NCT06605898 Optimized Tailored Interventions in Metabolic and Lifestyle Outcomes (OPTIMAL)

Eligibility & Interventions

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What to Expect as a Participant

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This trial targets 72 participants in total. It began in 2024-07-03 with a primary completion date of 2026-12-31.

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.

Eligibility Criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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

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