Clinical trial NCT05975723: MIND Diet and Cognitive Function in Adults With MCI
Official title: Effect of MIND Diet Intervention on Cognitive Function in Adults With Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment
Cognitive Function
Cognitive Decline
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2023-08-04
Enrollment: 240
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change in Global Cognition measured by comprehensive Neuropsychological Test Battery (NTB)
timeFrame: Up to one year
measure: Change in Domain-specific Cognition
timeFrame: Up to one year
Secondary outcomes:
measure: Change in Clinical Dementia Rating-Sum of Boxes (CDR-SB)
timeFrame: Up to one year
measure: Change in Alzheimer's Disease Cooperative Study Activities of Daily Living Mild Cognitive Impairment-Activities of Daily Living Inventory (ADCS MCI-ADL)
timeFrame: Up to one year
measure: Change in Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Up to one year
measure: Change in Montreal Cognitive Assessment (MoCA) score
timeFrame: Up to one year
Other outcomes:
measure: Change in dietary behaviour measured using a food frequency questionnaire
timeFrame: Up to one year
measure: Change in depressive status measured using the Geriatric Depression Scale (GDS)
timeFrame: Up to one year
measure: Change in anxiety status measured using the General Anxiety Disorder-7 (GAD-7)
timeFrame: Up to one year
measure: Changes in plasma metabolic profiles measured using metabolome analysis
timeFrame: Up to one year
measure: Changes in plasma inflammatory biomarkers
timeFrame: Up to one year
measure: Changes in the intestinal microbiome
timeFrame: Up to one year
Locations:
city: Hangzhou
country: China
facility: Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Zhejiang University
name: Changzheng Yuan, ScD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.