state fMRI
long-term secondary outcome
Measured: 5 years
Changes in brain functional network efficiency assessed by resting state fMRI
short-term secondary outcome
Measured: 6 months
Changes in brain functional network activity intensity assessed by resting state fMRI
short-term secondary outcome
Measured: 6 months
Changes in brain functional network connectivity assessed by resting state fMRI
long-term secondary outcome
Measured: 2 years
Changes in brain functional network connectivity assessed by resting state fMRI
long-term secondary outcome
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 5 years
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
Measured: 6 months
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
Measured: 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
Measured: 5 years
Changes in white matter hyperintensity (WMH) assessed on MRI with T2-Fluid-Attenuated-Inversion-Recovery (FLAIR) sequence
short-term secondary outcome
Measured: 6 months
Changes in lacunes assessed on MRI with T2 FLAIR sequence
short-term secondary outcome
Measured: 6 months
Changes in perivascular spaces assessed on MRI with T2 FLAIR sequence
short-term secondary outcome
Measured: 6 months
Changes in microbleeds assessed on MRI with Susceptibility Weighted Imaging (SWI) sequence sequence
short-term secondary outcome
Measured: 6 months
Changes in brain atrophy (width of the sulci greater than 5mm) assessed on MRI
short-term secondary outcome
Measured: 6 months
Changes in white matter hyperintensity (WMH) assessed on MRI with T2 FLAIR sequence
long-term secondary outcome
Measured: 2 years
Changes in white matter hyperintensity (WMH) assessed on MRI with T2 FLAIR sequence
long-term secondary outcome
Measured: 5 years
Changes in lacunes assessed on MRI with T2 FLAIR sequence
long-term secondary outcome
Measured: 2 years
Changes in lacunes assessed on MRI with T2 FLAIR sequence
long-term secondary outcome
Measured: 5 years
Changes in perivascular spaces assessed on MRI with T2 FLAIR sequence
long-term secondary outcome
Measured: 2 years
Changes in perivascular spaces assessed on MRI with T2 FLAIR sequence
long-term secondary outcome
Measured: 5 years
Changes in microbleeds assessed on MRI with SWI sequence sequence
long-term secondary outcome
Measured: 2 years
Changes in microbleeds assessed on MRI with SWI sequence sequence
long-term secondary outcome
Measured: 5 years
Changes in brain atrophy (width of the sulci greater than 5mm) assessed on MRI
long-term secondary outcome
Measured: 2 years
Changes in brain atrophy (width of the sulci greater than 5mm) assessed on MRI
long-term secondary outcome
Measured: 5 years
Changes in cerebral glymphatic function assessed by non-invasive diffusion tensor image analysis along the perivascular space (ALPS-index)
short-term secondary outcome
Measured: 6 months
Changes in cerebral glymphatic function assessed by non-invasive diffusion tensor image analysis along the perivascular space (ALPS-index)
long-term secondary outcome
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 2 years
Incidence of stroke event including ischemic and hemorrhagic stroke
short-term secondary outcome
Measured: 6 months
Incidence of stroke event including ischemic and hemorrhagic stroke
long-term secondary outcome
Measured: 2 years
Incidence of stroke event including ischemic and hemorrhagic stroke
long-term secondary outcome
Measured: 5 years
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
Measured: 6 months
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start1 Nov 2023
- Primary completion1 Nov 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Risk of StrokeStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06098235
- Sponsor's protocol ID
- ENDS
- Status last verified
- Apr 2025
- First submitted
- 11 Sep 2023
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oriental Intervention for Enhanced Neurocognitive Health (Orient) Diet in Populations With High Risk of Stroke (ENDS): a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06098235
- Acronym / sponsor ID
- ENDS
- Conditions
- High Risk of Stroke
- Keywords
- stroke, Brain functional network connectivity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 24 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual diet advice | Placebo comparator | Behavioral: Usual Diet advice |
| ORIENT diet intervention | Active comparator | Behavioral: ORIENT diet intervention |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual Diet adviceThe usual diet advice include recommendations in guidelines, such as reducing salt and fat intake. | Behavioural | Usual diet advice |
| ORIENT diet interventionThe 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. | Behavioural | ORIENT diet intervention |
Primary outcome
Changes in brain functional network connectivity assessed by resting state functional magnetic resonance imaging (fMRI)
Time frame: 6 months
Primary Outcome
48 secondary outcomes
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
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: 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)
Time frame: 5 years
Cognitive function change assessed with Mini-Mental State Examination (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)
Time frame: 6 months
Cognitive function change assessed with Mini-Mental State Examination (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)
Time frame: 2 years
Cognitive function change assessed with Mini-Mental State Examination (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)
Time frame: 5 years
Cognitive function change assessed by Montreal Cognitive Assessment (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)
Time frame: 6 months
Cognitive function change assessed by Montreal Cognitive Assessment (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)
Time frame: 2 years
Cognitive function change assessed by Montreal Cognitive Assessment (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)
Time frame: 5 years
Changes in white matter hyperintensity (WMH) assessed on MRI with T2-Fluid-Attenuated-Inversion-Recovery (FLAIR) sequence
Time frame: 6 months
Changes in lacunes assessed on MRI with T2 FLAIR sequence
Time frame: 6 months
Changes in perivascular spaces assessed on MRI with T2 FLAIR sequence
Time frame: 6 months
Changes in microbleeds assessed on MRI with Susceptibility Weighted Imaging (SWI) sequence sequence
Time frame: 6 months
Changes in brain atrophy (width of the sulci greater than 5mm) assessed on MRI
Time frame: 6 months
Changes in white matter hyperintensity (WMH) assessed on MRI with T2 FLAIR sequence
Time frame: 2 years
Changes in white matter hyperintensity (WMH) assessed on MRI with T2 FLAIR sequence
Time frame: 5 years
Changes in lacunes assessed on MRI with T2 FLAIR sequence
Time frame: 2 years
Changes in lacunes assessed on MRI with T2 FLAIR sequence
Time frame: 5 years
Changes in perivascular spaces assessed on MRI with T2 FLAIR sequence
Time frame: 2 years
Changes in perivascular spaces assessed on MRI with T2 FLAIR sequence
Time frame: 5 years
Changes in microbleeds assessed on MRI with SWI sequence sequence
Time frame: 2 years
Changes in microbleeds assessed on MRI with SWI sequence sequence
Time frame: 5 years
Changes in brain atrophy (width of the sulci greater than 5mm) assessed on MRI
Time frame: 2 years
Changes in brain atrophy (width of the sulci greater than 5mm) assessed on MRI
Time frame: 5 years
Changes in cerebral glymphatic function assessed by non-invasive diffusion tensor image analysis along the perivascular space (ALPS-index)
Time frame: 6 months
Changes in cerebral glymphatic function assessed by non-invasive diffusion tensor image analysis along the perivascular space (ALPS-index)
Time frame: 2 years
Changes in cerebral glymphatic function assessed by non-invasive diffusion tensor image analysis along the perivascular space (ALPS-index)
Time frame: 5 years
Changes in cerebral blood flow (CBF) in the territory of the culprit artery assessed by arterial spin labeling (ASL) perfusion image
Time frame: 6 months
Changes in cerebral blood flow (CBF) in the territory of the culprit artery assessed by arterial spin labeling (ASL) perfusion image
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Usual Diet advice and ORIENT diet intervention in people with High Risk of Stroke, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Min Lou, PhD, MD (13958007213, lm99@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in brain functional network connectivity assessed by resting state functional magnetic resonance imaging (fMRI) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.