NCT06121986Completed

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

Source: ClinicalTrials.gov · Last updated 5 Oct 2026

Brief summary (registry, in English)

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.

Status (registry): Completed
Study type: Interventional
Enrollment: 61 (actual)
First submitted: 30 Oct 2023
Start date: 30 Nov 2023
Primary completion date: 18 Feb 2026
Lead sponsor: Florida State University
Diseases: Alzheimer disease
NCT number: NCT06121986

What you commit to

Study type: Interventional
Participants enrolled: 61
From 30 Nov 2023 to the primary completion date, 18 Feb 2026
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

use of medications including anticonvulsants, drugs with potential interfering CNS effects (except cholinesterase inhibitors or memantine), and medications with known anticholinergic activity

Other illness

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)
a nut or fish allergy (does not include shellfish)
major digestive disorders, absorption issues, or surgeries that could be exacerbated by dietary intervention

Other

prescribed Warfarin, insulin, or immunosuppressants
current use of highly restrictive or specialized diet regimen (e.g., vegan, use of MAOIs etc.)
Non-English speaking.

Who the study is looking for

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

Age in the registry: 55 years to 85 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
2010 Levy Ave - Center for Translational Behavioral Science Coordinator of this site? Confirm its status	Tallahassee	United States	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.