MIND diet to enhance cognitive function in mild stroke patients

MIND Diet to Improve Cognitive Function in Mild Stroke Patients (MINDICOMS) II: A Pilot Randomized Control Trial

This study is testing if following the MIND diet can help improve thinking and memory in mild stroke patients aged 35-70 who don’t have dementia.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 35 Years to 70 Years
• Sex: All
• Sponsor: Zhejiang University (other)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT06331247 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are mild stroke patients aged 35-70 years who do not have dementia and show signs of cognitive decline.

Not a fit: Patients with a prior diagnosis of dementia or significant cognitive impairment before the stroke may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a dietary approach to improve cognitive function in patients recovering from mild strokes.

How similar studies have performed: Other studies have shown promising results with dietary interventions for cognitive health, suggesting potential success for this approach.

Eligibility criteria

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 this trial is running

Hangzhou, Zhejiang

• 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

Conditions: Dementia, Stroke, Cognitive Change, Cerebrovascular, Disorder, Thrombotic, MIND diet, Dietary pattern