- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06331247
MIND Diet to Improve Cognitive Function in Mild Stroke Patients (MINDICOMS) II
April 2, 2024 updated by: Changzheng Yuan, Zhejiang University
MIND Diet to Improve Cognitive Function in Mild Stroke Patients (MINDICOMS) II: A Pilot Randomized Control Trial
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.
Study Overview
Status
Recruiting
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Changzheng Yuan, ScD
- Phone Number: 8617326860291
- Email: chy478@zju.edu.cn
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310058
- Recruiting
- Second Affiliated Hospital, Zhejiang University School of Medicine
-
Contact:
- Lusha Tong, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Control arm
Usual medical care (including general dietary advice).
|
General dietary advice according to the Chinese Dietary Guidelines 2022.
Routine medical care and follow-ups.
|
Active Comparator: MIND diet intervention arm
Usual medical care (including general dietary advice) plus the MIND diet intervention.
|
General dietary advice according to the Chinese Dietary Guidelines 2022.
Routine medical care and follow-ups.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in MIND diet score
Time Frame: 6 months
|
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
|
Change in global cognitive function
Time Frame: 6 months
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Montreal Cognitive Assessment (MoCA) score
Time Frame: 6 months
|
MoCA will be administered at the baseline, 3, and 6 months to determine cognitive change.
|
6 months
|
Change in Mini-Mental State Examination (MMSE) score
Time Frame: 6 months
|
MMSE will be administered at the baseline, 3, and 6 months to determine cognitive change.
|
6 months
|
Change in brain MRI markers
Time Frame: 6 months
|
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
|
Change in memory function
Time Frame: 6 months
|
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
|
Change in language function
Time Frame: 6 months
|
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
|
Change in executive function
Time Frame: 6 months
|
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
|
Change in visuospatial function
Time Frame: 6 months
|
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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the ability of daily life measured using the Activities of Daily Living Scale (ADL)
Time Frame: 6 months
|
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
|
Change in the ability of daily life measured using the Instrumental Activities of Daily Living Scale (IADL)
Time Frame: 6 months
|
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
|
Change in depressive status measured using the Patient Health Questionnaire (PHQ-9)
Time Frame: 6 months
|
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
|
Change in anxiety status measured using the General Anxiety Disorder-7 (GAD-7)
Time Frame: 6 months
|
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
|
Changes in plasma metabolic profiles measured using metabolome analysis
Time Frame: 6 months
|
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
|
Changes in the intestinal microbiome
Time Frame: 6 months
|
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
|
Changes in plasma inflammatory biomarker panel
Time Frame: 6 months
|
To evaluate the effect on systematic inflammation of the MIND diet intervention.
We will assay IFN-γ, interleukin (IL)-10, IL-12p70, IL-13, IL-1β, IL-2, IL4, IL6, IL-8, tumor necrosis factor (TNF)-α, 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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Xin Xu, PhD, Zhejiang University School of Medicine
- Principal Investigator: Changzheng Yuan, ScD, Second Affiliated Hospital, Zhejiang University School of Medicine
- Principal Investigator: Lusha Tong, MD, Second Affiliated Hospital, Zhejiang University School of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 18, 2024
Primary Completion (Estimated)
December 31, 2025
Study Completion (Estimated)
December 31, 2025
Study Registration Dates
First Submitted
March 20, 2024
First Submitted That Met QC Criteria
March 20, 2024
First Posted (Actual)
March 26, 2024
Study Record Updates
Last Update Posted (Actual)
April 4, 2024
Last Update Submitted That Met QC Criteria
April 2, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20230520-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Interested collaborators may put in a request.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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