MIND Diet to Improve Cognitive Function in Mild Stroke Patients (MINDICOMS) II
- Conditions
- StrokeDementiaCerebrovascular; Disorder, ThromboticCognitive Change
- Interventions
- Behavioral: General dietary adviceBehavioral: Localized MIND diet interventionOther: Routine medical care
- Registration Number
- NCT06331247
- Lead Sponsor
- Zhejiang University
- Brief Summary
A 6-month pilot randomized controlled trial designed to test the effect of the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) Diet + usual medical care versus usual medical care on cognitive change and several other secondary outcomes through a randomized controlled trial in 60 mild stroke patients aged 35-70 years without dementia.
- Detailed Description
Mediterranean-DASH (Dietary Approach to Stop Hypertension) Intervention for Neurodegenerative Delay (MIND) Diet and Cognitive Decline in Mild Stroke Patients (MINDICOMS) II is a 6-month pilot randomized controlled trial designed to test the effects of the MIND diet on cognitive change and several other secondary outcomes among 60 individuals aged 35-70 years without dementia. The proposed MIND diet for this study is a hybrid of the Mediterranean and DASH diets but with selected modifications based on the most compelling evidence in the diet-dementia field and Chinese Dietary Guidelines 2022. Specifically, the proposed MIND diet will emphasize the consumption of whole grains, dark green leafy vegetables, dark red/yellow vegetables, other vegetables, berries and citrus, poultry, fish and seafood, beans and legume, nuts, olive and seed oils, and green tea, and restrict red and processed meats, animal fat, fried foods, and sweets and pastries. The trial will employ a parallel group design comparing the effects on global cognitive change of the MIND intervention diet to usual medical care among 60 mild stroke patients aged 35-70 years. Secondary outcomes will include cognitive function changes in several domains, brain imaging marker changes, dietary behaviour changes, daily living behaviour ability changes, mental health changes, and plasma biomarker changes. In addition, this trial will examine potential effect mediators and modifiers. The proposed study is sited at the Bo'Ao District, Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou. Specialized laboratories will conduct biochemical analyses.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- Clinically confirmed new cerebral infarction, onset hospitalization time ≤14 days
- National Institutes of Health Stroke Scale (NIHSS) score of 0-6, with no difficulty in autonomous eating or aphasia
- Baseline MMSE score being 16-25/30 points or MoCA score ≤24/30 points, with signs of post-stroke cognitive decline
- Baseline MIND dietary pattern screening scale score ≤10/15 points
- Body mass index no less than 18.0 kg/m2
- Normal chewing function, able to eat hard foods such as nuts
- Willing to participate and sign an informed consent form
- Agree not to take over-the-counter nutritional supplements during the trial period
- Able to understand research procedures and adhere to them throughout the entire study period
- Completed the run-in test
- Diagnosis of dementia at a county-level or above hospital before the stroke or suspected to have pre-stroke dementia from the informant interview administered by a neurologist.
- Participation in or have participated in other clinical trial studies within the past year
- Allergies to foods involved in the experiment (nuts, berries, olive oil, or fish, etc.) or using drugs not compatible with foods involved.
- Medication to treat Alzheimer's or Parkinson's disease
- Diagnosis of cancer, severe liver and kidney disease, or current life expectancy less than 6 months
- Diagnosis of depression, bipolar disorder, or other mental illnesses
- Pregnancy or breastfeeding or with a pregnancy plan
- Diagnosis of inflammatory bowel disease or other malabsorption-related gastrointestinal diseases
- History of alcohol or drug abuse
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control arm General dietary advice Usual medical care (including general dietary advice). MIND diet intervention arm Routine medical care Usual medical care (including general dietary advice) plus the MIND diet intervention. Control arm Routine medical care Usual medical care (including general dietary advice). MIND diet intervention arm General dietary advice Usual medical care (including general dietary advice) plus the MIND diet intervention. MIND diet intervention arm Localized MIND diet intervention Usual medical care (including general dietary advice) plus the MIND diet intervention.
- Primary Outcome Measures
Name Time Method Change in global cognitive function 6 months Global cognitive function assessment is based on a battery of 18 cognitive tests. Individual test scores will be summarized by calculating the z-score for each test based on the mean and standard deviation of the sample distribution - averaging z-scores across tests will yield a composite score for global cognitive function. Cognitive function will be assessed at the baseline, 3, and 6 months to determine cognitive change.
Change in MIND diet score 6 months Dietary behavior will be assessed using food frequency questionnaire (FFQ). A 15-point MIND diet score will be calculated to reflect the MIND diet adherence among both groups of participants.
- Secondary Outcome Measures
Name Time Method Change in Montreal Cognitive Assessment (MoCA) score 6 months MoCA will be administered at the baseline, 3, and 6 months to determine cognitive change.
Change in language function 6 months Change in language function will be assessed at the baseline, 3, and 6 months using the language domain tests from the neuropsychological test battery.
Change in executive function 6 months Change in executive function will be assessed at the baseline, 3, and 6 months using the executive function domain tests from the neuropsychological test battery.
Change in Mini-Mental State Examination (MMSE) score 6 months MMSE will be administered at the baseline, 3, and 6 months to determine cognitive change.
Change in visuospatial function 6 months Change in visuospatial function will be assessed at the baseline, 3, and 6 months using the visuospatial function domain tests from the neuropsychological test battery.
Change in brain MRI markers 6 months Changes in brain MRI-derived normalized measures of total brain volume (cubic centimetres) and hippocampal volume (cubic centimetres) and white/grey matter, segmented grey matter regions, white matter lesions, the thickness of segmented cortical regions, microbleeds, perivascular spaces, brain atrophy, micro-infarcts, and white matter hyperintensities. Change of functional connectivity measured using correlation coefficient of functional magnetic resonance imaging (fMRI) signal between brain regions. We will construct an overall brain health score as the outcome. Brain MRI will be assessed at the baseline and 6 months.
Change in memory function 6 months Change in memory function will be assessed at the baseline, 3, and 6 months using the memory domain tests from the neuropsychological test battery.
Trial Locations
- Locations (1)
Second Affiliated Hospital, Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China