Oriental Intervention for Enhanced Neurocognitive Health (Orient) Diet in Populations With High Risk of Stroke (ENDS): a Randomized Controlled Trial
Usual Diet advice
+ ORIENT diet intervention
Brain Diseases+4
+ Cardiovascular Diseases
+ Central Nervous System Diseases
Prevention Study
Summary
Study start date: November 1, 2023
Actual date on which the first participant was enrolled.This study is investigating how a specific diet, called the ORIENT diet, affects people who have a high risk of stroke. It focuses on individuals aged 40 and above who have certain health conditions or lifestyle factors that increase their stroke risk, such as high blood pressure, diabetes, or a family history of stroke. The ORIENT diet is a version of the MIND diet adapted to include Asian dietary practices. The goal is to see if following this diet for six months can improve brain health and reduce stroke risk, which is important as strokes can lead to serious health issues. Participants in this study are divided into two groups. One group follows the ORIENT diet, while the other receives advice to eat less salt and fat, which is the standard recommendation. Researchers assess the diet's impact by looking at brain function, collecting blood and stool samples, and performing various health assessments at the start, after six months, and again after two years. The study will use these evaluations to determine if the diet can positively influence brain health and reduce factors that contribute to stroke risk.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.160 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 40 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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: * 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
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
PlaceboGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Second Affilated Hospital of Zhejiang University, School of Medicine
Hangzhou, ChinaOpen Second Affilated Hospital of Zhejiang University, School of Medicine in Google Maps