Cognitive Decline, Cognitive Function, Mild Cognitive Impairment
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALMIND diet education
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).
BEHAVIORALRoutine follow-up and general advice
Routine follow-up administered by trained staff.
Sponsors
Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Single (outcomes assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* At risk of cognitive decline: cognitive performance at the mean level or slightly lower than expected for age with no dementia (AD8\>=3 and/or 5-min MoCA \< 11) * Free of physical disabilities that preclude participation in the study * Willing to complete all study-related activities for 24 months * Willing to be randomized to either intervention group
Exclusion criteria
* Allergic to more than one type of food (nuts, berries, olive oil, or fish) * Diagnosed of dementia, severe diabetes mellitus, cardiovascular disease, cancer, thyroid disease, kidney disease, or liver disease * Diagnosed of major depression or other neuropsychological diseases * Severe loss of vision, hearing or communicative ability * Substance abuse within 6 months or heavy alcohol consumption (\> 2 drinks/day for women; \> 3 drinks/day for men).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Global Cognition measured by comprehensive Neuropsychological Test Battery (NTB) | Up to one year | 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. |
| Change in Domain-specific Cognition | Up to one year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Clinical Dementia Rating-Sum of Boxes (CDR-SB) | Up to one year | The Clinical Dementia Rating-Sum of Boxes (CDR-SB) is scored from 0 to 18. Higher scores reflect worse performance. |
| Change in Alzheimer's Disease Cooperative Study Activities of Daily Living Mild Cognitive Impairment-Activities of Daily Living Inventory (ADCS MCI-ADL) | Up to one year | 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. |
| Change in Pittsburgh Sleep Quality Index (PSQI) | Up to one year | The Pittsburgh Sleep Quality Index (PSQI) is scored from 0 to 21. Higher scores indicate worse sleep quality. |
| Change in Montreal Cognitive Assessment (MoCA) score | Up to one year | MoCA will be assessed to determine cognitive change. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes in plasma inflammatory biomarkers | Up to one year | 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. |
| Changes in plasma metabolic profiles measured using metabolome analysis | Up to one year | 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. |
| Change in dietary behaviour measured using a food frequency questionnaire | Up to one year | 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. |
| Change in depressive status measured using the Geriatric Depression Scale (GDS) | Up to one year | To evaluate the effect on the depressive status of the MIND diet intervention. A higher GDS score indicates more severe depressive symptoms. |
| Change in anxiety status measured using the General Anxiety Disorder-7 (GAD-7) | Up to one year | To evaluate the effect on the anxiety status of the MIND diet intervention. A higher GAD-7 score indicates more severe anxious symptoms. |
| Changes in the intestinal microbiome | Up to one year | 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. |
Countries
China
Contacts
Primary ContactChangzheng Yuan, ScD
Backup ContactXin Xu, PhD
Outcome results
None listed