NCT06098235

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
1mo left

Started Nov 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress95%
Nov 2023Jun 2026

First Submitted

Initial submission to the registry

September 11, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 24, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

June 15, 2025

Status Verified

April 1, 2025

Enrollment Period

2 years

First QC Date

September 11, 2023

Last Update Submit

June 11, 2025

Conditions

High Risk of Stroke

Keywords

strokeBrain functional network connectivity

Outcome Measures

Primary Outcomes (1)

  • Changes in brain functional network connectivity assessed by resting state functional magnetic resonance imaging (fMRI)

    Primary Outcome

    6 months

Secondary Outcomes (48)

  • Changes in brain functional network efficiency assessed by resting state fMRI

    2 years

  • Changes in brain functional network activity intensity assessed by resting state fMRI

    2 years

  • Changes in brain functional network efficiency assessed by resting state fMRI

    5 years

  • Changes in brain functional network activity intensity assessed by resting state fMRI

    5 years

  • Changes in brain functional network efficiency assessed by resting state fMRI

    6 months

  • +43 more secondary outcomes

Study Arms (2)

Usual diet advice

PLACEBO COMPARATOR
Behavioral: Usual Diet advice

ORIENT diet intervention

ACTIVE COMPARATOR
Behavioral: ORIENT diet intervention

Interventions

Usual Diet adviceBEHAVIORAL

The usual diet advice include recommendations in guidelines, such as reducing salt and fat intake.

Usual diet advice
ORIENT diet interventionBEHAVIORAL

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

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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:
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Affilated Hospital of Zhejiang University, School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Min Lou, PhD, MD

CONTACT

13958007213lm99@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

September 11, 2023

First Posted

October 24, 2023

Study Start

November 1, 2023

Primary Completion

November 1, 2025

Study Completion (Estimated)

June 30, 2026

Last Updated

June 15, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)