Nutritional Intervention for Sustaining Health (NURISH) Trial

NCT06437860 | Not Yet Recruiting

• 1 other identifier: NURISH
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cognitive Change; Metabolic Syndrome, Protection Against; Diet, Healthy

Keywords

Executive function; MIND; Dietary pattern

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (2)

• Macular Pigment Optical Density

  12 weeks (Baseline vs Follow-Up)

• Visceral Adipose Tissue

  12 weeks (Baseline vs Follow-Up)

Study Arms (2)

MIND Diet

EXPERIMENTAL

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

Control Diet

ACTIVE COMPARATOR

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

Interventions

MIND Diet OTHER

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

MIND Diet

Control Diet OTHER

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

Control Diet

Eligibility Criteria

• Age: 45 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years of age
• /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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Urbana-Champaign: lead

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Naiman Khan, PhD

  University of Illinois Urbana-Champaign

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Naiman Khan, PhD

CONTACT

217 300 1667; nakhan2@illinois.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 24, 2024
• First Posted: May 31, 2024
• Study Start: June 3, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share