Optimized Tailored Interventions in Metabolic and Lifestyle Outcomes (OPTIMAL)

NCT06605898 | Recruiting

• 1 other identifier: OPTIMAL
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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. Our research team will evaluate three different groups: the first group will be chosen using a predictive analytics model that predicts who will benefit most from the MIND diet, the second group will follow the MIND diet without being pre-selected, and the third group will eat a standard healthy diet to serve as a comparison. The main questions it aims to answer are: Does the MIND diet improve cognitive performance and heart health relative to a control diet? How does the health impact of the MIND diet in participants pre-identified through predictive analytics compare to those without such pre-selection? Which of the three groups - predictive analytics selected MIND diet group, standard MIND diet group, or healthy control - demonstrate the most significant improvements in cognitive and cardiovascular health over the course of the trial? 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; Diet, Healthy; Metabolic Syndrome, Protection Against

Keywords

Executive function; MIND; Dietary Pattern

Outcome Measures

Primary Outcomes (9)

• Attentional Accuracy

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

  [Time Frame: 12 weeks (Baseline vs Follow-Up)]

• Attentional Reaction Time

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

  [Time Frame: 12 weeks (Baseline vs Follow-Up)]

• Attentional Resource Allocation

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

  [Time Frame: 12 weeks (Baseline vs Follow-Up)]

• Attentional Processing Speed

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

  [Time Frame: 12 weeks (Baseline vs Follow-Up)]

• Fasting Blood Glucose

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

  [Time Frame: 12 weeks (Baseline vs Follow-Up)]

• Fasting Blood Triglycerides

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

  [Time Frame: 12 weeks (Baseline vs Follow-Up)]

• Fasting Blood HDL

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

  [Time Frame: 12 weeks (Baseline vs Follow-Up)]

• Blood Pressure

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

  [Time Frame: 12 weeks (Baseline vs Follow-Up)]

• Waist Circumference

  Changes in waist circumference (cm) between groups.

  [Time Frame: 12 weeks (Baseline vs Follow-Up)]

Secondary Outcomes (2)

• Macular Pigment Optical Density

  [Time Frame: 12 weeks (Baseline vs Follow-Up)]

• Visceral Adipose Tissue

  [Time Frame: 12 weeks (Baseline vs Follow-Up)]

Study Arms (3)

Standard 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. This will be a standard treatment arm without prior selection through predictive analytics. 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

Predictive Analytics informed MIND Diet

EXPERIMENTAL

Participants in the active MIND diet group informed by predictive analytics will be pre-identified based on the results of a machine learning model that predicts who will most likely benefit from the MIND diet. The participants in this 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.

Predictive Analytics informed MIND Diet; Standard 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

Study Sites (1)

University of Illinois at Urbana-Champaign

Urbana, Illinois, 61801, United States

RECRUITING

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

2173001667; 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: September 18, 2024
• First Posted: September 20, 2024
• Study Start: July 3, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 20, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)