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Cognitive DeclineORIENTNCT05922137

Oriental Intervention for Enhanced Neurocognitive Health (ORIENT) Diet in Patients With Intracranial / Carotid Stenosis

A study testing Usual Diet advice and Oriental Intervention for Enhanced Neurocognitive Health (ORIENT) diet in people with Cognitive Decline and Cognitive Change, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

To test the effects of 6 month additional intervention of ORIENT diet versus usual medical treatment for Intracranial / Carotid Stenosis on cognitive decline, multi-mode MRI image markers and serum and fecal biomarkers in a randomized controlled trial of 120 patients with intracranial / carotid stenosis, who are aged… Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Cognitive Decline, Cognitive Change, Stenosis
What is being tested?
Usual Diet advice and Oriental Intervention for Enhanced Neurocognitive Health (ORIENT) diet
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteChina
Study dates
1 May 2023to 31 May 2027
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
  • ≥ 50% stenosis in unilateral intracranial / carotid artery
  • 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

  • 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
  • Nuts, berries, olive oil, or fish allergies
  • Patients presenting a malignant disease with life expectancy < 3 years
Show all 11Show fewer
  • Participation in an ongoing investigational drug study
  • 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.

Min Lou, PhD, MD contact

13958007213

lm99@zju.edu.cn

China1 site, 1 recruiting

  • Second Affilated Hospital of Zhejiang University, School of Medicine

    Hangzhou, Zhejiang, 310009

    Min Lou, PhD, MD, 13958007213, lm99@zju.edu.cn

    Changzheng Yuan, ScD

    Recruiting

Other trials in China

About this study

Official title: Oriental Intervention for Enhanced Neurocognitive Health (ORIENT) Diet in Patients With Intracranial / Carotid Stenosis : a Randomized Controlled Trial

To test the effects of 6 month additional intervention of ORIENT diet versus usual medical treatment for Intracranial / Carotid Stenosis on cognitive decline, multi-mode MRI image markers and serum and fecal biomarkers in a randomized controlled trial of 120 patients with intracranial / carotid stenosis, who are aged older than 40 years and without dementia.

Read the detailed description

Oriental Intervention for Enhanced Neurocognitive Health (ORIENT) diet in Patients With Intracranial / Carotid Stenosis 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 120 older patients (aged 40 years and above and without dementia) diagnosed with intracranial/carotid stenosis (defined as ≥ 50% stenosis in unilateral intracranial/carotid artery as detected by vascular imaging diagnostic techniques, such as magnetic resonance angiography). 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 standard medical treatment in conjunction with the ORIENT diet intervention, while those in the control group will undergo standard medical treatment and receive usual dietary advice. The study's primary objective is to assess the influence of the ORIENT diet on cognitive function and brain macro- and microstructural integrity in patients with intracranial/carotid stenosis. This will be achieved through the administration of neuropsychological assessments and multi-modal magnetic resonance imaging at 6-month intervals until the completion of the trial. The investigation will explore potential mediators and modifiers of the intervention's effects by examining various cardiovascular risk factors, serum and fecal biomarkers, and underlying biological mechanisms.

Being tested
Usual Diet advice, Oriental Intervention for Enhanced Neurocognitive Health (ORIENT) diet
Keywords
Cognitive decline
Medical subject headings
Cognitive Dysfunction, Constriction, Pathologic, Dementia

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 limiting alcohol consumption

  • Oriental Intervention for Enhanced Neurocognitive Health (ORIENT) dietBehavioural

    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 groups in NCT05922137
Study groupRoleWhat they receive
Usual Diet advicePlacebo comparatorUsual diet advice + standard medical treatment
Receives: Behavioral: Usual Diet advice
ORIENT diet interventionActive comparator6 month intervention of ORIENT diet + standard medical treatment
Receives: Behavioral: Oriental Intervention for Enhanced Neurocognitive Health (ORIENT) diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Primary Outcome

    Measured: 6 months

Secondary outcomes (13)

  1. Cognitive domain change assessed with NINDS-CSN protocol, including working memory, executive function, language, visual motor speed, visual spatial function, memory and recognition

    short-term secondary outcome

    Measured: 6 months

  2. 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

  3. Changes in functional network-related characteristics assessed by functional magnetic resonance imaging (fMRI), including intra- and inter-network connectivity, graph theory, and dynamic functional connectivity

    short-term secondary outcome

    Measured: 6 months

  4. Changes in white matter hyperintensity (WMH) assessed on MRI with T2-Fluid-Attenuated-Inversion-Recovery (FLAIR) sequence

    short-term secondary outcome

    Measured: 6 months

  5. 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

  6. 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

  7. Metabolite composition to measure the 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

  8. Metabolite composition to measure the 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

  9. Gut microbiota determined by measuring specific bacterial levels in the fecal samples

    short-term secondary outcome

    Measured: 6 months

  10. Gut microbiota determined by measuring specific bacterial levels in the fecal samples

    long-term secondary outcome

    Measured: 2 years

  11. Incidence of stroke event including ischemic and hemorrhagic stroke

    Measured: 6 months and 2 years

  12. 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

  13. 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.

  1. First posted28 Jun 2023
  2. Study start1 May 2023
  3. Primary completion21 May 2023
  4. Study completion31 May 2027 (estimated)

Resources

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
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05922137
Sponsor's protocol ID
ORIENT-ICS
Acronym
ORIENT
Status last verified
Sep 2024
First submitted
7 May 2023
Last updated
15 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Usual Diet advice and Oriental Intervention for Enhanced Neurocognitive Health (ORIENT) diet in people with Cognitive Decline and Cognitive Change, 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 11 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?

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 (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05922137.

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.

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