Nutrition Programs for Cognitive Impairment

Overseen By Julia L Sheffler, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Florida State University

Must not be taking: Warfarin, Insulin, Immunosuppressants, Anticonvulsants

Disqualifiers: Neurodegenerative illness, Major psychiatric disorder, Serious medical risk, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate adherence to two different nutrition programs and their effects on brain health, particularly concerning Alzheimer's disease. Participants will follow either a Mediterranean diet or a Mediterranean-Ketogenic diet, while researchers examine changes in gut bacteria and other health markers. The trial seeks participants interested in trying a nutrition program who have mild cognitive impairment (early memory and thinking problems) or are older adults without these issues. Individuals with a stable medical condition who are not on a restrictive diet may be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to understanding how diet can impact brain health.

Will I have to stop taking my current medications?

The trial requires that participants be stable on their medications for at least 4 weeks before the screening visit, but it does not specify if you need to stop taking them. However, certain medications like Warfarin, insulin, and some others are not allowed.

Will I have to stop taking my current medications?

The trial requires that participants be stable on their medications for at least 4 weeks before the screening visit, but it does not specify if you need to stop taking them. However, certain medications like Warfarin, insulin, and some others are not allowed.

What prior data suggests that this protocol is safe for participants?

Research has shown that the Mediterranean and ketogenic diets are generally safe and can benefit brain health. Studies have found that both diets might help slow memory and thinking problems. The Mediterranean diet, in particular, is linked to fewer health risks and is easy for most people to follow.

Research on a modified version of the Mediterranean ketogenic diet examined its effects on Alzheimer's disease and suggested possible benefits, such as improved brain function. While side effects like stomach issues can occur, they are usually mild and manageable.

Both diet plans in this trial focus on dietary changes, which are considered safer than medications, resulting in a low chance of serious side effects. However, participants should always consult their doctor before making any diet changes to ensure they are suitable for their health needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Nutrition Programs for Cognitive Impairment trial because it explores using dietary approaches to help cognitive health, which is a fresh angle compared to traditional drug therapies. The trial investigates two unique programs: the Mediterranean Nutrition Adherence Program and the Modified Mediterranean Ketogenic Nutrition Adherence Program. Unlike standard treatments that often rely on medication, these programs focus on dietary changes and group support to enhance cognitive function. By emphasizing nutrition and community support through virtual group meetings, these programs offer a holistic approach that could complement or provide an alternative to conventional treatments for cognitive impairment. This innovative approach could broaden the understanding of how lifestyle changes impact cognitive health.

What evidence suggests that this trial's nutrition programs could be effective for cognitive impairment?

This trial will compare the effects of the Mediterranean diet and the modified Mediterranean ketogenic diet (MKN) on cognitive function. Research has shown that the Mediterranean diet is linked to better brain health and might slow memory and thinking problems. The MKN diet combines the Mediterranean diet with low-carb, high-fat ketogenic principles, potentially enhancing brain function by affecting the gut-brain connection. Earlier research suggests that the MKN diet can positively alter gut bacteria and increase beneficial brain chemicals. These diets have been associated with improved outcomes in individuals with mild memory and thinking issues. ^{2 3 4 5 6}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

If you scored between 17 and 26 on the MoCA test, you may not be able to participate. If you scored 27 or higher, you may be eligible.

I am between 55 and 85 years old.

My medications have been stable for at least 4 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Phone screening

Baseline Assessment

Consented participants undergo baseline assessments including vitals, biometrics, and cognitive tests

2 weeks

1 visit (in-person)

Intervention

Participants engage in a 10-week Mediterranean-Ketogenic nutrition adherence program with weekly group meetings

10 weeks

1 in-person visit, 9 virtual visits

10-week Post-Assessment

Evaluation of adherence and repeat of baseline procedures excluding clinical interview

1 week

1 visit (in-person)

Follow-up

Participants are monitored for long-term adherence and health outcomes at 6 and 12 months

12 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Mediterranean Nutrition Adherence Program
• Modified Mediterranean Ketogenic Nutrition Adherence Program

Trial Overview

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.

How Is the Trial Designed?

Group I: MKN Adherence Program + Maintenance Opt 2 Experimental Treatment 1 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 1 Experimental Treatment 1 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 1 Active Control 1 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 2 Active Control 1 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.

Who Is Running the Clinical Trial?

Florida State University

Lead Sponsor

Trials

234

Recruited

41,100+

Published Research Related to This Trial

In a study of 2830 older adults, an optimal Mediterranean diet adherence score of 4 was identified, indicating that those who adhered to this diet had better cognitive performance and lower inflammatory markers.

Higher levels of white blood cells and neutrophils were linked to poorer cognitive performance in those with low adherence to the Mediterranean diet, while a higher platelet-to-lymphocyte ratio was associated with better cognitive outcomes in those with high adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MedDiet adherence score for the association between inflammatory markers and cognitive performance in the elderly: a study of the NHANES 2011-2014. Liu, S., Chen, X.[2022]

A review of recent randomized controlled trials (RCTs) found that chronic intake of whole foods from Mediterranean, DASH, MIND, and ketogenic diets generally supports improvements in cognitive function, with 26 out of 29 studies showing positive results.

Despite variations in study design and small sample sizes, the evidence suggests that these dietary patterns can be an effective nonpharmacological approach to enhance cognitive health in middle-aged and older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Dietary Intake Through Whole Foods on Cognitive Function: Review of Randomized Controlled Trials. Jiwani, R., Robbins, R., Neri, A., et al.[2022]

In a 3-year study involving 70 cognitively normal participants aged 30 to 60, those with higher adherence to a Mediterranean-style diet (MeDi+) showed significantly better brain health, with lower levels of β-amyloid deposition and better glucose metabolism compared to those with lower adherence (MeDi-).

The findings suggest that higher adherence to the Mediterranean diet may provide 1.5 to 3.5 years of protection against Alzheimer's disease (AD) biomarkers, indicating the potential of dietary interventions in promoting brain health and preventing AD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mediterranean diet and 3-year Alzheimer brain biomarker changes in middle-aged adults. Berti, V., Walters, M., Sterling, J., et al.[2022]

In a study of 140 frail elderly individuals in Northern Italy, a strong adherence to the Mediterranean diet was linked to better cognitive performance, particularly in attention and executive function.

The research suggests that good nutritional status, characterized by a high adherence to the Mediterranean diet, may play a protective role against cognitive decline in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Nutrition on Cognitive Performance in a Frail Elderly Population Living in Northern Italy. Fostinelli, S., Ferrari, C., De Amicis, R., et al.[2023]

In a study of 6,647 older adults with overweight or obesity, higher adherence to the Mediterranean diet was linked to improved cognitive performance over 2 years, particularly in general cognitive screening and executive function tests.

Adherence to the MIND diet also showed positive effects on working memory, while the DASH diet did not demonstrate any significant association with cognitive function changes during the same period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mediterranean, DASH, and MIND Dietary Patterns and Cognitive Function: The 2-Year Longitudinal Changes in an Older Spanish Cohort. Nishi, SK., Babio, N., Gómez-Martínez, C., et al.[2023]

The Mediterranean ketogenic nutrition (MKN) program that included motivational interviewing and behavior change techniques led to higher participant retention (82%) and attendance (91%) compared to a standard education program, indicating it may be more effective in engaging older adults with memory concerns.

Participants in the MKN Adherence program showed better adherence to the diet and some clinical benefits, although these benefits were less pronounced at the 3-month follow-up, suggesting that ongoing support may be necessary for sustained effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Adherence to a Mediterranean Ketogenic Nutrition Program for High-Risk Older Adults: A Pilot Randomized Trial. Sheffler, JL., Kiosses, DN., He, Z., et al.[2023]

A 6-week ketogenic nutrition adherence program was successfully completed by all 9 older adults (ages 64-75) with mild cognitive impairment, showing high adherence and measurable ketone levels in 8 participants.

Significant improvements in cognitive performance were observed, with a median score increase from 88 to 96, indicating potential benefits of the ketogenic diet for cognitive function in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of an MI-CBT ketogenic adherence program for older adults with mild cognitive impairment. Sheffler, JL., Arjmandi, B., Quinn, J., et al.[2022]

In a study of 16,058 women aged 70 and older, long-term adherence to the Mediterranean diet was associated with moderately better cognitive function, as measured by cognitive tests over 6 years.

However, the Mediterranean diet did not show a significant impact on cognitive decline over time, indicating that while it may support better cognitive status, it does not necessarily prevent cognitive deterioration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term adherence to the Mediterranean diet is associated with overall cognitive status, but not cognitive decline, in women. Samieri, C., Okereke, OI., E Devore, E., et al.[2023]

Adherence to the Mediterranean Diet (aMED) was linked to a significantly lower risk of cognitive impairment in a study of 7,756 participants, with odds ratios indicating a strong protective effect against cognitive decline.

Higher fish intake was associated with better cognitive function and a slower rate of cognitive decline over 5 to 10 years, suggesting that specific dietary components may enhance cognitive health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to a Mediterranean diet and cognitive function in the Age-Related Eye Disease Studies 1 & 2. Keenan, TD., Agrón, E., Mares, JA., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10223314/

Improving Adherence to a Mediterranean Ketogenic ...

This pilot trial demonstrated that the MKN program incorporating MI and BCT strategies may better engage and retain participants than a nutrition education ...

2.

mdpi.com

mdpi.com/2075-1729/13/1/173

Mediterranean Diet, Ketogenic Diet or MIND Diet for Aging ...

Previous systematic reviews and meta-analyses provide consistent evidence that MeDi adherence is associated with improved outcomes in cognitive function and ...

3.

nature.com

nature.com/articles/s43856-024-00682-w

Consuming a modified Mediterranean ketogenic diet ...

We investigated the effects of a modified Mediterranean ketogenic diet (MMKD) on the plasma lipidome in the context of AD biomarkers.

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT2984540

Effect of a Modified Ketogenic-Mediterranean Diet on ...

The data collected will help determine changes in cognitive function, brain structure and function, and levels of certain proteins and hormones in body fluids.

5.

thelancet.com

thelancet.com/article/S2352-3964(19)30554-7/fulltext

Modified Mediterranean-ketogenic diet modulates gut ...

The data suggest that specific gut microbial signatures may depict the mild cognitive impairment and that the MMKD can modulate the gut microbiome and ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7231139/

Influence of the Mediterranean and Ketogenic Diets on ...

The aim of the present narrative review is to overview the existing research on the efficacy of MedDi and KD against AD-related cognitive decline.