Optimized Tailored Interventions in Metabolic and Lifestyle Outcomes (OPTIMAL)

Recruiting now · Not applicable

Conditions studied: Cognitive Change, Diet, Healthy, Metabolic Syndrome, Protection Against

In brief

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 facts

Study ID: NCT06605898
Run by: University of Illinois at Urbana-Champaign
People needed: 72
Starts: 2024-07-03
Expected to finish: 2027-12-31
Last updated by the study team: 2024-09-20

Who can join

Age: 45 and older, up to 64. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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.

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

Where it is running

University of Illinois at Urbana-Champaign — Urbana, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

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