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Behavioral Intervention

Nutrition Programs for Cognitive Impairment

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

No Placebo-Only Group

Summary

This trial tests two diets on older adults in rural Black and African-American communities in North Florida. One diet is rich in natural foods, while the other also helps the body burn fat for energy. Researchers want to see if these diets can improve health and brain function.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 10-weeks, 6 months, 12 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Gut Microbial Metabolites

Ketosis (adherence)

Mediterranean Diet (adherence)

Secondary study objectives

Clinical signal of effect

Other study objectives

Blood glucose levels

Mood

Pain and Pain-related disability

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

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

0 / 1Eligibility criteria met