A Scalable Nutrition Adherence Intervention
Public ClinicalTrials.gov record NCT06121986. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Scalable Nutrition Intervention to Improve Gut and Brain Health in Underserved Rural Older Adults With and Without Mild Cognitive Impairment
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06121986
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 61 participants
Conditions and interventions
Conditions
Interventions
- Improving Cognitive Aging through Nutrition (ICAN) Adherence Program Behavioral
- Improving Cognitive Aging through Nutrition, Mediterranean diet Behavioral
Behavioral
Eligibility (public fields only)
- Age range
- 55 Years to 85 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 29, 2023
- Primary completion
- Feb 17, 2026
- Completion
- Feb 28, 2026
- Last update posted
- Jun 30, 2026
2023 – 2026
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 2010 Levy Ave - Center for Translational Behavioral Science | Tallahassee | Florida | 32303 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06121986, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 30, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06121986 live on ClinicalTrials.gov.