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To examine the effects of a 1-year cluster-randomized controlled intervention of MIND diet on cognitive function among 240 participants with mild cognitive function (MCI) aged 50 years and above from 4 communities.
The current study is a 1-year cluster-randomized controlled intervention trial designed to examine whether the a localized modified Mediterranean-Dietary Approaches to Stop Hypertension (DASH) dietary intervention for neurodegenerative delay (MIND) diet will improve cognitive function among 240 participants with MCI from 4 communities. The modified MIND diet recommends 11 brain healthy food groups (green leafy vegetables, dark red and yellow vegetables, other vegetables, nuts, berries, beans, whole grains, seafood, poultry, olive/tea-seed oil and green tea) and limits intake of 4 unhealthy food groups (red meat and products, animal oil, pastries and sweets, and fried/fast food). This study will randomly assign 240 MCI participants to two groups: A) MIND diet intervention group and B) control group, and estimate the cognitive and biological impacts of the 1-year intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MIND diet intervention | Experimental | Participants in the MIND diet group will receive an education program on a localized MIND diet for 1-year, and will be routinely followed up and given advice on other healthy lifestyles. |
|
| Control group | Active Comparator | Participants in the control group will be routinely followed up and given general advice on healthy lifestyle. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MIND diet education | Behavioral | An intensified education program following a localized modified MIND diet for 1 year, which recommends 11 brain healthy food groups (green leafy vegetables, dark red and yellow vegetables, other vegetables, nuts, berries, beans, whole grains, seafood, poultry, olive/tea-seed oil and green tea) and limits intake of 4 unhealthy food groups (red meat and products, animal oil, pastries and sweets, and fried/fast food). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Global Cognition measured by comprehensive Neuropsychological Test Battery (NTB) | Global cognitive performance (composite z-score) measured by comprehensive Neuropsychological Test Battery (NTB). The z-score calculation will use the population mean and standard deviation, and a higher z-score indicates better cognitive performance. | Up to one year |
| Change in Domain-specific Cognition | NTB domain-specific cognitive performance (composite z-score) for memory, executive function, attention, language, visuomotor speed and visuoconstruction. The z-score calculation will use the population mean and standard deviation, and a higher z-score indicates better cognitive performance. | Up to one year |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Clinical Dementia Rating-Sum of Boxes (CDR-SB) | The Clinical Dementia Rating-Sum of Boxes (CDR-SB) is scored from 0 to 18. Higher scores reflect worse performance. | Up to one year |
| Change in Alzheimer's Disease Cooperative Study Activities of Daily Living Mild Cognitive Impairment-Activities of Daily Living Inventory (ADCS MCI-ADL) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in dietary behaviour measured using a food frequency questionnaire | To evaluate the behavioural effect of dietary changes of the MIND diet intervention package. Exploratory aim 1b: Changes in plasma levels of carotenoids, fatty acids, and vitamins (including folic acid). To evaluate the effect on nutritional biomarkers of the MIND diet intervention. | Up to one year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Changzheng Yuan, ScD | Contact | 86-17326860291 | chy478@zju.edu.cn | |
| Xin Xu, PhD | Contact | 86-13575760802 | xuxinsummer@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Changzheng Yuan, ScD | Zhejiang University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310058 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37133875 | Background | 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. | |
| 37105521 |
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When applicable, electronic data will be made available after trial completion.
When the final research data published, the data and other related resources would be shared in the Global Alzheimer's Association Interactive Network (GAAIN).
Review & Approval by the Publications and Presentation Committee.
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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Single (outcomes assessor)
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| Routine follow-up and general advice | Behavioral | Routine follow-up administered by trained staff. |
|
The Alzheimer's Disease Cooperative Study Activities of Daily Living-Mild Cognitive Impairment-Activities of Daily Living Inventory (ADCS MCI-ADL) is scored from 0 to 53. Higher scores reflect better performance. |
| Up to one year |
| Change in Pittsburgh Sleep Quality Index (PSQI) | The Pittsburgh Sleep Quality Index (PSQI) is scored from 0 to 21. Higher scores indicate worse sleep quality. | Up to one year |
| Change in Montreal Cognitive Assessment (MoCA) score | MoCA will be assessed to determine cognitive change. | Up to one year |
| Change in depressive status measured using the Geriatric Depression Scale (GDS) | To evaluate the effect on the depressive status of the MIND diet intervention. A higher GDS score indicates more severe depressive symptoms. | Up to one year |
| 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. A higher GAD-7 score indicates more severe anxious symptoms. | Up to one year |
| 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. | Up to one year |
| Changes in plasma inflammatory biomarkers | To evaluate the effect on systematic inflammation of the MIND diet intervention. We will assay interferon-γ, Interleukin (IL)-10, IL-12p70, IL-13, IL-1β, IL-2, IL-4, IL-6, IL-8, Tumor Necrosis Factor alpha, and C-Reaction Protein and construct an overall plasma inflammatory biomarker score as the outcome. | Up to one year |
| 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 16-S ribosomal RNA (rRNA) sequencing and construct an overall intestinal microbiome score as the outcome. | Up to one year |
| Huang 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. |
| 26086182 | Background | Morris 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. |
| 33434704 | Background | Liu 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. |