Oriental Intervention for Enhanced Neurocognitive Health (Orient) Diet in Populations With High Risk of Stroke (ENDS)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Usual Diet advice

    Behavioral

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

  • ORIENT diet intervention

    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.

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: Usual diet advicePlacebo comparator 1 intervention
Group B: ORIENT diet interventionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Primary Outcome

Time frame
6 months

Secondary outcomes

1

Changes in brain functional network efficiency assessed by resting state fMRI

long-term secondary outcome

Time frame
2 years
2

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

long-term secondary outcome

Time frame
2 years
3

Changes in brain functional network efficiency assessed by resting state fMRI

long-term secondary outcome

Time frame
5 years
4

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

long-term secondary outcome

Time frame
5 years

Other outcomes

Sponsors and contacts

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