## Protocol Section
### Identification Module
**NCT ID:** NCT06417749

**Brief Title:** MIND Diet and Cognitive Function in Middle-aged and Older Adults

**Official Title:** MIND Diet and Cognitive Function in Middle-aged and Older Adults

#### Organization Study ID Info
**ID:** LL20240353
#### Organization
**Class:** OTHER
**Full Name:** Zhejiang University
### Status Module
#### Completion Date
**Date:** 2025-10-10

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-12

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-05-10

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-10

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-12
**Study First Submit QC Date:** 2024-05-12
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Shandong University

#### Lead Sponsor

**Class:** OTHER

**Name:** Zhejiang University

#### Responsible Party

**Investigator Affiliation:** Zhejiang University

**Investigator Full Name:** Changzheng Yuan

**Investigator Title:** Research Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** A 12-month cluster-randomized controlled trial designed to test the effect of the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet education on the rate of cognitive change and several other secondary outcomes in 1200 adults aged 40-69 years.

**Detailed Description:** Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) Diet and Cognitive Decline in Middle-aged and Elderly People is a 12-month cluster-randomized controlled trial designed to test the effect of the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet education on the rate of cognitive change and several other secondary outcomes in 1200 adults aged 40-69 years. The proposed MIND diet for this study is a hybrid of the Mediterranean and DASH diets but with selected modifications based on the most compelling evidence in the diet-dementia field and Chinese Dietary Guidelines 2022. Specifically, the proposed MIND diet education will emphasize the consumption of whole grains, dark green leafy vegetables, dark red/yellow vegetables, other vegetables, berries and citrus, poultry, fish and seafood, beans and legumes, nuts, olive and seed oils, and green tea, and restrict red and processed meats, animal fat, fried foods, and sweets and pastries. The trial will employ a cluster randomization design comparing the effects on cognitive change of the MIND intervention diet education among 1200 adults aged 40-69 years. Secondary outcomes will include dietary behavior changes, health status changes, etc. The proposed study is sited at Taian, Shandong, China.

### Conditions Module

**Conditions:**

- Cognitive Function

- Dementia

**Keywords:**

- Cognitive Function

- Dietary Pattern

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** This is a two-arm parallel design, with one arm being the control arm and the other being the intervention arm (MIND diet education and food supply).

##### Masking Info

**Masking:** SINGLE

**Masking Description:** This is a single-blind design, where the outcome assessors will be masked from the assignment of the participants.

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 1200

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** General dietary advice

**Intervention Names:**

- Behavioral: Control arm

**Label:** Control arm

**Type:** PLACEBO_COMPARATOR

#### Arm Group 2

**Description:** MIND diet education

**Intervention Names:**

- Behavioral: Intervention arm

**Label:** Intervention arm

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Control arm

**Description:** Participants will receive a copy of the Chinese Dietary Guidelines leaflet at baseline.

**Name:** Control arm

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Intervention arm

**Description:** Participants will be given three MIND diet education videos on different topics at baseline and during follow-up. In addition, each participant will receive a MIND diet education brochure at baseline and some food supply during follow-up.

**Name:** Intervention arm

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** Cognitive function will be assessed using the MoCA at baseline and during follow-up.

**Measure:** Change in 5-min Montreal Cognitive Assessment (MoCA) score

**Time Frame:** 12 months

#### Secondary Outcomes

**Description:** The 5-level EQ-5D (EQ-5D-5L) will be used to assess life quality. Evaluations will be conducted at baseline and during follow-up.

**Measure:** Change in EuroQol Five Dimensions (EQ-5D) scale

**Time Frame:** 12 months

**Description:** AD-8 will be used to assess cognitive function. Evaluations will be conducted at baseline and during follow-up.

**Measure:** Change in 8-Item Alzheimer's Diseases Screening Tool (AD-8) score

**Time Frame:** 12 months

**Description:** Dietary behavior will be assessed using food frequency questionnaire (FFQ). A 15-point MIND diet score will be calculated to reflect the MIND diet adherence among both groups of participants. Evaluations will be conducted at baseline and during follow-up.

**Measure:** Change in Mediterranean-Dietary Approach to Stop Hypertension (DASH) Intervention for Neurodegenerative Delay (MIND) diet score

**Time Frame:** 12 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Normal chewing function, able to eat hard foods such as nuts.
* Willing to participate and sign an informed consent form.
* Able to understand research procedures and adhere to them throughout the entire study period.

Exclusion Criteria:

* Participation in or have participated in other clinical trial studies within the past year.
* Medication to treat Alzheimer's or Parkinson's disease.
* Diagnosis of severe chronic diseases, such as cancer.

**Healthy Volunteers:** True

**Maximum Age:** 69 Years

**Minimum Age:** 40 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Taian

**Contacts:**

***Contact 1:***

- **Email:** chy478@zju.edu.cn

- **Name:** Changzheng Yuan, ScD

- **Phone:** (86)17326860291

- **Role:** CONTACT

***Contact 2:***

- **Name:** Changzheng Yuan, ScD

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 3:***

- **Name:** Tao Zhang, PhD

- **Role:** SUB_INVESTIGATOR

**Country:** China

**Facility:** Mutiple Counties

**State:** Shandong

**Zip:** 271000

### IPD Sharing Statement Module

**Description:** Interested collaborators may put in a request.

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000019965

- Term: Neurocognitive Disorders

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M6904

- Name: Dementia

- Relevance: HIGH

- As Found: Dementia

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M21836

- Name: Neurocognitive Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003704

- Term: Dementia

### Misc Info Module

- Version Holder: 2024-05-31
