Intermittent Fasting for Alzheimer's Disease

(TREAD Trial)

Recruiting at 1 trial location

Overseen By Geetika Chahal, MBBS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: St. Joseph's Hospital and Medical Center, Phoenix

Disqualifiers: Diabetes, Eating disorder, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether time-restricted eating, or intermittent fasting, can enhance cognitive function and metabolic health in individuals with mild cognitive impairment (MCI). Participants will fast for 16 hours and eat during an 8-hour window, five days a week, for three months. The trial aims to determine if this eating schedule is both feasible and beneficial for brain health. Ideal participants are adults with MCI who can use the internet and have a family member or friend to assist them. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research on dietary impacts on brain health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that time-restricted eating is safe for adults with mild cognitive impairment?

Previous studies have shown that time-restricted eating (TRE) is safe and well-tolerated by older adults. Participants fasted for 16 hours and ate during an 8-hour window, with most adapting easily to this routine. Research suggests that TRE might improve brain function and reduce inflammation linked to Alzheimer's disease. Significant harmful effects have not been reported, making TRE a promising and safe approach for improving health for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using time-restricted eating for Alzheimer's disease because it offers a novel approach by focusing on when people eat rather than what they eat. Unlike traditional treatments that often rely on medications to manage symptoms, this method aims to potentially influence brain health through metabolic changes triggered by fasting. Time-restricted eating might improve cellular repair and brain function, offering a non-pharmaceutical option that could complement existing therapies. Additionally, this approach is relatively easy for participants to adopt and maintain, making it a practical lifestyle change that could support overall well-being.

What evidence suggests that time-restricted eating might be an effective treatment for Alzheimer's disease?

This trial will evaluate the effects of time-restricted eating, where participants fast for 16 hours and eat during an 8-hour period, on brain function in people with Alzheimer's disease. Research has shown that this eating pattern might improve skills like planning and decision-making. Other studies suggest it might also help the body align better with its natural daily rhythms, possibly easing disease symptoms. This method is generally safe and simple for older adults to try. While more research is needed, these early results are promising for improving brain health. ^{3 4 6 7 8}

Who Is on the Research Team?

Yonas E Geda, MD, MSc

Principal Investigator

Barrow Neurological Institute, Alzheimer's Disease and Cognitive Disorders Division

Are You a Good Fit for This Trial?

This trial is for adults with mild cognitive impairment (MCI) who may have Alzheimer's. Participants will try a special eating schedule, fasting for 16 hours and only eating within an 8-hour window on weekdays for three months. The study aims to see if this can improve thinking skills and health markers in the blood.

Inclusion Criteria

Meet Mayo Clinic Criteria for MCI

Body mass index >18.5 and <40.0 kg/m2

Proficiency in speaking and reading English or having a family member who is proficient in reading and speaking English and is willing to serve as a translator

Exclusion Criteria

Eating disorder

I have diabetes that needs insulin or is not well-controlled.

Contraindication to time-restricted eating

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants follow a 16/8 time-restricted eating regimen characterized by fasting for 16 hours and eating within an 8-hour window on 5 days per week for 3 months

12 weeks

Individual and group sessions for education, coaching, and support

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Time Restricted Eating

Trial Overview The TREAD study tests a dietary intervention called time-restricted eating, where participants fast daily for 16 hours and eat during an 8-hour period. This non-randomized trial involves all volunteers following the regimen, with assessments before and after the three-month period to measure its impact.

How Is the Trial Designed?

Group I: Interventional Experimental Treatment 1 Intervention

Participants will be instructed to follow a 16/8 regimen characterized by 16 hours of fasting and an 8-hour eating window daily, on approximately 5 days/week, for 3 months. Previous research has shown that 16 hours of fasting is feasible, safe and well-tolerated among older adults, and that most persons report easy adjustment (Anton, Lee et al. 2019, Lee, Sypniewski et al. 2020). The intervention will be implemented through individual and group sessions with participants and will involve extensive education, coaching, guidance, and support throughout the 3-month intervention. Educational materials on lifestyle factors including physical activity will be provided to each participant. We will be also be collecting data on physical activity and sedentary behavior. These data will be co-variates when we conduct the statistical analysis.

Who Is Running the Clinical Trial?

St. Joseph's Hospital and Medical Center, Phoenix

Lead Sponsor

Trials

69

Recruited

17,400+

Arizona State University

Collaborator

Trials

311

Recruited

109,000+

Karlsruhe Institute of Technology

Collaborator

Trials

4

Recruited

510+

Mayo Clinic

Collaborator

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

Time-restricted feeding (TRF) without caloric restriction significantly improved various aspects of Alzheimer's disease in two transgenic mouse models, including reducing amyloid deposition and enhancing memory.

TRF also normalized daily gene transcription patterns related to Alzheimer's and neuroinflammation, suggesting it could be a promising, accessible intervention to slow down or halt the progression of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Circadian modulation by time-restricted feeding rescues brain pathology and improves memory in mouse models of Alzheimer's disease. Whittaker, DS., Akhmetova, L., Carlin, D., et al.[2023]

Pharmacological treatments for Alzheimer's disease have been largely ineffective, but multimodal strategies like diet, exercise, and cognitive training show promise in prevention and treatment.

Diets such as the Mediterranean, DASH, and MIND diets, which are rich in neuroprotective compounds, may help protect the brain and prevent Alzheimer's disease, while intermittent fasting and calorie restriction have been linked to improvements in brain health and cognitive function in animal models.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrients in the Prevention of Alzheimer's Disease. Cremonini, AL., Caffa, I., Cea, M., et al.[2020]

Intermittent fasting (IF) methods, such as alternate day fasting and time-restricted feeding, were studied in animal models of Alzheimer's disease, showing mixed results on β-amyloid levels, with two studies indicating a reduction in these harmful proteins.

Due to the conflicting findings and variations in study designs, more longitudinal research is needed to determine the effectiveness of intermittent fasting as a preventative strategy for Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Studying the Relationship of Intermittent Fasting and β-Amyloid in Animal Model of Alzheimer's Disease: A Scoping Review. Nasaruddin, ML., Syed Abd Halim, SA., Kamaruzzaman, MA.[2021]

Intermittent fasting (IF) has shown potential benefits for brain health and cognitive function, particularly in animal models, but there is currently no clear evidence of short-term cognitive improvements in healthy humans.

Clinical studies suggest that IF may help manage symptoms and progression of brain disorders such as epilepsy, Alzheimer's disease, and multiple sclerosis, indicating its potential as a therapeutic intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Intermittent Fasting on Brain and Cognitive Function. Gudden, J., Arias Vasquez, A., Bloemendaal, M.[2021]

In a study of 411 non-demented older adults, those who had low meal frequency (less than three meals a day) showed significantly lower levels of beta-amyloid deposition in the brain, which is associated with Alzheimer's disease pathology.

The research also found that lower meal frequency was linked to higher levels of serum ghrelin, suggesting that this hunger-related hormone may mediate the relationship between meal frequency and reduced amyloid deposition, potentially lowering the risk of Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of low meal frequency with decreased in&#160;vivo Alzheimer's pathology. Kim, JW., Byun, MS., Yi, D., et al.[2022]

A combination of glucagon-like peptide-1 (GLP-1) treatment and time-restricted feeding (TRF) significantly improved circadian rhythms in transgenic Alzheimer's disease (AD) mice, affecting their activity-rest cycles, feeding patterns, and hormone secretion.

This dual treatment not only enhanced metabolic homeostasis and cognitive functions in the mice but also positively influenced the expression of key clock genes and reduced neurodegeneration and neuroinflammation, suggesting a potential therapeutic strategy for managing AD symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resetting the circadian clock of Alzheimer's mice via GLP-1 injection combined with time-restricted feeding. Dong, Y., Cheng, L., Zhao, Y.[2022]

Time-restricted feeding (TRF) has shown protective effects against neurodegeneration in two different mouse models of Alzheimer's disease, suggesting it may help synchronize circadian rhythms disrupted in this condition.

The study highlights potential mechanisms by which TRF could benefit brain health, indicating a promising area for further research in Alzheimer's disease management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-restricted feeding and Alzheimer's disease: you are when you eat. King, MW., Chen, Y., Musiek, ES.[2023]

Time-restricted feeding can positively influence circadian rhythms, which are often disrupted in Alzheimer's disease, potentially slowing the disease's progression.

The study used mouse models of Alzheimer's to demonstrate that adjusting feeding times can alter the trajectory of the disease, suggesting a new avenue for therapeutic intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Restricting mealtime ameliorates neurodegeneration. Tian, X., Sinclair, DA.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7827225/

Association between Time Restricted Feeding and ... The results of this study reveal that time restricted eating may be positively associated with cognitive status, and thus exert plausible effects on brain ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1550413123002735

Circadian modulation by time-restricted feeding rescues ... We show that time-restricted feeding (TRF) without caloric restriction improved key disease components including behavioral timing, disease pathology, ...

3. alzdiscovery.org alzdiscovery.org/uploads/cognitive_vitality_media/Time_restricted_eating.pdf

Time restricted eating Time-restricted feeding has been shown to slow tumor growth and restore circadian rhythms in preclinical models [61], however, not all tumor types appear to be ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/imt2.70006

Time‐restricted feeding mitigates Alzheimer's disease ... Time-restricted feeding (TRF) improved cognitive function in Alzheimer's disease (AD) patients, with notable enhancement in executive function.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06429124

Time Restricted Eating in Alzheimer's Disease Previous research has shown that 16 hours of fasting is feasible, safe and well-tolerated among older adults, and that most persons report easy adjustment ( ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5388543/

Fasting, circadian rhythms, and time restricted feeding in ... Frequent eating in this model causes chronic disruption of the circadian clock and dampens molecular circadian rhythms (Hatori et al., 2012).

7. sciencedirect.com sciencedirect.com/science/article/pii/S0531556522003424

The effects of time-restricted eating on sleep, cognitive ... Preliminary evidence suggests that TRE may produce neuroprotective effects on cognition and reduce neuroinflammatory markers related to AD in humans.

8. academic.oup.com academic.oup.com/edrv/article/43/2/405/6371193

Time-restricted Eating for the Prevention and Management of ... Pilot human intervention studies have reported promising results in reducing the risk for obesity, diabetes, and cardiovascular diseases. Epidemiological ...