NCT06121986

Brief 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. 1.Have greater evidence of gut dysbiosis at baseline than cognitively normal controls and
  2. 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
61

participants targeted

Target at P25-P50 for not_applicable alzheimer-disease

Timeline
Completed

Started Nov 2023

Typical duration for not_applicable alzheimer-disease

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 8, 2023

Completed
22 days until next milestone

Study Start

First participant enrolled

November 30, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 18, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

2.2 years

First QC Date

October 30, 2023

Last Update Submit

March 9, 2026

Conditions

Alzheimer DiseaseMild Cognitive ImpairmentAdherence

Keywords

Mediterranean dietModified Mediterranean ketogenic dietImproving Cognitive Aging through NutritionICAN

Outcome Measures

Primary Outcomes (3)

  • Ketosis (adherence)

    Participants will show measurable levels of ketones using at-home urinalysis test strips by week 10 of the intervention, as evidenced by small trace amounts of ketones on the urine strips.

    Baseline, 10-weeks, 6 months, 12 months

  • Mediterranean Diet (adherence)

    Participants will show acceptable adherence to a Mediterranean diet by week 10 of the intervention, as shown by an average score of \>6 (moderate) on Mediterranean Diet Adherence Screener (MEDAS) questionnaire. Dietary adherence will also be calculated based on composition of macros and micronutrients using participant food logs.

    Baseline, 10-weeks, 6 months, 12 months

  • Gut Microbial Metabolites

    Participants with MCI will show greater increases in beneficial gut microbial metabolites in response to M-KN and the Mediterranean diet compared to CN controls demonstrating beneficial changes in the gut brain axis.

    Baseline, 10-weeks, 6 months, 12 months

Secondary Outcomes (1)

  • Clinical signal of cognitive effect

    Baseline, 10-weeks, 6 months, 12 months

Other Outcomes (6)

  • Total cholesterol

    Baseline, 10-weeks, 6 months, 12 months

  • Blood glucose levels

    Baseline, 10-weeks, 6 months, 12 months

  • Sleep

    Baseline, 10-weeks, 6 months, 12 months

  • +3 more other outcomes

Study Arms (4)

MMKD ICAN Program + Monthly Support Groups

EXPERIMENTAL

The M-KN adherence program will consist of 10, 1-hour weekly group meetings, which will take place via HIPAA-compliant Zoom. Sessions will be devoted to providing nutrition information, building group support, identifying participant goals, and working as a group to overcome barriers. Participants will be provided with access to ongoing monthly support groups after the 10-week program ends.

Behavioral: Improving Cognitive Aging through Nutrition (ICAN) Adherence Program

Mediterranean ICAN Adherence Program + Monthly Support Groups

ACTIVE COMPARATOR

The Mediterranean ICAN adherence program will consist of 10, 1-hour weekly group meetings, which will primarily take place via HIPAA-compliant Zoom. Sessions will be devoted to providing nutrition information, building group support, identifying participant goals, and working as a group to overcome barriers. Participants will be provided with access to ongoing monthly support groups after the 10-week program ends.

Behavioral: Improving Cognitive Aging through Nutrition, Mediterranean diet

MMKD ICAN Adherence Program + online resources

EXPERIMENTAL

The MMKD ICAN adherence program will consist of 10, 1-hour weekly group meetings, which will take place via HIPAA-compliant Zoom. Sessions will be devoted to providing nutrition information, building group support, identifying participant goals, and working as a group to overcome barriers. Participants will be provided with access to an online forum after the program.

Behavioral: Improving Cognitive Aging through Nutrition (ICAN) Adherence Program

Mediterranean ICAN Adherence Program + Online Resources

ACTIVE COMPARATOR

The Mediterranean ICAN adherence program will consist of 10, 1-hour weekly group meetings, which will take place via HIPAA-compliant Zoom. Sessions will be devoted to providing nutrition information, building group support, identifying participant goals, and working as a group to overcome barriers. Participants will be provided with access to an online forum after the program.

Behavioral: Improving Cognitive Aging through Nutrition, Mediterranean diet

Interventions

Improving Cognitive Aging through Nutrition (ICAN) Adherence ProgramBEHAVIORAL

The ICAN program consists of 10 weekly meetings. The first session occurrs in-person and lasts 90 minutes, and all remaining sessions are 60 minutes and take place via HIPAA-compliant Zoom. The ICAN program is led by two trained facilitators (Bachelor's level or higher facilitators). Sessions are devoted to providing accessible nutrition education, building group support, identifying participant goals, teaching new behavioral and cognitive skills, and working collaboratively to overcome barriers. Information is presented using pre-recorded videos with built-in stop points throughout the sessions for questions and discussion. The program is designed to enhance adherence to a variety of whole-foods based diets by providing a structure that can easily be adapted to to input specialized dietary information. In addition to basic nutrition education, the base ICAN framework also includes modules for managing stress, improving sleep quality, and increasing physical activity.

Also known as: ICAN Program, MMKD
MMKD ICAN Adherence Program + online resourcesMMKD ICAN Program + Monthly Support Groups
Improving Cognitive Aging through Nutrition, Mediterranean dietBEHAVIORAL

The ICAN program consists of 10 weekly meetings. The first session occurrs in-person and lasts 90 minutes, and all remaining sessions are 60 minutes and take place via HIPAA-compliant Zoom. The ICAN program is led by two trained facilitators (Bachelor's level or higher facilitators). Sessions are devoted to providing accessible nutrition education, building group support, identifying participant goals, teaching new behavioral and cognitive skills, and working collaboratively to overcome barriers. Information is presented using pre-recorded videos with built-in stop points throughout the sessions for questions and discussion. The program is designed to enhance adherence to a variety of whole-foods based diets by providing a structure that can easily be adapted to to input specialized dietary information. In addition to basic nutrition education, the base ICAN framework also includes modules for managing stress, improving sleep quality, and increasing physical activity.

Mediterranean ICAN Adherence Program + Monthly Support GroupsMediterranean ICAN Adherence Program + Online Resources

Eligibility Criteria

Age55 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

2010 Levy Ave - Center for Translational Behavioral Science

Tallahassee, Florida, 32303, United States

Location

Related Publications (1)

  • Sheffler JL, Meng Z, Sims T, Caimary VG, Nagpal R, Mompremier G. Facilitators and Barriers to Adherence and Engagement in a Lifestyle Intervention for High-Risk Older Adults: A Multi-Trial Analysis. Nutrients. 2026 Feb 26;18(5):747. doi: 10.3390/nu18050747.

    PMID: 41829915DERIVED

MeSH Terms

Conditions

Alzheimer DiseaseCognitive Dysfunction

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersCognition Disorders

Intervention Hierarchy (Ancestors)

Diet, Plant-BasedDiet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 30, 2023

First Posted

November 8, 2023

Study Start

November 30, 2023

Primary Completion

February 18, 2026

Study Completion

May 1, 2026

Last Updated

March 11, 2026

Record last verified: 2026-03

Locations

US(1)