← Back to Search

Behavioral Intervention

MKN Adherence Program + Maintenance Opt 2 for Alzheimer's Disease

N/A
Recruiting
Research Sponsored by Florida State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ages 55-85
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 10-weeks, 6 months, 12 months
Awards & highlights

Study Summary

This trial aims to test a nutrition adherence intervention in rural communities in North Florida. The researchers believe that the intervention will lead to good adherence and improved scores on a questionnaire for participants in the Mediterranean-Ket

Who is the study for?
This trial is for adults aged 55-85 with mild cognitive impairment or early Alzheimer's, who are interested in a nutrition program. They should have stable health and medication use for some time before the study starts. The trial focuses on Black and African-American communities in rural North Florida.Check my eligibility
What is being tested?
The study tests two diets: a Mediterranean diet and a modified ketogenic version of it, to see which one better adheres to participants' lifestyles. It also looks at how these diets affect gut-brain markers related to Alzheimer's disease over a 10-week period.See study design
What are the potential side effects?
While not explicitly listed, potential side effects may include digestive changes due to new dietary habits, such as bloating or discomfort. Adherence might also influence energy levels and overall well-being.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 55 and 85 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 10-weeks, 6 months, 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 10-weeks, 6 months, 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Gut Microbial Metabolites
Ketosis (adherence)
Mediterranean Diet (adherence)
Secondary outcome measures
Clinical signal of effect
Other outcome measures
Blood glucose levels
Mood
Pain and Pain-related disability
+3 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: MKN Adherence Program + Maintenance Opt 2Experimental Treatment1 Intervention
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 an online forum after the program.
Group II: MKN Adherence Program + Maintenance Opt 1Experimental Treatment1 Intervention
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 and/or continued use of an online forum after the program.
Group III: Mediterranean Adherence Program + Maintenance Opt 1Active Control1 Intervention
The Mediterranean 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 and/or continued use of an online forum after the program.
Group IV: Mediterranean Adherence Program + Maintenance Opt 2Active Control1 Intervention
The Mediterranean 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.

Find a Location

Who is running the clinical trial?

Florida State UniversityLead Sponsor
200 Previous Clinical Trials
31,694 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of participants being admitted into this clinical study?

"Indeed, the information provided on clinicaltrials.gov confirms that this study is actively seeking participants. The trial was initially posted on November 30th, 2023 and underwent its most recent revision on January 10th, 2024. There are currently enrolling up to 64 patients at a single designated site for this trial."

Answered by AI

Is this medical study actively seeking participants at the moment?

"Indeed, according to the information provided on clinicaltrials.gov, this study is currently seeking eligible participants. The initial posting of the trial occurred on November 30th, 2023, and it was last updated on January 10th, 2024."

Answered by AI

Do I meet the requirements to participate in this clinical study?

"This clinical investigation aims to enroll 64 individuals, aged between 55 and 85 years old, who have mild cognitive impairment. Prospective participants must express a willingness to take part in a nutrition program. Additionally, they should meet the following criteria: having converted telephone MoCA total score within the range of 17-26 for MCI or ≥27 for CN; maintaining a stable medical condition as determined by the study physician at least three months prior to the screening visit; being on stable medication regimen (if applicable) with no changes made at least four weeks before the screening visit according to the discretion of the study physician; and demonstrating capability"

Answered by AI

Is the enrollment for this medical study open to individuals below the age of 30?

"As per the study's eligibility requirements, individuals must be between 55 and 85 years old to participate in this trial."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Scalable Nutrition Adherence Intervention
Julia Sheffler 2023. "A Scalable Nutrition Adherence Intervention". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06121986.
~43 spots leftby Jan 2027
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top