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Diet study aims to boost brain health in rural seniors

NCT ID NCT06121986

Disease control Sponsor: Florida State University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 2 times

Summary

This study tests a 10-week nutrition program in 61 older adults (ages 55-85) from rural North Florida, some with mild cognitive impairment and some without. Participants follow either a Mediterranean diet or a modified Mediterranean-ketogenic diet. The goal is to see if the program improves gut health and brain function, and whether it can be scaled up for wider use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Modified Mediterranean-Ketogenic diet and Mediterranean diet
What this could lead to
If successful, this could show that a simple nutrition program helps support brain health and slow cognitive decline in older adults.
What could go wrong
This is a small, early-stage study with only 61 participants, so results may not apply widely. It focuses on adherence and gut markers, not yet on proven cognitive benefits.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

61 people

The number who actually took part.

Started

Nov 2023

Finished

Mar 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

55 to 85 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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) * prescribed Warfarin, insulin, or immunosuppressants * use of medications including anticonvulsants, drugs with potential interfering CNS effects (except cholinesterase inhibitors or memantine), and medications with known anticholinergic activity * a nut or fish allergy (does not include shellfish) * current use of highly restrictive or specialized diet regimen (e.g., vegan, use of MAOIs etc.) * major digestive disorders, absorption issues, or surgeries that could be exacerbated by dietary intervention * Non-English speaking.

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Conditions

The condition(s) this trial relates to.

Alzheimer disease Cognitive Dysfunction

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adherence Alzheimer disease Mild cognitive impairment

Contacts and locations

Locations

  • 2010 Levy Ave - Center for Translational Behavioral Science

    Tallahassee, Florida, 32303, United States

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