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

NCT05922137 | Recruiting

• 1 other identifier: ORIENT-ICS
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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 older than 40 years and without dementia.

Conditions

Cognitive Decline; Cognitive Change; Stenosis; Dementia

Keywords

Cognitive decline

Outcome Measures

Primary Outcomes (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

  6 months

Secondary Outcomes (13)

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

  6 months

• Cognitive function change assessed by Montreal Cognitive Assessment (minimum value = 0, maximum value = 30, and higher scores mean a better 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

  6 months

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

  6 months

• Changes in cerebral glymphatic function assessed by non-invasive diffusion tensor image analysis along the perivascular space (ALPS-index)

  6 months

Study Arms (2)

Usual Diet advice

PLACEBO COMPARATOR

Usual diet advice + standard medical treatment

Behavioral: Usual Diet advice

ORIENT diet intervention

ACTIVE COMPARATOR

6 month intervention of ORIENT diet + standard medical treatment

Behavioral: Oriental Intervention for Enhanced Neurocognitive Health (ORIENT) diet

Interventions

Usual Diet advice BEHAVIORAL

The usual diet advice include recommendations in guidelines, such as reducing salt and limiting alcohol consumption

Usual Diet advice

Oriental Intervention for Enhanced Neurocognitive Health (ORIENT) diet BEHAVIORAL

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.

ORIENT diet intervention

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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

Sponsors & Collaborators

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

Study Sites (1)

Second Affilated Hospital of Zhejiang University, School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction; Constriction, Pathologic; Dementia

Interventions

Diet

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Min Lou, PhD, MD

CONTACT

13958007213; lm99@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2023
• First Posted: June 28, 2023
• Study Start: May 1, 2023
• Primary Completion: May 21, 2023
• Study Completion (Estimated): May 31, 2027
• Last Updated: June 15, 2025

Record last verified: 2024-09

Locations

CN (1)