NCT06121986 · ACTIVE NOT RECRUITING
A Scalable Nutrition Adherence Intervention
This trial is testing two diets — the standard Mediterranean diet and a Modified Mediterranean-Ketogenic diet — to see how well people stick to each one and whether either diet improves gut health markers linked to Alzheimer's risk. It focuses on racially diverse rural communities in North Florida. This is a Phase N/A behavioral study, meaning it is testing a real-world program rather than a drug, and results are not yet proven.
You may qualify if
- Ages 55-85
- converted telephone MoCA total score: MCI = 17 ≤ 26, CN= ≥27 and/or and/or MCS MCI≥3, CN\<3
- interest in participating in a nutrition program
- stable medical condition (at least 3 months prior to screening visit) at the discretion of study physician
- stable on medications if any (at least 4 weeks prior to screening visit) at the discretion of study physician
- able to complete the required assessments
You're excluded if
- MoCA ≤ 16, or diagnosis of neurodegenerative illness (except MCI or early AD in the MCI group)
- current evidence or history in the last 1 year of focal brain lesion, head injury with loss of consciousness, or any major psychiatric disorder including psychosis, bipolar disorder, severe major depression (PHQ-9 > 20), alcohol or substance abuse, or disordered eating symptoms (SCOFF > 2)
- sensory impairment (visual or auditory) that might preclude participant from participating in the study
- serious medical risk or organ failure, such as type 1 diabetes mellitus, recent cardiac event (e.g. heart attack, angioplasty)
- prescribed Warfarin, insulin, or immunosuppressants
- use of medications including anticonvulsants, drugs with potential interfering CNS effects (except cholinesterase inhibitors or memantine), and medications with known anticholinergic activity
- a nut or fish allergy (does not include shellfish)
- current use of highly restrictive or specialized diet regimen (e.g., vegan, use of MAOIs etc.)
- major digestive disorders, absorption issues, or surgeries that could be exacerbated by dietary intervention
- Non-English speaking.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-03-11