Optimized Tailored Interventions in Metabolic and Lifestyle Outcomes (OPTIMAL)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-64
SponsorUniversity of Illinois at Urbana-Champaign
About this 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. 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Non-consent of participant
Above 64 or below 45 years of age
Vision not 20/20 or corrected
Food allergies or intolerances
Trial design
Design model
Parallel
Treatments tested in this trial
MIND Diet
Other interventionDaily meals designed to increase adherence to the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) dietary pattern.
Control Diet
Other interventionDaily meals designed to increase fruit, vegetable, and whole grain intake consistent with a healthy American diet.
Treatment groups
72 Participants
are divided into 3 treatment groupsGroup A: Standard MIND dietExperimental treatment 1 intervention
Group B: Predictive Analytics informed MIND DietExperimental treatment 1 intervention
Group C: Control DietActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Attentional Accuracy
Changes in accuracy (%) between groups using a computerized flanker task.
Time frame
[Time Frame: 12 weeks (Baseline vs Follow-Up)]2
Attentional Reaction Time
Changes in reaction time (ms) between groups using a computerized flanker task.
Time frame
[Time Frame: 12 weeks (Baseline vs Follow-Up)]3
Attentional Resource Allocation
Changes in P3 event related potential amplitude (microvolts) between groups using a computerized flanker task.
Time frame
[Time Frame: 12 weeks (Baseline vs Follow-Up)]4
Attentional Processing Speed
Changes in P3 event related potential latency (ms) between groups using a computerized flanker task.
Time frame
[Time Frame: 12 weeks (Baseline vs Follow-Up)]Secondary outcomes
1
Macular Pigment Optical Density
Changes in Macular Pigment Optical Density (log units) between groups using a macular densitometer.
Time frame
[Time Frame: 12 weeks (Baseline vs Follow-Up)]2
Visceral Adipose Tissue
Changes in visceral adipose tissue (g) between groups using Dual X-ray Absorptiometry.
Time frame
[Time Frame: 12 weeks (Baseline vs Follow-Up)]Sponsors and contacts
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Source ClinicalTrials.gov