DementiaMINDICOMSNCT05921084
MIND Diet to Improve Cognitive Function in Mild Stroke Patients
A study testing MIND diet intervention and General dietary advice in people with Dementia and Cognitive Change, 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 the rate of cognitive change and several other secondary outcomes through a randomized controlled trial in 60 mild… Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Dementia, Cognitive Change, Stroke
- What is being tested?
- MIND diet intervention and General dietary advice
- 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
- 23 Jul 2023to 1 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
- NHISS 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
- 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 3 years
- Diagnosis of depression, bipolar disorder, or other mental illnesses
Show all 9Show fewer
- 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
Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310058
About this study
Official title: Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) Diet to Improve Cognitive Function in Mild Stroke Patients: A Pilot Randomized Controlled 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 the rate of 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 Intervention for Neurodegenerative Delay (MIND) Diet and Cognitive Decline in Mild Stroke Patients 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
- MIND diet intervention, General dietary advice
- Keywords
- Cognitive function, Dietary pattern
- Medical subject headings
- Dementia, Stroke, Cerebral Infarction, Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
General dietary adviceBehavioural
General dietary advice
| Study group | Role | What they receive |
|---|---|---|
| Control arm | Placebo comparator | Usual medical care (including general dietary advice). Receives: Behavioral: General dietary advice |
| MIND diet intervention arm | Active comparator | Usual medical care plus the MIND diet intervention. Receives: Behavioral: MIND diet intervention |
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 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) and Mini-Mental State Examination (MMSE) scores
MoCA and MMSE will be assessed at the baseline, 3, and 6 months to determine cognitive change.
Measured: 6 months
Change in memory function
Change in memory function will be assessed at the baseline, 3, and 6 months using National Institute of Neurologic Disorders and Stroke and the Canadian Stroke Network battery.
Measured: 6 months
Change in language function
Change in language function will be assessed at the baseline, 3, and 6 months using National Institute of Neurologic Disorders and Stroke and the Canadian Stroke Network battery.
Measured: 6 months
Change in executive function
Change in executive function will be assessed at the baseline, 3, and 6 months using National Institute of Neurologic Disorders and Stroke and the Canadian Stroke Network battery.
Measured: 6 months
Change in visuospatial function
Change in visuospatial function will be assessed at the baseline, 3, and 6 months using National Institute of Neurologic Disorders and Stroke and the Canadian Stroke Network battery.
Measured: 6 months
Change in Eight-item Interview to Differentiate Aging and Dementia (AD8) Dementia Screening score
AD8 will be assessed 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 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start23 Jul 2023
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Collaborators
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Responsible party
- Principal investigator, Changzheng Yuan, Zhejiang University
- Investigators
- Changzheng Yuan, ScD, Principal investigator, Zhejiang University School of MedicineLusha Tong, PhD, 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
- NCT05921084
- Sponsor's protocol ID
- 20230520
- Acronym
- MINDICOMS
- Status last verified
- Mar 2024
- First submitted
- 1 Jun 2023
- Last updated
- 19 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Interested collaborators may put in a request.
Publications
Chen H, Dhana K, Huang Y, Huang L, Tao Y, Liu X, Melo van Lent D, Zheng Y, Ascherio A, Willett W, Yuan C. Association of the Mediterranean Dietary Approaches to Stop Hypertension Intervention for Neurodegenerative Delay (MIND) Diet With the Risk of Dementia. JAMA Psychiatry. 2023 Jun 1;80(6):630-638. doi: 10.1001/jamapsychiatry.2023.0800.
PubMed 37133875Huang L, Tao Y, Chen H, Chen X, Shen J, Zhao C, Xu X, He M, Zhu D, Zhang R, Yang M, Zheng Y, Yuan C. Mediterranean-Dietary Approaches to Stop Hypertension Intervention for Neurodegenerative Delay (MIND) Diet and Cognitive Function and its Decline: A Prospective Study and Meta-analysis of Cohort Studies. Am J Clin Nutr. 2023 Jul;118(1):174-182. doi: 10.1016/j.ajcnut.2023.04.025. Epub 2023 Apr 25.
PubMed 37105521Morris MC, Tangney CC, Wang Y, Sacks FM, Barnes LL, Bennett DA, Aggarwal NT. MIND diet slows cognitive decline with aging. Alzheimers Dement. 2015 Sep;11(9):1015-22. doi: 10.1016/j.jalz.2015.04.011. Epub 2015 Jun 15.
PubMed 26086182Liu X, Morris MC, Dhana K, Ventrelle J, Johnson K, Bishop L, Hollings CS, Boulin A, Laranjo N, Stubbs BJ, Reilly X, Carey VJ, Wang Y, Furtado JD, Marcovina SM, Tangney C, Aggarwal NT, Arfanakis K, Sacks FM, Barnes LL. Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) study: Rationale, design and baseline characteristics of a randomized control trial of the MIND diet on cognitive decline. Contemp Clin Trials. 2021 Mar;102:106270. doi: 10.1016/j.cct.2021.106270. Epub 2021 Jan 9.
PubMed 33434704Lin 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 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) Diet to Improve Cognitive Function in Mild Stroke Patients: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05921084
- Acronym / sponsor ID
- MINDICOMS / 20230520
- Keywords
- Cognitive function, Dietary pattern
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Study start
- 23 Jul 2023 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 27 Jun 2023 (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 the rate of 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 Intervention for Neurodegenerative Delay (MIND) Diet and Cognitive Decline in Mild Stroke Patients 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 adviceUsual medical care (including general dietary advice). |
| MIND diet intervention arm | Active comparator | Behavioral: MIND diet interventionUsual medical care 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
- NHISS 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
- 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 3 years
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 |
|---|---|---|
| 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 |
| General dietary adviceGeneral dietary advice | Behavioural | Control arm |
Primary outcome
Change in global cognitive function
Time frame: 6 months
Global cognitive function assessment is based on a battery of 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) and Mini-Mental State Examination (MMSE) scores
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
Change in Eight-item Interview to Differentiate Aging and Dementia (AD8) Dementia Screening score
Time frame: 6 months
Change in brain MRI markers
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 19 Mar 2024.
- Background: PubMed 37133875Chen H, Dhana K, Huang Y, Huang L, Tao Y, Liu X, Melo van Lent D, Zheng Y, Ascherio A, Willett W, Yuan C. Association of the Mediterranean Dietary Approaches to Stop Hypertension Intervention for Neurodegenerative Delay (MIND) Diet With the Risk of Dementia. JAMA Psychiatry. 2023 Jun 1;80(6):630-638. doi: 10.1001/jamapsychiatry.2023.0800.
- Background: PubMed 37105521Huang L, Tao Y, Chen H, Chen X, Shen J, Zhao C, Xu X, He M, Zhu D, Zhang R, Yang M, Zheng Y, Yuan C. Mediterranean-Dietary Approaches to Stop Hypertension Intervention for Neurodegenerative Delay (MIND) Diet and Cognitive Function and its Decline: A Prospective Study and Meta-analysis of Cohort Studies. Am J Clin Nutr. 2023 Jul;118(1):174-182. doi: 10.1016/j.ajcnut.2023.04.025. Epub 2023 Apr 25.
- Background: PubMed 26086182Morris MC, Tangney CC, Wang Y, Sacks FM, Barnes LL, Bennett DA, Aggarwal NT. MIND diet slows cognitive decline with aging. Alzheimers Dement. 2015 Sep;11(9):1015-22. doi: 10.1016/j.jalz.2015.04.011. Epub 2015 Jun 15.
- Background: PubMed 33434704Liu X, Morris MC, Dhana K, Ventrelle J, Johnson K, Bishop L, Hollings CS, Boulin A, Laranjo N, Stubbs BJ, Reilly X, Carey VJ, Wang Y, Furtado JD, Marcovina SM, Tangney C, Aggarwal NT, Arfanakis K, Sacks FM, Barnes LL. Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) study: Rationale, design and baseline characteristics of a randomized control trial of the MIND diet on cognitive decline. Contemp Clin Trials. 2021 Mar;102:106270. doi: 10.1016/j.cct.2021.106270. Epub 2021 Jan 9.
- 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
Zhejiang University School of Medicine
Lusha Tong, PhD 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 MIND diet intervention and General dietary advice in people with Dementia and Cognitive Change, 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 19 Mar 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 NCT05921084, which also lists 5 linked publications.
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 19 Mar 2024.