A Scalable Nutrition Adherence Intervention

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.

Conditions

• Alzheimer Disease
• Mild Cognitive Impairment
• Adherence

Interventions

BEHAVIORAL

Improving Cognitive Aging through Nutrition (ICAN) Adherence Program

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.

BEHAVIORAL

Improving Cognitive Aging through Nutrition, Mediterranean diet

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.

Sponsors & Collaborators

• Florida Department of Health, Ed and Ethel Moore Alzheimer's Disease Research Program

  collaborator UNKNOWN

• Florida State University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

FACTORIAL

Eligibility

Min Age

55 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-11-30

Primary Completion

2026-02-18

Completion

2026-05-31

Countries

• United States

Study Locations