MIND Diet and Cognitive Function in Adults With MCI

Effect of MIND Diet Intervention on Cognitive Function in Adults With Mild Cognitive Impairment

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.

Study Overview

• Status: Recruiting
• Conditions: Mild Cognitive Impairment; Cognitive Function; Cognitive Decline
• Intervention / Treatment: Behavioral: MIND diet education; Behavioral: Routine follow-up and general advice

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.

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Changzheng Yuan, ScD; Phone Number: 86-17326860291; Email: chy478@zju.edu.cn
• Study Contact Backup: Name: Xin Xu, PhD; Phone Number: 86-13575760802; Email: xuxinsummer@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310058
      • Recruiting
      • Zhejiang University School of Medicine
      • Contact: Changzheng Yuan, ScD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MIND diet intervention; 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.	Behavioral: MIND 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).; Behavioral: Routine follow-up and general advice; Routine follow-up administered by trained staff.
Active Comparator: Control group; Participants in the control group will be routinely followed up and given general advice on healthy lifestyle.	Behavioral: Routine follow-up and general advice; Routine follow-up administered by trained staff.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Other Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Zhejiang University
• Investigators: Study Chair: Changzheng Yuan, ScD, Zhejiang University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2023
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: July 13, 2023
• First Submitted That Met QC Criteria: August 3, 2023
• First Posted (Actual): August 4, 2023

Study Record Updates

• Last Update Posted (Actual): August 4, 2023
• Last Update Submitted That Met QC Criteria: August 3, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: AARG-22-928604

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: When applicable, electronic data will be made available after trial completion.
• IPD Sharing Time Frame: When the final research data published, the data and other related resources would be shared in the Global Alzheimer's Association Interactive Network (GAAIN).
• IPD Sharing Access Criteria: Review & Approval by the Publications and Presentation Committee.
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No