No phaseCompleted

A Scalable Nutrition Adherence Intervention

A Scalable Nutrition Intervention to Improve Gut and Brain Health in Underserved Rural Older Adults With and Without Mild Cognitive Impairment

Sponsor
Florida State University (Academic or other)
Enrolment
61 enrolled
Conditions
Alzheimer Disease; Mild Cognitive Impairment; Adherence
Interventions
Improving Cognitive Aging through Nutrition (ICAN) Adherence Program; Improving Cognitive Aging through Nutrition, Mediterranean diet
Ages
adults, older adults
Registry
NCT06121986

From the registry

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…

Primary outcomes

  • Ketosis (adherence)
  • Mediterranean Diet (adherence)
  • Gut Microbial Metabolites
Full record on ClinicalTrials.gov