Nutritional Intervention for Sustaining Health (NURISH) Trial

Not Applicable

Not yet recruiting

• Conditions: Diet, Healthy; Metabolic Syndrome, Protection Against; Cognitive Change
• Interventions: Other: MIND Diet; Other: Control Diet

• Registration Number: NCT06437860
• Lead Sponsor: University of Illinois at Urbana-Champaign

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.

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-24
• Study First Submitted QC: 2024-05-24
• Last Update Submitted: 2024-05-24
• Study First Posted: 2024-05-31
• Last Update Posted: 2024-05-31
• Study Start: 2024-06-03
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 72

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MIND Diet	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.
Control Diet	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).

Primary Outcome Measures

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

Secondary Outcome Measures

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