MIND Diet to Improve Cognitive Function in Mild Stroke Patients (MINDICOMS) II (NCT06331247) | Clinical Trial Compass
UnknownNot Applicable
MIND Diet to Improve Cognitive Function in Mild Stroke Patients (MINDICOMS) II
China60 participantsStarted 2024-03-18
Plain-language 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.
Who can participate
Age range35 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
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