Optimized Tailored Interventions in Metabolic and Lifestyle Outcomes (OPTIMAL)

Part of paid clinical trials in Urbana, Illinois.

Sponsor
University of Illinois at Urbana-Champaign
Study ID
NCT06605898
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
45 Years - 64 Years
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jul 3, 2024
Status verified
Sep 2024
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
72 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Standard 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. 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.
  • Experimental: Predictive Analytics informed MIND Diet
    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.
  • Active Comparator: 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 Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Illinois at Urbana-ChampaignUrbanaIllinois61801
Naiman A Khan, PhD, RD
[email protected]
2173002197
Naiman A Khan, PhD, RD

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By research site
University of Illinois at Urbana-Champaign· Urbana, IL

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