Status:
ACTIVE_NOT_RECRUITING
A Scalable Nutrition Adherence Intervention
Lead Sponsor:
Florida State University
Conditions:
Alzheimer Disease
Mild Cognitive Impairment
Eligibility:
All Genders
55-85 years
Phase:
NA
Brief Summary
Objective 1: To scale-up the nutrition adherence intervention for testing in predominantly Black and African-American rural communities in North Florida. The investigators hypothesize that: 1\. The ...
Detailed Description
Recruitment: Throughout years 1 through 3, my team will engage in outreach initiatives to expand on my laboratory's current participant registry to increase numbers of diverse rural adults aged 50+. C...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
November 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2027
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT06121986
Start Date
November 30 2023
End Date
January 1 2027
Last Update
March 12 2025
Active Locations (1)
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1
2010 Levy Ave - Center for Translational Behavioral Science
Tallahassee, Florida, United States, 32303