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MIND Diet and Cognitive Function in Adults With MCI

Primary Purpose

Mild Cognitive Impairment, Cognitive Function, Cognitive Decline

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
MIND diet education
Routine follow-up and general advice
Sponsored by
Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mild Cognitive Impairment

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Zhejiang University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MIND diet intervention

Control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
Change in Montreal Cognitive Assessment (MoCA) score
MoCA will be assessed to determine cognitive change.

Full Information

First Posted
July 13, 2023
Last Updated
August 3, 2023
Sponsor
Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT05975723
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 26, 2023 (Actual)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Cognitive Function, Cognitive Decline

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Single (outcomes assessor)
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MIND diet intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Participants in the control group will be routinely followed up and given general advice on healthy lifestyle.
Intervention Type
Behavioral
Intervention Name(s)
MIND diet education
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Routine follow-up and general advice
Intervention Description
Routine follow-up administered by trained staff.
Primary Outcome Measure Information:
Title
Change in Global Cognition measured by comprehensive Neuropsychological Test Battery (NTB)
Description
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.
Time Frame
Up to one year
Title
Change in Domain-specific Cognition
Description
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.
Time Frame
Up to one year
Secondary Outcome Measure Information:
Title
Change in Clinical Dementia Rating-Sum of Boxes (CDR-SB)
Description
The Clinical Dementia Rating-Sum of Boxes (CDR-SB) is scored from 0 to 18. Higher scores reflect worse performance.
Time Frame
Up to one year
Title
Change in Alzheimer's Disease Cooperative Study Activities of Daily Living Mild Cognitive Impairment-Activities of Daily Living Inventory (ADCS MCI-ADL)
Description
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.
Time Frame
Up to one year
Title
Change in Pittsburgh Sleep Quality Index (PSQI)
Description
The Pittsburgh Sleep Quality Index (PSQI) is scored from 0 to 21. Higher scores indicate worse sleep quality.
Time Frame
Up to one year
Title
Change in Montreal Cognitive Assessment (MoCA) score
Description
MoCA will be assessed to determine cognitive change.
Time Frame
Up to one year
Other Pre-specified Outcome Measures:
Title
Change in dietary behaviour measured using a food frequency questionnaire
Description
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.
Time Frame
Up to one year
Title
Change in depressive status measured using the Geriatric Depression Scale (GDS)
Description
To evaluate the effect on the depressive status of the MIND diet intervention. A higher GDS score indicates more severe depressive symptoms.
Time Frame
Up to one year
Title
Change in anxiety status measured using the General Anxiety Disorder-7 (GAD-7)
Description
To evaluate the effect on the anxiety status of the MIND diet intervention. A higher GAD-7 score indicates more severe anxious symptoms.
Time Frame
Up to one year
Title
Changes in plasma metabolic profiles measured using metabolome analysis
Description
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.
Time Frame
Up to one year
Title
Changes in plasma inflammatory biomarkers
Description
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.
Time Frame
Up to one year
Title
Changes in the intestinal microbiome
Description
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.
Time Frame
Up to one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Changzheng Yuan, ScD
Phone
86-17326860291
Email
chy478@zju.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Xin Xu, PhD
Phone
86-13575760802
Email
xuxinsummer@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Changzheng Yuan, ScD
Organizational Affiliation
Zhejiang University
Official's Role
Study Chair
Facility Information:
Facility Name
Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310058
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Changzheng Yuan, ScD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
37133875
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.
Results Reference
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PubMed Identifier
37105521
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.
Results Reference
background
PubMed Identifier
26086182
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.
Results Reference
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PubMed Identifier
33434704
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.
Results Reference
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MIND Diet and Cognitive Function in Adults With MCI

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