Cognitive FunctionNCT06417749
MIND Diet and Cognitive Function in Middle-aged and Older Adults
A study testing Intervention arm in people with Cognitive Function and Dementia, run by Zhejiang University at 1 site in China.
Trial summary
A 12-month cluster-randomized controlled trial designed to test the effect of the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet education on the rate of cognitive change and several other secondary outcomes in 1200 adults aged 40-69 years. Read more about this study
- Who is it for?
- Ages 40 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Function, Dementia
- What is being tested?
- Intervention arm
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 10 May 2024to 10 Oct 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 40 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Normal chewing function, able to eat hard foods such as nuts.
- Willing to participate and sign an informed consent form.
- Able to understand research procedures and adhere to them throughout the entire study period.
Who cannot join
- Participation in or have participated in other clinical trial studies within the past year.
- Medication to treat Alzheimer's or Parkinson's disease.
- Diagnosis of severe chronic diseases, such as cancer.
Trial locations and contacts
1 site in 1 country.
China1 site
Mutiple Counties
Taian, Shandong, 271000
Changzheng Yuan, ScD, (86)17326860291, chy478@zju.edu.cn
Changzheng Yuan, ScD
About this study
A 12-month cluster-randomized controlled trial designed to test the effect of the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet education on the rate of cognitive change and several other secondary outcomes in 1200 adults aged 40-69 years.
Read the detailed description
Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) Diet and Cognitive Decline in Middle-aged and Elderly People is a 12-month cluster-randomized controlled trial designed to test the effect of the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet education on the rate of cognitive change and several other secondary outcomes in 1200 adults aged 40-69 years. 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 education 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 legumes, 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 cluster randomization design comparing the effects on cognitive change of the MIND intervention diet education among 1200 adults aged 40-69 years. Secondary outcomes will include dietary behavior changes, health status changes, etc. The proposed study is sited at Taian, Shandong, China.
- Conditions
- Cognitive Function, Dementia
- Being tested
- Control arm, Intervention arm
- Keywords
- Cognitive Function, Dietary Pattern
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control armBehavioural
Participants will receive a copy of the Chinese Dietary Guidelines leaflet at baseline.
Intervention armBehavioural
Participants will be given three MIND diet education videos on different topics at baseline and during follow-up. In addition, each participant will receive a MIND diet education brochure at baseline and some food supply during follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Control arm | Placebo comparator | General dietary advice Receives: Behavioral: Control arm |
| Intervention arm | Active comparator | MIND diet education Receives: Behavioral: Intervention arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 5-min Montreal Cognitive Assessment (MoCA) score
Cognitive function will be assessed using the MoCA at baseline and during follow-up.
Measured: 12 months
Secondary outcomes (3)
Change in EuroQol Five Dimensions (EQ-5D) scale
The 5-level EQ-5D (EQ-5D-5L) will be used to assess life quality. Evaluations will be conducted at baseline and during follow-up.
Measured: 12 months
Change in 8-Item Alzheimer's Diseases Screening Tool (AD-8) score
AD-8 will be used to assess cognitive function. Evaluations will be conducted at baseline and during follow-up.
Measured: 12 months
Change in Mediterranean-Dietary Approach to Stop Hypertension (DASH) Intervention for Neurodegenerative Delay (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. Evaluations will be conducted at baseline and during follow-up.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start10 May 2024 (estimated)
- Primary completion10 May 2025 (estimated)
- Study completion10 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive FunctionStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- 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 and the other being the intervention arm (MIND diet education and food supply).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Shandong University
- Responsible party
- Principal investigator, Changzheng Yuan, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06417749
- Sponsor's protocol ID
- LL20240353
- Status last verified
- May 2024
- First submitted
- 12 May 2024
- Last updated
- 16 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Interested collaborators may put in a request.
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MIND Diet and Cognitive Function in Middle-aged and Older Adults
- ClinicalTrials.gov ID
- NCT06417749
- Acronym / sponsor ID
- LL20240353
- Conditions
- Cognitive Function, Dementia
- Keywords
- Cognitive Function, Dietary Pattern
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Shandong University
- Study start
- 10 May 2024 (estimated)
- Primary completion
- 10 May 2025 (estimated)
- Study completion
- 10 Oct 2025 (estimated)
- First posted
- 16 May 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 12-month cluster-randomized controlled trial designed to test the effect of the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet education on the rate of cognitive change and several other secondary outcomes in 1200 adults aged 40-69 years.
Detailed description
Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) Diet and Cognitive Decline in Middle-aged and Elderly People is a 12-month cluster-randomized controlled trial designed to test the effect of the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet education on the rate of cognitive change and several other secondary outcomes in 1200 adults aged 40-69 years. 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 education 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 legumes, 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 cluster randomization design comparing the effects on cognitive change of the MIND intervention diet education among 1200 adults aged 40-69 years. Secondary outcomes will include dietary behavior changes, health status changes, etc. The proposed study is sited at Taian, Shandong, China.
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 and the other being the intervention arm (MIND diet education and food supply).
| Arm | Type | Receives |
|---|---|---|
| Control arm | Placebo comparator | Behavioral: Control armGeneral dietary advice |
| Intervention arm | Active comparator | Behavioral: Intervention armMIND diet education |
Who may qualify
- Ages
- 40 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Normal chewing function, able to eat hard foods such as nuts.
- Willing to participate and sign an informed consent form.
- Able to understand research procedures and adhere to them throughout the entire study period.
Key exclusion criteria (3 listed)
- Participation in or have participated in other clinical trial studies within the past year.
- Medication to treat Alzheimer's or Parkinson's disease.
- Diagnosis of severe chronic diseases, such as cancer.
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 |
|---|---|---|
| Control armParticipants will receive a copy of the Chinese Dietary Guidelines leaflet at baseline. | Behavioural | Control arm |
| Intervention armParticipants will be given three MIND diet education videos on different topics at baseline and during follow-up. In addition, each participant will receive a MIND diet education brochure at baseline and some food supply during follow-up. | Behavioural | Intervention arm |
Primary outcome
Change in 5-min Montreal Cognitive Assessment (MoCA) score
Time frame: 12 months
Cognitive function will be assessed using the MoCA at baseline and during follow-up.
3 secondary outcomes
Change in EuroQol Five Dimensions (EQ-5D) scale
Time frame: 12 months
Change in 8-Item Alzheimer's Diseases Screening Tool (AD-8) score
Time frame: 12 months
Change in Mediterranean-Dietary Approach to Stop Hypertension (DASH) Intervention for Neurodegenerative Delay (MIND) diet score
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: No. Interested collaborators may put in a request.
Related trials for Cognitive Function
RecruitingObservational study
Cannabis Abstinence and Neurocognitive Assessment in Adolescence
Cannabis Dependence, Harmful Use
Not yet recruiting
Effects of Cannabidiol on Memory and Attention in Adults Aged 60-70: A Pilot Study
Healthy Aging, Cognition
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
Recruiting
Effects of Moderate Exercise and Cyclic Sighing on Stress, Cognition and Physiological Markers in Young Adults
Stress
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention arm in people with Cognitive Function and Dementia, 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 3 inclusion and 3 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 16 May 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 5-min Montreal Cognitive Assessment (MoCA) score (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2024.