MIND diet to enhance cognitive function in mild stroke patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot randomized controlled trial investigates the effects of the MIND diet, a combination of the Mediterranean and DASH diets, on cognitive change in mild stroke patients aged 35-70 years without dementia. Over six months, 60 participants will receive either the MIND diet along with usual medical care or just usual medical care. The study aims to assess various outcomes, including cognitive function, dietary behavior, and mental health changes, while also examining potential mediators and modifiers of the diet's effects. The trial is designed to provide insights into dietary interventions for improving cognitive health post-stroke.

Why it matters

Who can join: the full rules

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
* Diagnosis of inflammatory bowel disease or other malabsorption-related gastrointestinal diseases
* History of alcohol or drug abuse

Where it's running

• Second Affiliated Hospital, Zhejiang University School of Medicine
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Principal investigator: Changzheng Yuan, ScD — Second Affiliated Hospital, Zhejiang University School of Medicine
• Study coordinator: Changzheng Yuan, ScD
• Email: chy478@zju.edu.cn
• Phone: 8617326860291

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.