## Protocol Section
### Identification Module
**NCT ID:** NCT06437860

**Brief Title:** Nutritional Intervention for Sustaining Health (NURISH) Trial

**Official Title:** Nutritional Intervention for Sustaining Health (NURISH) Trial: Examining the Effects of the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) on Cognitive Performance, Metabolic Health, and Nutrient Status.

#### Organization Study ID Info
**ID:** NURISH
#### Organization
**Class:** OTHER
**Full Name:** University of Illinois at Urbana-Champaign
### Status Module
#### Completion Date
**Date:** 2027-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-24

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-03

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Illinois at Urbana-Champaign

#### Responsible Party

**Investigator Affiliation:** University of Illinois at Urbana-Champaign

**Investigator Full Name:** Naiman Khan

**Investigator Title:** Associate Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The goal of this clinical trial is to learn if increasing adherence to a Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet pattern improves brain and heart health relative to a healthy control diet in middle-aged adults.The main questions it aims to answer are:

Does the MIND diet improve cognitive performance and heart health relative to a control diet?

Researchers will compare the MIND diet group to a control (a healthy diet that does not match the MIND diet) to see if the MIND provides more benefit to health.

Participants will:

Consume one meal that follows the MIND diet or a control meal every day for 3 months Visit the lab before and after the 3 months of meals for tests. Keep a record of the food they eat during the study.

**Detailed Description:** The purpose of this study is to understand how a healthy diet is related to thinking ability and heart health. Participants will be asked to consume a microwaveable study meal or prepackaged smoothie every day for 12 weeks. These meals will be delivered to participant homes using Daily Harvest meal delivery service. The study meals and smoothies will follow either a dietary pattern thought to improve brain and heart health (MIND), or a control diet, and will include foods commonly found in grocery stores. Participants will not know which diet they are assigned to (active or control). Participants will also be asked to follow simple dietary guidance on a healthy diet in addition to the meals provided. Participants will complete a series of online forms or surveys. Additionally, participants will come to 4 in-person laboratory visits to complete several computer-based tests of memory and attention while wearing an EEG cap. Participants will also be asked to complete an eye test, a heart rate and blood pressure assessment, a bone and body scan called DXA, and a blood draw at the beginning of the study and again at the end of the 12-week diet period.

### Conditions Module

**Conditions:**

- Cognitive Change

- Metabolic Syndrome, Protection Against

- Diet, Healthy

**Keywords:**

- Executive function

- MIND

- Dietary pattern

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 72

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants in the active MIND diet group will be asked to consume one ready-to-eat meal per day from Daily Harvest® meal delivery service. The treatment meals will follow MIND diet guidelines and include leafy green vegetables, nuts, legumes, whole grains, berries, and extra virgin olive oil.

**Intervention Names:**

- Other: MIND Diet

**Label:** MIND Diet

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Participants in the control diet group will be asked to consume one ready-to-eat meal per day from Daily Harvest® meal delivery service. The Control group will receive daily meals that are isocaloric with the active/experimental meals but will follow a general diet based on the average American diet and Dietary Guidelines for Americans (i.e., vegetables, fruits, nuts, whole grains, and unsaturated fats).

**Intervention Names:**

- Other: Control Diet

**Label:** Control Diet

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- MIND Diet

**Description:** Daily meals designed to increase adherence to the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) dietary pattern.

**Name:** MIND Diet

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Control Diet

**Description:** Daily meals designed to increase fruit, vegetable, and whole grain intake consistent with a healthy American diet.

**Name:** Control Diet

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Changes in accuracy (%) between groups using a computerized flanker task.

**Measure:** Attentional Accuracy

**Time Frame:** 12 weeks (Baseline vs Follow-Up)

**Description:** Changes in reaction time (ms) between groups using a computerized flanker task.

**Measure:** Attentional Reaction Time

**Time Frame:** 12 weeks (Baseline vs Follow-Up)

**Description:** Changes in P3 event related potential amplitude (microvolts) between groups using a computerized flanker task.

**Measure:** Attentional Resource Allocation

**Time Frame:** 12 weeks (Baseline vs Follow-Up)

**Description:** Changes in P3 event related potential latency (ms) between groups using a computerized flanker task.

**Measure:** Attentional Processing Speed

**Time Frame:** 12 weeks (Baseline vs Follow-Up)

**Description:** Changes in fasting blood glucose concentration (mg/dL) between groups.

**Measure:** Fasting Blood Glucose

**Time Frame:** 12 weeks (Baseline vs Follow-Up)

**Description:** Changes in fasting blood triglyceride concentration (mg/dL) between groups.

**Measure:** Fasting Blood Triglycerides

**Time Frame:** 12 weeks (Baseline vs Follow-Up)

**Description:** Changes in fasting blood HDL concentration (mg/dL) between groups.

**Measure:** Fasting Blood HDL

**Time Frame:** 12 weeks (Baseline vs Follow-Up)

**Description:** Changes in systolic and diastolic blood pressure (mmHg) between groups.

**Measure:** Blood Pressure

**Time Frame:** 12 weeks (Baseline vs Follow-Up)

**Description:** Changes in waist circumference (cm) between groups.

**Measure:** Waist Circumference

**Time Frame:** 12 weeks (Baseline vs Follow-Up)

#### Secondary Outcomes

**Description:** Changes in Macular Pigment Optical Density (log units) between groups using a macular densitometer.

**Measure:** Macular Pigment Optical Density

**Time Frame:** 12 weeks (Baseline vs Follow-Up)

**Description:** Changes in visceral adipose tissue (g) between groups using Dual X-ray Absorptiometry.

**Measure:** Visceral Adipose Tissue

**Time Frame:** 12 weeks (Baseline vs Follow-Up)

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 45-64 years of age
* 20/20 or corrected vision
* No food allergies or intolerances
* Not pregnant, lactating, or have given birth in the past 12 months
* Do not smoke, use tobacco, or abuse drugs
* Absence of liver or gastrointestinal diseases (i.e., primary biliary cirrhosis or gallbladder disease, chronic constipation, diarrhea, Crohn's disease, celiac disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers), hepatitis, HIV, and cancer
* Not currently taking oral hypoglycemic agents, or insulin
* No history of malabsorptive or bariatric surgery
* Cognitively intact with no prior diagnosis of neurological disease (i.e., mild cognitive impairment, Alzheimer's disease, vascular dementia, and/or Asperger's syndrome)
* Able to consume the study meals
* Not enrolled in another dietary, exercise, or medication study during the study

Exclusion Criteria:

* Non-consent of participant
* Above 64 or below 45 years of age
* Vision not 20/20 or corrected
* Food allergies or intolerances
* Pregnant, lactating, or have given birth in the past 12 months
* Smoke, use tobacco, or abuse drugs
* Prior diagnosis of liver or gastrointestinal disease (i.e., primary biliary cirrhosis or gallbladder disease, chronic constipation, diarrhea, Crohn's disease, celiac disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers), hepatitis, HIV, or cancer
* Currently taking oral hypoglycemic agents or insulin
* History of malabsorptive or bariatric surgery
* Cognitively impaired and/or prior diagnosis of neurological disease (i.e., mild cognitive impairment, Alzheimer's disease, vascular dementia, and/or Asperger's syndrome)
* Unable to consume the study meals
* Concurrent enrollment in another dietary, exercise, or medication study

**Healthy Volunteers:** True

**Maximum Age:** 64 Years

**Minimum Age:** 45 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** nakhan2@illinois.edu

**Name:** Naiman Khan, PhD

**Phone:** 217 300 1667

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** University of Illinois Urbana-Champaign

**Name:** Naiman Khan, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007333

- Term: Insulin Resistance

- ID: D000006946

- Term: Hyperinsulinism

- ID: D000044882

- Term: Glucose Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M23005

- Name: Metabolic Syndrome

- Relevance: HIGH

- As Found: Metabolic Syndrome

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M10370

- Name: Insulin Resistance

- Relevance: LOW

- As Found: Unknown

- ID: M9997

- Name: Hyperinsulinism

- Relevance: LOW

- As Found: Unknown

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25403

- Name: Glucose Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000024821

- Term: Metabolic Syndrome

### Intervention Browse Module - Browse Branches

- Abbrev: HB

- Name: Herbal and Botanical

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: T242

- Name: Olive

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
