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New treatment option for Cognitive Change
Official title Optimized Tailored Interventions in Metabolic and Lifestyle Outcomes (OPTIMAL)
ClinicalTrials.gov ID: NCT06605898
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 64. Healthy volunteers may be eligible.
You may be able to join 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
You likely can't join 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
See the full eligibility 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...
- 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.
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Urbana, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years to 64 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Urbana, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.