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Life sciences · Interventional Study
ClinicalTrials.gov · October 5, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT06121986). This is a study registration, not published results. Lead sponsor: Florida State University. Recruitment status: COMPLETED. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 61 participants (ACTUAL). Conditions: Alzheimer Disease, Mild Cognitive Impairment, Adherence. Interventions: BEHAVIORAL: Improving Cognitive Aging through Nutrition (ICAN) Adherence Program; BEHAVIORAL: Improving Cognitive Aging through Nutrition, Mediterranean diet. Primary outcome measures: Ketosis (adherence) , Baseline, 10-weeks, 6 months, 12 months; Mediterranean Diet (adherence) , Baseline, 10-weeks, 6 months, 12 months; Gut Microbial Metabolites , Baseline, 10-weeks, 6 months, 12 months. Brief 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.