An interventional study of MIND diet intervention and General dietary advice in Dementia, Cognitive Change and Stroke, sponsored by Zhejiang University. Active, not recruiting at 1 site in China. Open to participants aged 35 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-03-19.
Sponsored by Zhejiang University · Not applicable, Interventional, and Prevention
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 the rate of 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 Intervention for Neurodegenerative Delay (MIND) Diet and Cognitive Decline in Mild Stroke Patients 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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's planned enrollment of 60 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Zhejiang University is the lead sponsor of 351 studies on the registry; 165 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Usual medical care (including general dietary advice).
Behavioral: General dietary advice
Usual medical care plus the MIND diet intervention.
Behavioral: MIND diet intervention
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.
General dietary advice
Change in global cognitive function
Global cognitive function assessment is based on a battery of 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) and Mini-Mental State Examination (MMSE) scores
MoCA and MMSE will be assessed at the baseline, 3, and 6 months to determine cognitive change.
Time frame: 6 months
Change in memory function
Change in memory function will be assessed at the baseline, 3, and 6 months using National Institute of Neurologic Disorders and Stroke and the Canadian Stroke Network battery.
Time frame: 6 months
Change in language function
Change in language function will be assessed at the baseline, 3, and 6 months using National Institute of Neurologic Disorders and Stroke and the Canadian Stroke Network battery.
Time frame: 6 months
Change in executive function
Change in executive function will be assessed at the baseline, 3, and 6 months using National Institute of Neurologic Disorders and Stroke and the Canadian Stroke Network battery.
Time frame: 6 months
Change in visuospatial function
Change in visuospatial function will be assessed at the baseline, 3, and 6 months using National Institute of Neurologic Disorders and Stroke and the Canadian Stroke Network battery.
Time frame: 6 months
Change in Eight-item Interview to Differentiate Aging and Dementia (AD8) Dementia Screening score
AD8 will be assessed 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 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
Change in dietary behaviour measured using a food frequency questionnaire
To evaluate the behavioural effect of dietary changes of the MIND diet intervention package. Evaluations will be conducted in 0, 3, and 6 months respectively. Exploratory aim 1b: Changes in plasma levels of carotenoids, fatty acids, and vitamins (including folic acid). To evaluate the effect on nutritional biomarkers of the MIND diet intervention. Evaluations will be conducted in 0 and 6 months respectively.
Time frame: 6 months
Change in the ability of daily life measured using the Activities of Daily Living Scale (ADL)
To evaluate the effect on the ability of daily life of the MIND diet intervention. Evaluations will be conducted in 0, 3, and 6 months respectively.
Time frame: 6 months
Change in the ability of daily life measured using the Instrumental Activities of Daily Living Scale (IADL)
To evaluate the effect on the ability of daily life of the MIND diet intervention. Evaluations will be conducted in 0, 3, and 6 months respectively.
Time frame: 6 months
Change in depressive status measured using the Patient Health Questionnaire (PHQ-9)
To evaluate the effect on the depressive status of the MIND diet intervention. Evaluations will be conducted in 0, 3, and 6 months respectively.
Time frame: 6 months
Change in anxiety status measured using the General Anxiety Disorder-7 (GAD-7)
To evaluate the effect on the anxiety status of the MIND diet intervention. Evaluations will be conducted in 0, 3, and 6 months respectively.
Time frame: 6 months
Changes in plasma metabolic profiles measured using metabolome analysis
To evaluate the effect on plasma metabolites of the MIND diet intervention. We will assay the metabolome using liquid chromatography-mass spectrometry (LC-MS) and construct an overall metabolic score of the diet as the outcome. Evaluations will be conducted in 0 and 6 months respectively.
Time frame: 6 months
Changes in plasma inflammatory biomarkers
To evaluate the effect on systematic inflammation of the MIND diet intervention. We will assay IFN-γ, IL-10, IL-12p70, IL-13, IL-1β, IL-2, IL4, IL6, IL-8, TNF-α, and CRP and construct an overall plasma inflammatory biomarker score as the outcome. Evaluations will be conducted in 0 and 6 months respectively.
Time frame: 6 months
Changes in the intestinal microbiome
To evaluate the effect on intestinal microbiome biodiversity and abundance in specific species in faecal samples of the MIND diet intervention. We will assay microbiome using 16S ribosomal RNA (rRNA) sequencing and construct an overall intestinal microbiome score as the outcome. Evaluations will be conducted in 0 and 6 months respectively.
Time frame: 6 months
Plan to share: No — Interested collaborators may put in a request.
This study is active, not recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Zhejiang University