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ACTIVE NOT RECRUITING NA

A Scalable Nutrition Adherence Intervention

NCT06121986 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • BEHAVIORAL Improving Cognitive Aging through Nutrition (ICAN) Adherence Program
  • BEHAVIORAL Improving Cognitive Aging through Nutrition, Mediterranean diet

Study Locations (1)

Florida

  • 2010 Levy Ave - Center for Translational Behavioral Science — Tallahassee

Trial Details

FieldValue
Enrollment Target 61 participants
Start Date 2023-11-30
Est. Completion 2026-05
Phase NA

Sponsor

Florida State University

291 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06121986

The ClinicalTrials.gov registry entry for NCT06121986 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 61 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Florida State University, which has 291 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Alzheimer Disease appearing as the primary indexed condition, and to 2 interventions — of which Improving Cognitive Aging through Nutrition (ICAN) Adherence Program is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06121986 reports 1 study location spanning 1 distinct geographic area — top geographies include Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06121986 about?

NCT06121986 is a clinical study titled "A Scalable Nutrition Adherence Intervention". 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 th...

What is the current status of trial NCT06121986?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 61 participants. The study started on 2023-11-30. Estimated completion is 2026-05.

What conditions does trial NCT06121986 study?

This clinical trial studies the following conditions: Alzheimer Disease, Mild Cognitive Impairment, Adherence. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06121986?

The interventions under investigation include: Improving Cognitive Aging through Nutrition (ICAN) Adherence Program (BEHAVIORAL), Improving Cognitive Aging through Nutrition, Mediterranean diet (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06121986?

This trial is sponsored by Florida State University, which has 291 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06121986 being conducted?

This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial