MIND Diet to Improve Cognitive Function in Mild Stroke Patients (MINDICOMS) II

Zhejiang University

Status: Enrolling

Conditions: Cerebrovascular; Disorder, Thrombotic; Cognitive Change; Stroke; Dementia

Treatments: Behavioral: General dietary advice; Behavioral: Localized MIND diet intervention; Other: Routine medical care

Study type: Interventional

Funder types: Other

Identifiers

NCT06331247

20230520-2

Details and patient eligibility

About

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.

Full description

Mediterranean-DASH (Dietary Approach to Stop Hypertension) Intervention for Neurodegenerative Delay (MIND) Diet and Cognitive Decline in Mild Stroke Patients (MINDICOMS) II 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 35 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

60 participants in 2 patient groups, including a placebo group

Control arm

Placebo Comparator group

Description:

Usual medical care (including general dietary advice).

Treatment:

Behavioral: General dietary advice

Other: Routine medical care

MIND diet intervention arm

Active Comparator group

Description:

Usual medical care (including general dietary advice) plus the MIND diet intervention.

Treatment:

Behavioral: Localized MIND diet intervention

Behavioral: General dietary advice

Other: Routine medical care