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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
General dietary advice according to the Chinese Dietary Guidelines 2022.
The MIND diet intervention, composed of the consumption of whole grains, dark green leafy vegetables, dark red/yellow vegetables, other vegetables, berries and citrus, poultry, fish and seafoods, beans and legume, nuts, olive and seed oils, and green tea, and restricting red and processed meats, animal fat, fried foods, and sweets and pastries.
Routine medical care and follow-ups.
Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
RECRUITINGChange in global cognitive function
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.
Time frame: 6 months
Change in MIND diet score
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.
Time frame: 6 months
Change in Montreal Cognitive Assessment (MoCA) score
MoCA will be administered at the baseline, 3, and 6 months to determine cognitive change.
Time frame: 6 months
Change in Mini-Mental State Examination (MMSE) score
MMSE will be administered at the baseline, 3, and 6 months to determine cognitive change.
Time frame: 6 months
Change in brain MRI markers
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.
Time frame: 6 months
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Enrollment
60
Change in memory function
Change in memory function will be assessed at the baseline, 3, and 6 months using the memory domain tests from the neuropsychological test battery.
Time frame: 6 months
Change in language function
Change in language function will be assessed at the baseline, 3, and 6 months using the language domain tests from the neuropsychological test battery.
Time frame: 6 months
Change in executive function
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.
Time frame: 6 months
Change in visuospatial function
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.
Time frame: 6 months