Nutritional Intervention for Sustaining Health (NURISH) Trial

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cognitive Change; Diet, Healthy; Metabolic Syndrome, Protection Against
• Intervention / Treatment: Other: MIND Diet; Other: Control Diet

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.

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Naiman Khan, PhD; Phone Number: 217 300 1667; Email: nakhan2@illinois.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MIND Diet; 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.	Other: MIND Diet; Daily meals designed to increase adherence to the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) dietary pattern.
Active Comparator: Control Diet; 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).	Other: Control Diet; Daily meals designed to increase fruit, vegetable, and whole grain intake consistent with a healthy American diet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attentional Accuracy	Changes in accuracy (%) between groups using a computerized flanker task.	12 weeks (Baseline vs Follow-Up)
Attentional Reaction Time	Changes in reaction time (ms) between groups using a computerized flanker task.	12 weeks (Baseline vs Follow-Up)
Attentional Resource Allocation	Changes in P3 event related potential amplitude (microvolts) between groups using a computerized flanker task.	12 weeks (Baseline vs Follow-Up)
Attentional Processing Speed	Changes in P3 event related potential latency (ms) between groups using a computerized flanker task.	12 weeks (Baseline vs Follow-Up)
Fasting Blood Glucose	Changes in fasting blood glucose concentration (mg/dL) between groups.	12 weeks (Baseline vs Follow-Up)
Fasting Blood Triglycerides	Changes in fasting blood triglyceride concentration (mg/dL) between groups.	12 weeks (Baseline vs Follow-Up)
Fasting Blood HDL	Changes in fasting blood HDL concentration (mg/dL) between groups.	12 weeks (Baseline vs Follow-Up)
Blood Pressure	Changes in systolic and diastolic blood pressure (mmHg) between groups.	12 weeks (Baseline vs Follow-Up)
Waist Circumference	Changes in waist circumference (cm) between groups.	12 weeks (Baseline vs Follow-Up)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Macular Pigment Optical Density	Changes in Macular Pigment Optical Density (log units) between groups using a macular densitometer.	12 weeks (Baseline vs Follow-Up)
Visceral Adipose Tissue	Changes in visceral adipose tissue (g) between groups using Dual X-ray Absorptiometry.	12 weeks (Baseline vs Follow-Up)

Collaborators and Investigators

• Sponsor: University of Illinois at Urbana-Champaign
• Investigators: Principal Investigator: Naiman Khan, PhD, University of Illinois Urbana-Champaign

Study record dates

Study Major Dates

• Study Start (Estimated): June 3, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: May 24, 2024
• First Submitted That Met QC Criteria: May 24, 2024
• First Posted (Actual): May 31, 2024

Study Record Updates

• Last Update Posted (Actual): May 31, 2024
• Last Update Submitted That Met QC Criteria: May 24, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: MIND; Executive function; Dietary pattern
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Metabolic Syndrome
• Other Study ID Numbers: NURISH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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