MIND Diet to Improve Cognitive Function in Mild Stroke Patients

N/AActive Not RecruitingNCT05921084

Zhejiang University60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Conditions

Dementia Cognitive Change Stroke Cerebral Infarction Transient Ischemic Attack

Interventions

MIND diet interventionBEHAVIORAL

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 adviceBEHAVIORAL

General dietary advice

Eligibility

Sex: ALLMin age: 35 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Clinically confirmed new cerebral infarction, onset hospitalization time ≤14 days * NHISS 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 * 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 3 years * 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

Locations (1)

Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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