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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

Obesity and related metabolic comorbidities have been associated with more than a 4-fold increased risk of incident cognitive impairment, including Alzheimer's disease and related dementias (ADRD). Dysfunctional metabolic flexibility is increasingly recognized as a critical mechanism linking metabolic risk factors to risk of cognitive impairment, although few studies portable behavioral strategies to enhance metabolic function among individuals at risk for ADRD. The present study will examine the feasibility and acceptability of a 12-week time restricted feeding intervention among individuals with mild cognitive impairment (MCI). Changes in cognitive and metabolic function will also be examined.

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 data supports the idea that Time Restricted Eating for Cognitive Impairment is an effective treatment?

The available research shows that Time Restricted Eating (TRE) can improve memory and reduce brain issues in mouse models of Alzheimer's disease. It helps clear harmful substances from the brain, improves sleep, and aligns daily gene activity with natural body rhythms. However, a study on older Chinese adults found that TRE might be linked to higher rates of cognitive problems. In a small study with overweight older adults, TRE led to weight loss and better quality of life, but no significant changes in cognitive function were observed. Overall, while TRE shows promise in animal studies, its effects on humans, especially for cognitive impairment, are less clear and need more research. ^{1 2 3 4 5}

What safety data exists for time-restricted eating in treating cognitive impairment?

The safety data for time-restricted eating (TRE) in treating cognitive impairment is mixed. In mouse models of Alzheimer's disease, TRE showed potential benefits, such as reducing amyloid deposition and improving memory. However, a study on older Chinese adults found an association between TRE and higher rates of cognitive impairment. Overall, while TRE has shown metabolic benefits in various studies, its effects on cognitive function in humans are not yet conclusive, and further research is needed to fully understand its safety and efficacy. ^{1 2 4 6 7}

Is Time Restricted Eating a promising treatment for cognitive impairment?

Yes, Time Restricted Eating shows promise as a treatment for cognitive impairment. Studies in mice with Alzheimer's disease have shown that it can improve memory, reduce harmful brain deposits, and help with sleep. This suggests it could be a helpful approach for brain health. ^{1 2 3 4 8}

Research Team

Patrick J Smith, PhD, MPH

Principal Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

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.

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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 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]

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 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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Time restricted feeding is associated with poor performance in specific cognitive domains of Suburb-Dwelling older Chinese. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Circadian modulation by time-restricted feeding rescues brain pathology and improves memory in mouse models of Alzheimer's disease. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Time-restricted feeding and Alzheimer's disease: you are when you eat. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Complex physiology and clinical implications of time-restricted eating. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

The Effects of Time Restricted Feeding on Overweight, Older Adults: A Pilot Study. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Will Delaying Breakfast Mitigate the Metabolic Health Benefits of Time-Restricted Eating? [2021]

7. China pubmed.ncbi.nlm.nih.gov

[Research progress on the application of time-restricted eating in adult obesity and related metabolic diseases]. [2022]

8. United States 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. [2015]