Clinical trial NCT06331247: MIND Diet to Improve Cognitive Function in Mild Stroke Patients (MINDICOMS) II
Official title: MIND Diet to Improve Cognitive Function in Mild Stroke Patients (MINDICOMS) II: A Pilot Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dementia
Stroke
Cognitive Change
Cerebrovascular; Disorder, Thrombotic
Keywords: Stroke
Cognitive Change
MIND diet
Dietary pattern
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2024-03-26
Enrollment: 60
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a two-arm parallel design, with one arm being the control arm (usual medical care) and the other being the intervention arm (MIND diet intervention + usual medical care).
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: Change in global cognitive function
timeFrame: 6 months
measure: Change in MIND diet score
timeFrame: 6 months
Secondary outcomes:
measure: Change in Montreal Cognitive Assessment (MoCA) score
timeFrame: 6 months
measure: Change in Mini-Mental State Examination (MMSE) score
timeFrame: 6 months
measure: Change in brain MRI markers
timeFrame: 6 months
measure: Change in memory function
timeFrame: 6 months
measure: Change in language function
timeFrame: 6 months
measure: Change in executive function
timeFrame: 6 months
measure: Change in visuospatial function
timeFrame: 6 months
Other outcomes:
measure: Change in the ability of daily life measured using the Activities of Daily Living Scale (ADL)
timeFrame: 6 months
measure: Change in the ability of daily life measured using the Instrumental Activities of Daily Living Scale (IADL)
timeFrame: 6 months
measure: Change in depressive status measured using the Patient Health Questionnaire (PHQ-9)
timeFrame: 6 months
measure: Change in anxiety status measured using the General Anxiety Disorder-7 (GAD-7)
timeFrame: 6 months
measure: Changes in plasma metabolic profiles measured using metabolome analysis
timeFrame: 6 months
measure: Changes in plasma inflammatory biomarker panel
timeFrame: 6 months
measure: Changes in the intestinal microbiome
timeFrame: 6 months
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, Zhejiang University School of Medicine
name: Changzheng Yuan, ScD
role: PRINCIPAL_INVESTIGATOR
affiliation: Second Affiliated Hospital, Zhejiang University School of Medicine
name: Lusha Tong, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhejiang University School of Medicine
name: Xin Xu, PhD
role: PRINCIPAL_INVESTIGATOR
References: