DementiaNCT06331247
MIND Diet to Improve Cognitive Function in Mild Stroke Patients (MINDICOMS) II
A study testing General dietary advice, Localized MIND diet intervention and Routine medical care in people with Dementia and Stroke, run by Zhejiang University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Dementia, Stroke, Cognitive Change
- What is being tested?
- General dietary advice, Localized MIND diet intervention and Routine medical care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 18 Mar 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310058
Lusha Tong, PhD
About this study
Official title: 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.
Read the 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.
- Being tested
- General dietary advice, Localized MIND diet intervention, Routine medical care
- Keywords
- Stroke, Cognitive Change, MIND diet, Dietary pattern
- Medical subject headings
- Dementia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General dietary adviceBehavioural
General dietary advice according to the Chinese Dietary Guidelines 2022.
Localized MIND diet interventionBehavioural
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.
Routine medical careOther
Routine medical care and follow-ups.
| Study group | Role | What they receive |
|---|---|---|
| Control arm | Placebo comparator | Usual medical care (including general dietary advice). Receives: Behavioral: General dietary advice; Other: Routine medical care |
| MIND diet intervention arm | Active comparator | Usual medical care (including general dietary advice) plus the MIND diet intervention. Receives: Behavioral: General dietary advice; Behavioral: Localized MIND diet intervention; Other: Routine medical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months
Secondary outcomes (7)
Change in Montreal Cognitive Assessment (MoCA) score
MoCA will be administered at the baseline, 3, and 6 months to determine cognitive change.
Measured: 6 months
Change in Mini-Mental State Examination (MMSE) score
MMSE will be administered at the baseline, 3, and 6 months to determine cognitive change.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start18 Mar 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Changzheng Yuan, Zhejiang University
- Investigators
- Changzheng Yuan, ScD, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of MedicineLusha Tong, MD, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of MedicineXin Xu, PhD, Principal investigator, Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06331247
- Sponsor's protocol ID
- 20230520-2
- Status last verified
- Mar 2024
- First submitted
- 20 Mar 2024
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Interested collaborators may put in a request.
Publications
Lin Q, Chen H, Shen J, Tao Y, Tang L, Zhang T, Liu X, Zeng P, He F, Liu C, Xu X, Yuan C, Tong LS. Mediterranean-DASH Intervention for Neurodegenerative Delay Diet to Improve Cognitive Function in Mild Stroke Patients: Rationale and Design of Two Replicate, Pilot Randomized Control Trials. Cerebrovasc Dis. 2026;55(3):400-413. doi: 10.1159/000547148. Epub 2025 Jul 10.
PubMed 40639357
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MIND Diet to Improve Cognitive Function in Mild Stroke Patients (MINDICOMS) II: A Pilot Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06331247
- Acronym / sponsor ID
- 20230520-2
- Keywords
- Stroke, Cognitive Change, MIND diet, Dietary pattern
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 18 Mar 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 26 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Control arm | Placebo comparator | Behavioral: General dietary advice, Other: Routine medical careUsual medical care (including general dietary advice). |
| MIND diet intervention arm | Active comparator | Behavioral: General dietary advice, Behavioral: Localized MIND diet intervention, Other: Routine medical careUsual medical care (including general dietary advice) plus the MIND diet intervention. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| General dietary adviceGeneral dietary advice according to the Chinese Dietary Guidelines 2022. | Behavioural | Control arm, MIND diet intervention arm |
| Localized MIND diet interventionThe 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. | Behavioural | MIND diet intervention arm |
| Routine medical careRoutine medical care and follow-ups. | Other | Control arm, MIND diet intervention arm |
Primary outcome
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.
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.
7 secondary outcomes
Change in Montreal Cognitive Assessment (MoCA) score
Time frame: 6 months
Change in Mini-Mental State Examination (MMSE) score
Time frame: 6 months
Change in brain MRI markers
Time frame: 6 months
Change in memory function
Time frame: 6 months
Change in language function
Time frame: 6 months
Change in executive function
Time frame: 6 months
Change in visuospatial function
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Derived from this study: PubMed 40639357Lin Q, Chen H, Shen J, Tao Y, Tang L, Zhang T, Liu X, Zeng P, He F, Liu C, Xu X, Yuan C, Tong LS. Mediterranean-DASH Intervention for Neurodegenerative Delay Diet to Improve Cognitive Function in Mild Stroke Patients: Rationale and Design of Two Replicate, Pilot Randomized Control Trials. Cerebrovasc Dis. 2026;55(3):400-413. doi: 10.1159/000547148. Epub 2025 Jul 10.
- Individual participant dataSharing planned: No. Interested collaborators may put in a request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Changzheng Yuan, ScD principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
Lusha Tong, MD principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
Xin Xu, PhD principal investigator
Zhejiang University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing General dietary advice, Localized MIND diet intervention and Routine medical care in people with Dementia and Stroke, run by Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Changzheng Yuan, ScD (8617326860291, chy478@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in global cognitive function (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06331247, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024.