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Optimized Tailored Interventions in Metabolic and Lifestyle Outcomes (OPTIMAL)

NCT06605898 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2024-09-20

No results posted yet for this study

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

Interventions

OTHER

MIND Diet

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

OTHER

Control Diet

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

Sponsors & Collaborators

  • University of Illinois at Urbana-Champaign

    lead OTHER

Principal Investigators

  • Naiman Khan, PhD · University of Illinois Urbana-Champaign

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-03
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06605898 on ClinicalTrials.gov