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Completed
NCT06121986
A Scalable Nutrition Adherence Intervention
Conditions: Alzheimer Disease, Mild Cognitive Impairment, Adherence
Sex: All
Ages: 55 Years – 85 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 61
Sponsor: Florida State University
Location: 2010 Levy Ave - Center for Translational Behavioral Science Tallahassee Florida
Summary
Objective 1: To scale-up the nutrition adherence intervention for testing in racially diverse rural communities in North Florida.
The investigators hypothesize that:
1\. The protocol will produce at least 75% of participants obtaining measurable levels of urine ketones (e.g., good adherence) in the Modified Mediterranean-Ketogenic diet (MMKD) group and an average score of \>6 on the MEDAS questionnaire in the Mediterranean group during the 10-week program. Further, we hypothesize that the use of ongoing monthly support groups will bolster long-term adherence.
Objective 2: To evaluate the effects of adherence to Mediterranean versus MMKD on novel gut-brain axis markers of Alzheimer's disease pathogenesis in individuals with mild cognitive impairment compared to cognitively normal older adults.
The investigators hypothesize that individuals with mild cognitive impairment will:
1. Have greater evidence of gut dysbiosis at baseline than cognitively normal controls and
2. Will demonstrate greater increases in beneficial gut microbial metabolites in response to adherence to Mediterranean-Ketogenic nutrition and the Mediterranean diet compared to CN controls.
Eligibility Criteria
Inclusion Criteria:
* Ages 55-85
* converted telephone MoCA total score: MCI = 17 ≤ 26, CN= ≥27 and/or and/or MCS MCI≥3, CN\ 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.
Source: ClinicalTrials.gov (NCT06121986). StuddyBuddy aggregates publicly available trial information.