Nutritional Intervention for Sustaining Health (NURISH) Trial

Cognitive Change Clinical 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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06437860
• Other study ID #: NURISH
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 3, 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: May 2024
• Source: University of Illinois at Urbana-Champaign
• Contact: Naiman Khan, PhD
• Phone: 217 300 1667
• Email: nakhan2[@]illinois.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 72
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• MIND Diet
Daily meals designed to increase adherence to the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) dietary pattern.
• Control Diet
Daily meals designed to increase fruit, vegetable, and whole grain intake consistent with a healthy American diet.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Urbana-Champaign

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Attentional Accuracy	Changes in accuracy (%) between groups using a computerized flanker task.	12 weeks (Baseline vs Follow-Up)
Primary	Attentional Reaction Time	Changes in reaction time (ms) between groups using a computerized flanker task.	12 weeks (Baseline vs Follow-Up)
Primary	Attentional Resource Allocation	Changes in P3 event related potential amplitude (microvolts) between groups using a computerized flanker task.	12 weeks (Baseline vs Follow-Up)
Primary	Attentional Processing Speed	Changes in P3 event related potential latency (ms) between groups using a computerized flanker task.	12 weeks (Baseline vs Follow-Up)
Primary	Fasting Blood Glucose	Changes in fasting blood glucose concentration (mg/dL) between groups.	12 weeks (Baseline vs Follow-Up)
Primary	Fasting Blood Triglycerides	Changes in fasting blood triglyceride concentration (mg/dL) between groups.	12 weeks (Baseline vs Follow-Up)
Primary	Fasting Blood HDL	Changes in fasting blood HDL concentration (mg/dL) between groups.	12 weeks (Baseline vs Follow-Up)
Primary	Blood Pressure	Changes in systolic and diastolic blood pressure (mmHg) between groups.	12 weeks (Baseline vs Follow-Up)
Primary	Waist Circumference	Changes in waist circumference (cm) between groups.	12 weeks (Baseline vs Follow-Up)
Secondary	Macular Pigment Optical Density	Changes in Macular Pigment Optical Density (log units) between groups using a macular densitometer.	12 weeks (Baseline vs Follow-Up)
Secondary	Visceral Adipose Tissue	Changes in visceral adipose tissue (g) between groups using Dual X-ray Absorptiometry.	12 weeks (Baseline vs Follow-Up)