Time Restricted Eating for Cognitive Impairment

(TEMPO Trial)

Overseen By Caroline Nelson, MPH, RD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Must not be taking: Insulin

Disqualifiers: Dementia, Heart failure, Diabetes, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether time-restricted eating can improve brain function in people with mild memory problems. The focus is on individuals who are obese and have mild cognitive impairment, a condition affecting memory but not as severe as dementia. Participants will adjust their eating to a 16-hour fasting period a few days each week, working with a psychologist to implement the changes. Ideal candidates are aged 65-80, are obese, have mild memory issues, and lead a sedentary lifestyle. As an unphased trial, participants contribute to groundbreaking research that may enhance cognitive health strategies.

Do I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have diabetes requiring insulin, you would be excluded from participating.

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

Research has shown that time-restricted eating (TRE) might safely enhance both brain and body health. Studies have found that TRE can improve brain function, potentially aiding learning and memory. Additional research suggests that TRE can reduce brain inflammation, which is associated with diseases like Alzheimer's.

No clear reports of serious side effects from TRE exist, indicating it is likely well-tolerated by many. However, as with any lifestyle change, individuals should monitor their body's reactions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Time restricted eating is unique because it offers a non-drug approach to managing cognitive impairment, potentially avoiding the side effects of medications like cholinesterase inhibitors and NMDA receptor antagonists. This method involves modifying eating habits to include periods of fasting, which might improve brain health by enhancing metabolic functions and reducing inflammation. Researchers are excited because this approach could offer a simpler, more natural way to support cognitive function, with the added benefit of being easier to incorporate into daily life compared to traditional medication regimens.

What evidence suggests that time restricted eating might be an effective treatment for cognitive impairment?

Research suggests that time-restricted eating (TRE), which involves eating only during specific hours, might improve brain function. Some studies have linked TRE to better brain health and sharper thinking. In this trial, participants will engage in a 12-week time-restricted fasting intervention to explore its effects on cognitive impairment. For those at risk of memory problems, such as Alzheimer's disease, TRE might help by improving energy use in the body. However, not all research agrees; some studies suggest it might lead to more memory issues. Overall, researchers are studying TRE for its potential to support brain health by aligning eating habits with the body's natural clock. ^{2 6 7 8 9}

Who Is on the Research Team?

Patrick J Smith, PhD, MPH

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

This trial is for men and women aged 65-80 with mild cognitive impairment (MoCA score 19-25) who are sedentary, obese (BMI 30-40), and willing to participate in a time-restricted eating intervention. Excluded are those with heart failure, severe kidney disease, major psychiatric disorders, insulin-dependent diabetes, heavy alcohol use (>14 drinks/week), or any condition that limits exercise.

Inclusion Criteria

Willing to participate in all aspects of the proposed intervention

My BMI is between 30 and 40.

I am between 65 and 80 years old.

Exclusion Criteria

I have severe irregular heartbeats.

I have a serious health condition that could shorten my life.

I have heart failure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 12-week time restricted fasting intervention, working with a clinical psychologist to modify eating behaviors to adhere to a 16-hour fast, 2-3 days per week.

12 weeks

Follow-up

Participants are monitored for changes in cognitive and metabolic function, including assessments of memory, executive function, metabolic flexibility, and inflammation.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Time Restricted Eating

Trial Overview The study tests the feasibility of a 12-week time restricted eating plan among older adults with mild cognitive impairment. It aims to see if this dietary approach can improve both metabolic function and cognition as an easy-to-implement strategy potentially reducing the risk of Alzheimer's disease.

How Is the Trial Designed?

Group I: Time restricted eating Experimental Treatment 1 Intervention

Participants will engage in a 12-week time restricted fasting intervention. Each week, participants will work with a clinical psychologist to modify the timing of their eating behaviors to adhere to a 16-hour fast, 2-3 days per week.

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

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]

Time-restricted eating (TRE), which limits food intake to 6 to 10 hours during the active part of the day, has been shown to improve metabolic health and glucose tolerance in various models, including humans.

Most research on TRE has focused on starting the eating window in the morning, but this paper highlights potential challenges and metabolic effects of delaying the eating window, suggesting that timing may be crucial for maximizing benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Will Delaying Breakfast Mitigate the Metabolic Health Benefits of Time-Restricted Eating? Heilbronn, LK., Regmi, P.[2021]

Time-restricted feeding (TRF) for 16 hours a day over four weeks led to a significant average weight loss of 2.6 kg in a pilot study involving 10 overweight, sedentary older adults, indicating its potential as a weight management strategy.

Participants also experienced clinically meaningful improvements in walking speed and quality of life, with high adherence rates (84%) and few reported adverse events, suggesting that TRF is a safe and feasible dietary approach for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Time Restricted Feeding on Overweight, Older Adults: A Pilot Study. Anton, SD., Lee, SA., Donahoo, WT., et al.[2020]

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]

In a study of 1353 older adults in Shanghai, time-restricted feeding (TRF) was linked to a higher incidence of cognitive impairment, suggesting that limiting eating to a shorter time window may negatively affect cognitive health.

TRF was found to be significantly associated with lower scores in cognitive functions such as 'Orientation to place' and 'Attention/calculation', indicating that restricting meal times could impair specific areas of cognitive performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time restricted feeding is associated with poor performance in specific cognitive domains of Suburb-Dwelling older Chinese. Li, J., Li, R., Lian, X., et al.[2023]

Time-restricted eating (TRE) has shown promising therapeutic effects in rodent studies, particularly in relation to body weight and metabolic health, but results in humans are inconsistent due to varying study designs and populations.

This review highlights the need for more standardized research on TRE in humans to better understand its effects and interactions with circadian biology, as well as to identify gaps in current knowledge for future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complex physiology and clinical implications of time-restricted eating. Petersen, MC., Gallop, MR., Flores Ramos, S., et al.[2023]

In a study using triple-transgenic mice that model Alzheimer's disease, both 40% calorie restriction (CR) and intermittent fasting (IF) diets started at 3 months of age showed protective effects against cognitive decline by 17 months, with CR mice exhibiting improved exploratory behavior and better performance in cognitive tasks compared to those on a control diet.

Calorie restriction was associated with lower levels of harmful amyloid beta and phospho-tau proteins in the hippocampus, suggesting a potential mechanism for its protective effects, while intermittent fasting did not show the same reduction in these proteins, indicating different pathways of action between the two dietary interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent fasting and caloric restriction ameliorate age-related behavioral deficits in the triple-transgenic mouse model of Alzheimer's disease. Halagappa, VK., Guo, Z., Pearson, M., et al.[2015]

Time-restricted eating (TRE) is a promising dietary strategy that can help improve metabolic health and restore circadian rhythms, potentially aiding in the prevention and treatment of obesity and its complications.

Current evidence from previous TRE trials suggests a need for more extensive clinical research, including large-scale controlled trials, to fully understand the efficacy and mechanisms of TRE in humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Research progress on the application of time-restricted eating in adult obesity and related metabolic diseases]. He, JH., Sun, CY., Liang, C.[2022]

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/S2211335524001724

Effect of time-restricted eating and intermittent fasting on ... The findings suggest that TRE and IFA may have a positive impact on cognitive function and mental health in this population.

3. nature.com nature.com/articles/s41598-022-23931-1

Time restricted feeding is associated with poor ... Our study found that TRF may be associated with a higher incidence rate of cognitive impairment. TRF only limited the eating time window and did ...

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

Fasting, circadian rhythms, and time restricted feeding in ... Time-restricted feeding is a daily eating pattern in which all nutrient intake occurs within a few hours (usually ≤12h) everyday, with no overt attempt to alter ...

5. cell.com cell.com/cell-metabolism/fulltext/S1550-4131(23)00273-5

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, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11107340/

Effect of time-restricted eating and intermittent fasting on ... The findings suggest that TRE and IFA may have a positive impact on cognitive function and mental health in this population.

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. sciencedirect.com sciencedirect.com/science/article/pii/S127977072500003X

Intermittent fasting and neurocognitive disorders: What the ... Intermittent fasting (IF) has emerged as a potential lifestyle intervention for mitigating cognitive decline and enhancing brain health.

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

Time restricted eating Neuroprotective Benefit: Time-restricted eating may help restore natural rhythms to pathways involved in learning and memory, and mitigate metabolic risk ...