Time Restricted Eating for Aging

Overseen By Stephen Anton

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Must not be taking: Diabetes medications

Disqualifiers: Diabetes, Cancer, Heart attack, others

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

Compensation: Varies

Number of Visits: 2

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how time-restricted eating (ending meals by 7 PM and fasting for 16 hours daily) affects metabolism and body rhythms in older adults. The goal is to determine if this eating pattern can enhance cell and energy production health. Participants adjust their daily eating schedule and maintain a diary of their eating and sleeping habits. Suitable candidates are those aged 65 or older who struggle to walk a quarter mile or climb stairs, are not very active, and have a body mass index (a measure of body fat based on height and weight) between 25 and 40. As an unphased trial, this study provides a unique chance to contribute to scientific understanding and potentially improve personal health.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking medications that require you to eat more frequently than every 16 hours.

What prior data suggests that time-restricted eating is safe for older adults?

Research has shown that time-restricted eating (TRE) is generally safe for most people. One study found that a four-week TRE program was feasible and acceptable for older adults who were overweight and not very active, indicating that many can follow the routine without major problems.

Another study suggested that TRE might improve heart health in older adults without requiring them to eat less. These studies reported no significant serious side effects.

Although the current trial is in an early stage, which often means limited safety information, previous findings suggest that TRE is usually well-tolerated. Participants can typically maintain their daily activities without issues, simply by adjusting when they eat. Always consult a healthcare provider to ensure it suits individual health needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Time Restricted Eating (TRE) intervention for aging because it offers a simple, non-pharmaceutical approach to potentially improve health outcomes. Unlike traditional treatments that may involve medications or supplements, this method focuses on adjusting eating patterns to align with the body's natural circadian rhythms. By encouraging participants to fast for 16 hours daily, the TRE approach may enhance metabolic health and support weight management with minimal lifestyle disruption. Additionally, this method allows individuals to consume calorie-free beverages during fasting, which can make adherence easier and more sustainable compared to other dietary interventions.

What evidence suggests that time-restricted eating might be an effective treatment for aging?

Research has shown that time-restricted eating (TRE), which participants in this trial will follow, can offer several health benefits. Studies suggest that TRE might enhance brain function and mental well-being. It could also aid weight management and overall health by improving metabolism. However, TRE alone has not proven more effective for weight loss than simply reducing calories throughout the day. Additionally, some studies have linked intermittent fasting, including TRE, to longer lifespans. For older adults, TRE might improve energy use and promote healthier cells. ^{1 6 7 8 9}

Who Is on the Research Team?

Stephen Anton

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

This trial is for men and women aged 65 or older who are overweight, have difficulty walking or climbing stairs, do not exercise much (less than 150 minutes of structured exercise per week), and can walk unassisted. They should not be actively trying to lose weight through other programs, must not have diabetes, unstable heart conditions, certain severe diseases like Parkinson's or rheumatoid arthritis, or be on treatments that prevent fasting for 16 hours.

Inclusion Criteria

I walk slower than 1 meter per second.

I am 65 years old or older.

Have a body mass index between 25 - 40 kg/m2 (inclusive)

Exclusion Criteria

Resting heart rate of >120 beats per minute, systolic blood pressure > 180 mmHg and/or diastolic blood pressure of > 100 mmHg

Fasting >12 hours per day

I have been treated for cancer within the last year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Time Restricted Eating Intervention

Participants will gradually increase fasting duration to 16 hours per day over 8 weeks, with dietary logs maintained.

8 weeks

Weekly check-ins (virtual or in-person)

Follow-up

Participants are monitored for changes in metabolic and circadian health markers after the intervention.

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Time Restricted Eating Intervention

Trial Overview The FAR Phase 2 Study is testing how time-restricted eating affects the body's fuel metabolism and internal clock in older adults. The goal is to find easy ways to measure changes in these areas after following a diet that limits when participants can eat during the day.

How Is the Trial Designed?

Group I: Time Restricted Eating intervention Experimental Treatment 1 Intervention

Participants will be asked to stop eating by 7 PM every day and to fast for a target of 16 hours per day for 8 weeks. During the first two weeks of the intervention, participants will gradually ramp up to a full 16-hour fasting period (Week 1 - fast for 12-14 hours per day, Week 2 - fast for 14-16 hours per day, Week 3 - 8 - fast for 16 hours per day). Participants will be allowed to consume calorie-free beverages, tea, black coffee, sugar-free gum, and they will be encouraged to drink plenty of water throughout the entire intervention period. Additionally, they will be asked to keep a Fasting and Sleeping diary logging their eating habits and sleep quality.

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Florida Department of Health

Collaborator

Trials

30

Recruited

13,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

Time-restricted eating (TRE) for 16 hours a day over six weeks led to significant reductions in body weight (-1.92 kg), visceral fat mass (-0.64 l), and waist circumference (-3.11 cm) in a group of 23 early elderly men with overweight, compared to a control group.

The study demonstrated that TRE is feasible and easy to maintain for elderly men, suggesting it could be an effective tool for managing obesity in this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a six-week times restricted eating intervention on the body composition in early elderly men with overweight. Domaszewski, P., Konieczny, M., Pakosz, P., et al.[2022]

In a pilot study involving 10 older adults (average age 77.1 years), time-restricted feeding (TRF) for 16 hours daily was generally well tolerated, with 9 participants completing the protocol and most reporting minimal difficulty adjusting to the fasting schedule.

Adverse events were rare, primarily consisting of mild headaches and dizziness, which were manageable, indicating that TRF can be a safe dietary approach for older adults, although clearer instructions may be needed to enhance understanding and adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determinants of Adherence in Time-Restricted Feeding in Older Adults: Lessons from a Pilot Study. Lee, SA., Sypniewski, C., Bensadon, BA., et al.[2020]

A time-restricted eating (TRE) intervention designed for people with type 2 diabetes and overweight includes a two-phase approach: an initial strict phase followed by a more flexible phase tailored to individual needs.

Support from healthcare professionals, family, and peers is crucial for maintaining motivation and adherence to the TRE regimen, emphasizing a whole-person approach that considers participants' past experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Designing a Co-created Intervention to Promote Motivation and Maintenance of Time-Restricted Eating in Individuals With Overweight and Type 2 Diabetes. Hempler, NF., Bjerre, N., Varming, AR., et al.[2023]

In a 12-week study involving 20 adults with a BMI of 25 kg/m2 or higher, time-restricted eating (TRE) significantly reduced the frequency of eating occasions by 28% compared to only 12% in the non-TRE group, indicating a more structured eating pattern.

TRE participants also reported a notable decrease in both high and low-quality snacks and caffeinated beverage intake, suggesting that this eating pattern not only aids in weight loss but also promotes healthier dietary choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-Restricted Eating Alters Food Intake Patterns, as Prospectively Documented by a Smartphone Application. Malaeb, S., Harindhanavudhi, T., Dietsche, K., et al.[2022]

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]

In a 12-week study involving 14 adults with obesity, time-restricted feeding (8-hour eating window) led to a significant weight loss of about 2 kg, indicating potential efficacy for weight management.

Despite the weight loss, the study found no significant changes in the diversity or composition of the gut microbiome, suggesting that time-restricted feeding may not impact gut health in terms of microbial diversity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of time restricted feeding on the gut microbiome in adults with obesity: A pilot study. Gabel, K., Marcell, J., Cares, K., et al.[2022]

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]

A 12-week time-restricted eating (TRE) intervention improved emotional health and perceived health changes in participants compared to baseline, indicating potential benefits for quality of life.

Participants in the TRE group reported greater improvements in emotional health limitations and perceived health changes compared to those with unrestricted eating, suggesting that TRE may enhance overall well-being without negatively impacting quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-Restricted Eating Improves Quality of Life Measures in Overweight Humans. Crose, A., Alvear, A., Singroy, S., et al.[2021]

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 of 95 adults with metabolic syndrome, time-restricted feeding (TRF) during Ramadan led to significant reductions in arterial stiffness and improved cardiovascular markers, such as pulse wave velocity and central systolic pressure.

The Ramadan fasting group showed notable improvements in arterial health, suggesting that TRF could be a beneficial dietary strategy for enhancing cardiovascular health and potentially extending lifespan.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of time-restricted feeding, arterial age, and arterial stiffness in adults with metabolic syndrome. Alinezhad-Namaghi, M., Eslami, S., Nematy, M., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10820472/

Impact of Intermittent Fasting and/or Caloric Restriction on ... This scoping review examined the cardiometabolic, cancer, and neurocognitive outcome differences between IF and CR interventions among adults.

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10672223/

Time-Restricted Eating and Its Metabolic Benefits - PMC The findings showed that TRE, in the absence of other interventions, was no more effective for weight loss than continuous calorie restriction.

4. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-53702400098-1/fulltext

Intermittent fasting and health outcomes: an umbrella ... Benefits of Intermittent fasting (IF) on health-related outcomes have been found in a range of randomised controlled trials (RCTs).

5. nature.com nature.com/articles/s41586-024-08026-3

Dietary restriction impacts health and lifespan of ... We show that caloric restriction and intermittent fasting both resulted in lifespan extension in proportion to the degree of restriction.

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6682944/

The Effects of Time Restricted Feeding on Overweight, Older ... The primary findings of this pilot study were that a four-week TRF intervention was feasible and acceptable in overweight, sedentary older ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0828282X24000928

Risks and Benefits of Intermittent Fasting for the Aging ... In addition, time-restricted feeding (TRF) without reducing caloric intake was shown to attenuate age-induced decline in cardiac function through the ...

9. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2811116

Effect of Time-Restricted Eating on Weight Loss in Adults ... In a 6-month randomized clinical trial involving 75 adults with T2D, TRE was more effective for weight loss (−3.6%) than CR (−1.8%) compared with controls.