NCT05975723

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

July 26, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 4, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

August 4, 2023

Status Verified

August 1, 2023

Enrollment Period

2 years

First QC Date

July 13, 2023

Last Update Submit

August 3, 2023

Conditions

Mild Cognitive ImpairmentCognitive FunctionCognitive Decline

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Change in Clinical Dementia Rating-Sum of Boxes (CDR-SB)

    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)

    Up to one year

  • Change in Pittsburgh Sleep Quality Index (PSQI)

    Up to one year

  • Change in Montreal Cognitive Assessment (MoCA) score

    Up to one year

Other Outcomes (6)

  • Change in dietary behaviour measured using a food frequency questionnaire

    Up to one year

  • Change in depressive status measured using the Geriatric Depression Scale (GDS)

    Up to one year

  • Change in anxiety status measured using the General Anxiety Disorder-7 (GAD-7)

    Up to one year

  • +3 more other outcomes

Study Arms (2)

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.

Behavioral: MIND diet educationBehavioral: Routine follow-up and general advice

Control group

ACTIVE COMPARATOR

Participants in the control group will be routinely followed up and given general advice on healthy lifestyle.

Behavioral: Routine follow-up and general advice

Interventions

MIND diet educationBEHAVIORAL

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).

MIND diet intervention
Routine follow-up and general adviceBEHAVIORAL

Routine follow-up administered by trained staff.

Control groupMIND diet intervention

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310058, China

RECRUITING

Related Publications (4)

  • 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.

    PMID: 37133875BACKGROUND

  • 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.

    PMID: 37105521BACKGROUND

  • 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.

    PMID: 26086182BACKGROUND

  • 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.

    PMID: 33434704BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Changzheng Yuan, ScD

    Zhejiang University

    STUDY CHAIR

Central Study Contacts

Changzheng Yuan, ScD

CONTACT

86-17326860291chy478@zju.edu.cn

Xin Xu, PhD

CONTACT

86-13575760802xuxinsummer@zju.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Single (outcomes assessor)
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 13, 2023

First Posted

August 4, 2023

Study Start

July 26, 2023

Primary Completion

August 1, 2025

Study Completion

August 1, 2025

Last Updated

August 4, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will share

When applicable, electronic data will be made available after trial completion.

Shared Documents
CSR
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).
Access Criteria
Review \& Approval by the Publications and Presentation Committee.

Locations

CN(1)