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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06331247
• Other study ID #: 20230520-2
• Status: Recruiting
• Phase: N/A
• Start date: March 18, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: Zhejiang University
• Contact: Changzheng Yuan, ScD
• Phone: 8617326860291
• Email: chy478[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebrovascular Disorders
• Cognitive Change
• Dementia
• Stroke

Intervention

Behavioral:
• General dietary advice
General dietary advice according to the Chinese Dietary Guidelines 2022.
• Localized MIND diet intervention
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.

Other:
• Routine medical care
Routine medical care and follow-ups.

Locations

Country	Name	City	State
China	Second Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in the ability of daily life measured using the Activities of Daily Living Scale (ADL)	To evaluate the effect on the ability of daily life of the MIND diet intervention. Evaluations will be conducted in 0, 3, and 6 months respectively.	6 months
Other	Change in the ability of daily life measured using the Instrumental Activities of Daily Living Scale (IADL)	To evaluate the effect on the ability of daily life of the MIND diet intervention. Evaluations will be conducted in 0, 3, and 6 months respectively.	6 months
Other	Change in depressive status measured using the Patient Health Questionnaire (PHQ-9)	To evaluate the effect on the depressive status of the MIND diet intervention. Evaluations will be conducted in 0, 3, and 6 months respectively.	6 months
Other	Change in anxiety status measured using the General Anxiety Disorder-7 (GAD-7)	To evaluate the effect on the anxiety status of the MIND diet intervention. Evaluations will be conducted in 0, 3, and 6 months respectively.	6 months
Other	Changes in plasma metabolic profiles measured using metabolome analysis	To evaluate the effect on plasma metabolites of the MIND diet intervention. We will assay the metabolome using liquid chromatography-mass spectrometry (LC-MS) and construct an overall metabolic score of the diet as the outcome. Evaluations will be conducted in 0 and 6 months respectively.	6 months
Other	Changes in plasma inflammatory biomarker panel	To evaluate the effect on systematic inflammation of the MIND diet intervention. We will assay IFN-?, interleukin (IL)-10, IL-12p70, IL-13, IL-1ß, IL-2, IL4, IL6, IL-8, tumor necrosis factor (TNF)-a, and C reactive protein (CRP) and construct an overall plasma inflammatory biomarker score as the outcome. Evaluations will be conducted in 0 and 6 months respectively.	6 months
Other	Changes in the intestinal microbiome	To evaluate the effect on intestinal microbiome biodiversity and abundance in specific species in faecal samples of the MIND diet intervention. We will assay microbiome using 16S ribosomal RNA (rRNA) sequencing and construct an overall intestinal microbiome score as the outcome. Evaluations will be conducted in 0 and 6 months respectively.	6 months
Primary	Change in global cognitive function	Global cognitive function assessment is based on a battery of 18 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.	6 months
Primary	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.	6 months
Secondary	Change in Montreal Cognitive Assessment (MoCA) score	MoCA will be administered at the baseline, 3, and 6 months to determine cognitive change.	6 months
Secondary	Change in Mini-Mental State Examination (MMSE) score	MMSE will be administered at the baseline, 3, and 6 months to determine cognitive change.	6 months
Secondary	Change in brain MRI markers	Changes in brain MRI-derived normalized measures of total brain volume (cubic centimetres) and hippocampal volume (cubic centimetres) and white/grey matter, segmented grey matter regions, white matter lesions, the thickness of segmented cortical regions, microbleeds, perivascular spaces, brain atrophy, micro-infarcts, and white matter hyperintensities. Change of functional connectivity measured using correlation coefficient of functional magnetic resonance imaging (fMRI) signal between brain regions. We will construct an overall brain health score as the outcome. Brain MRI will be assessed at the baseline and 6 months.	6 months
Secondary	Change in memory function	Change in memory function will be assessed at the baseline, 3, and 6 months using the memory domain tests from the neuropsychological test battery.	6 months
Secondary	Change in language function	Change in language function will be assessed at the baseline, 3, and 6 months using the language domain tests from the neuropsychological test battery.	6 months
Secondary	Change in executive function	Change in executive function will be assessed at the baseline, 3, and 6 months using the executive function domain tests from the neuropsychological test battery.	6 months
Secondary	Change in visuospatial function	Change in visuospatial function will be assessed at the baseline, 3, and 6 months using the visuospatial function domain tests from the neuropsychological test battery.	6 months