NCT06605898 · University of Illinois at Urbana-Champaign
Optimized Tailored Interventions in Metabolic and Lifestyle Outcomes (OPTIMAL)
What this study is about
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.
View original scientific description
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.
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.
Primary outcome measures
Attentional Accuracy
Time frame: [Time Frame: 12 weeks (Baseline vs Follow-Up)]
Changes in accuracy (%) between groups using a computerized flanker task.
Attentional Reaction Time
Time frame: [Time Frame: 12 weeks (Baseline vs Follow-Up)]
Changes in reaction time (ms) between groups using a computerized flanker task.
Attentional Resource Allocation
Time frame: [Time Frame: 12 weeks (Baseline vs Follow-Up)]
Changes in P3 event related potential amplitude (microvolts) between groups using a computerized flanker task.
Attentional Processing Speed
Time frame: [Time Frame: 12 weeks (Baseline vs Follow-Up)]
Changes in P3 event related potential latency (ms) between groups using a computerized flanker task.
Fasting Blood Glucose
Time frame: [Time Frame: 12 weeks (Baseline vs Follow-Up)]
Changes in fasting blood glucose concentration (mg/dL) between groups.
Fasting Blood Triglycerides
Time frame: [Time Frame: 12 weeks (Baseline vs Follow-Up)]
Changes in fasting blood triglyceride concentration (mg/dL) between groups.
Fasting Blood HDL
Time frame: [Time Frame: 12 weeks (Baseline vs Follow-Up)]
Changes in fasting blood HDL concentration (mg/dL) between groups.
Blood Pressure
Time frame: [Time Frame: 12 weeks (Baseline vs Follow-Up)]
Changes in systolic and diastolic blood pressure (mmHg) between groups
Waist Circumference
Time frame: [Time Frame: 12 weeks (Baseline vs Follow-Up)]
Changes in waist circumference (cm) between groups.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Urbana, Illinois
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 20, 2024 · Source of record for eligibility and locations