Health TrialsbyHealthPanel

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

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

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

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 limiting alcohol consumption

  • 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.

Treatment groups

120 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

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

Time frame
6 months

Secondary outcomes

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

Time frame
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

Time frame
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

Time frame
6 months
4

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

short-term secondary outcome

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Second Affiliated Hospital, School of Medicine, Zhejiang University

Lead sponsor

Source ClinicalTrials.gov
Apply now