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

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.

Study Overview

• Status: Recruiting
• Conditions: Dementia; Cognitive Change; Cognitive Decline; Stenosis
• Intervention / Treatment: Behavioral: Usual Diet advice; Behavioral: Oriental Intervention for Enhanced Neurocognitive Health (ORIENT) diet

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• 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
      • Principal Investigator: Changzheng Yuan, ScD

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• 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

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; Usual diet advice + standard medical treatment	Behavioral: Usual Diet advice; The usual diet advice include recommendations in guidelines, such as reducing salt and limiting alcohol consumption
Active Comparator: ORIENT diet intervention; 6 month intervention of ORIENT diet + standard medical treatment	Behavioral: Oriental Intervention for Enhanced Neurocognitive Health (ORIENT) diet; 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
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	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	6 months
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)	2 years
Gut microbiota determined by measuring specific bacterial levels in the fecal samples	short-term secondary outcome	6 months
Gut microbiota determined by measuring specific bacterial levels in the fecal samples	long-term secondary outcome	2 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	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	6 months
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	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 white matter hyperintensity (WMH) assessed on MRI with T2-Fluid-Attenuated-Inversion-Recovery (FLAIR) sequence	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	short-term secondary outcome	6 months
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	6 months
Incidence of stroke event including ischemic and hemorrhagic stroke		6 months and 2 years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Actual): May 21, 2023
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: May 7, 2023
• First Submitted That Met QC Criteria: June 18, 2023
• First Posted (Actual): June 28, 2023

Study Record Updates

• Last Update Posted (Actual): June 15, 2025
• Last Update Submitted That Met QC Criteria: June 11, 2025
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Cognitive decline
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Mental Disorders; Pathological Conditions, Anatomical; Neurocognitive Disorders; Cognition Disorders; Arterial Occlusive Diseases; Carotid Artery Diseases; Cognitive Dysfunction; Constriction, Pathologic; Carotid Stenosis
• Other Study ID Numbers: ORIENT-ICS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No