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NCT Number: NCT06437860

Nutritional Intervention for Sustaining Health (NURISH) Trial

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MIND Diet

Other

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

Control diet

Other

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

Primary outcomes

  1. Attentional Accuracy

    Time frame: 12 weeks (Baseline vs Follow-Up)

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

  2. Attentional Reaction Time

    Time frame: 12 weeks (Baseline vs Follow-Up)

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

  3. Attentional Resource Allocation

    Time frame: 12 weeks (Baseline vs Follow-Up)

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

  4. Attentional Processing Speed

    Time frame: 12 weeks (Baseline vs Follow-Up)

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

  5. Fasting Blood Glucose

    Time frame: 12 weeks (Baseline vs Follow-Up)

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

  6. Fasting Blood Triglycerides

    Time frame: 12 weeks (Baseline vs Follow-Up)

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

  7. Fasting Blood HDL

    Time frame: 12 weeks (Baseline vs Follow-Up)

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

  8. Blood Pressure

    Time frame: 12 weeks (Baseline vs Follow-Up)

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

  9. Waist Circumference

    Time frame: 12 weeks (Baseline vs Follow-Up)

    Changes in waist circumference (cm) between groups.

Secondary outcomes

  1. Macular Pigment Optical Density

    Time frame: 12 weeks (Baseline vs Follow-Up)

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

  2. Visceral Adipose Tissue

    Time frame: 12 weeks (Baseline vs Follow-Up)

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

Study contacts

Contact information is provided by the study sponsor or research team.

Naiman Khan, PhD

CONTACT

[email protected]

217 300 1667

Sponsors and collaborators

Lead sponsor

University of Illinois at Urbana-Champaign

Other

Registry information

Official study 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.

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
May 31, 2024
Registry last updated
May 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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