Time-Restricted Eating for Cognitive Health in Obesity

Overseen By Stephen Anton, PhD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Must not be taking: Antidepressants, Antipsychotics, Antibiotics, others

Disqualifiers: Cardiovascular disease, Diabetes, Cancer, others

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

Compensation: Varies

Number of Visits: 3

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a time-restricted eating method, where participants fast for 16 hours daily, can boost brain health and improve sleep, mood, and quality of life in older adults with memory challenges. Participants will either follow this fasting schedule or join a group focusing on general healthy aging tips (Successful Aging Comparison Group, also known as LEARN) for 24 weeks. The trial seeks individuals over 65 who are overweight, have noticed memory or planning issues in the last five years, and feel these issues are worse than those of their peers. As an unphased trial, this study provides a unique opportunity to explore innovative lifestyle changes that could enhance well-being.

Will I have to stop taking my current medications?

Yes, you may need to stop taking certain medications. The trial excludes participants who are currently using anabolic medications, certain antidepressants, antipsychotic agents, and other specific drugs. It's best to discuss your current medications with the trial team to see if they are allowed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that time-restricted eating (TRE) is generally safe for most people. Studies have found that adults with obesity who practice TRE often reduce their daily calorie intake by 200 to 550 calories. This suggests that TRE is usually well-tolerated without major negative effects.

Additionally, some research indicates that people practicing TRE, especially those over 70, might experience fewer mental health issues. However, findings are mixed. For instance, one study found a higher risk of heart-related death with an 8-hour eating window. This underscores the importance of monitoring health and consulting healthcare providers when considering TRE.

In summary, while TRE may offer benefits like reduced calorie intake and possible mental health improvements, caution and medical advice are important, especially for those with existing health concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about time-restricted eating (TRE) for cognitive health in obesity because it offers a novel approach by focusing on when you eat rather than what you eat. Unlike traditional methods that may rely on calorie counting or specific diet plans, TRE encourages participants to limit their eating to an 8-hour window each day, potentially enhancing metabolic health and cognitive function. This method is particularly intriguing as it may help improve brain health without the need for medication, offering a lifestyle-based alternative that could be easier for some people to adopt. Moreover, TRE might help control hunger and reduce the overall calorie intake naturally, making it a practical option for many individuals with obesity.

What evidence suggests that this trial's treatments could be effective for cognitive health in obesity?

This trial will compare the effects of Time Restricted Eating (TRE) with a Successful Aging Comparison Group (LEARN) on cognitive health in individuals with obesity. Research has shown that TRE can help people with obesity lose a small amount of weight, with studies finding a weight loss of about 3% to 5% over 2 to 12 months. TRE also lowers fasting insulin levels, benefiting metabolism. However, it is not more effective for weight loss than other calorie-reduction methods. The effects of TRE on brain function remain under study, but its metabolic benefits could improve overall health. ^{6 7 8 9 10}

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 overweight older adults (age > 65) with a BMI over 25 and some self-reported cognitive difficulties. They should not have severe diseases like heart disease, diabetes, or neurologic conditions, nor be on certain medications that interfere with fasting.

Inclusion Criteria

Body Mass Index (BMI > 25 kg/m2)

Responds yes to questions 1 (memory worse), 2 (word finding difficulties) or 3 (planning/organization difficulties) on the Subjective Cognitive Decline Questionnaire

Reports onset of cognitive difficulties in past five years

Exclusion Criteria

Terminal illness with life expectancy less than 12 months, as determined by a physician

I have a history of lung disease.

I have not had a heart attack, stroke, or unstable angina in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants are assigned to either a Time Restricted Eating (TRE) intervention or a Successful Aging (SA) comparison group for a 24-week period

24 weeks

Regular visits (in-person and virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Successful Aging Comparison Group (LEARN)
• Time Restricted Eating intervention

Trial Overview The study tests if a time-restricted eating plan improves brain function and aging. Participants will either fast for about 16 hours daily or follow successful aging advice for six months to see which helps more.

How Is the Trial Designed?

Group I: Time Restricted Eating intervention Experimental Treatment 1 Intervention

In the time restricted eating condition, participants will be instructed to fast for a target of 16 hours per day for a 24 week period.

Group II: Successful Aging Comparison Group (LEARN) Active Control 1 Intervention

In the LEARN group, participants will be educated on health related topics similar to that of the TRE intervention for 24 weeks.

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Florida Department of Health, Ed and Ethel Moore Alzheimer's Disease Research Program

Collaborator

Trials

1

Recruited

50+

Published Research Related to This Trial

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 50 adults with overweight and obesity, participants successfully reduced their eating window from an average of 16 hours to about 12 hours over a 90-day time-restricted eating (TRE) intervention, leading to significant weight loss and reductions in waist circumference and blood pressure.

The TRE approach, which required no dietary counseling and was monitored through a smartphone app, showed a feasible and effective way to improve eating patterns and health outcomes in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Smartphone Intervention to Promote Time Restricted Eating Reduces Body Weight and Blood Pressure in Adults with Overweight and Obesity: A Pilot Study. Prasad, M., Fine, K., Gee, A., et al.[2021]

In a study of 24 university students, those following early time-restricted eating (eTRE) showed a significant 27% decrease in cognitive response time on the TMT-B test after 4 weeks, compared to only a 6% decrease in the control group, suggesting eTRE may enhance cognitive acuity.

The study found a strong inverse correlation between TMT-B response time and plasma levels of β-hydroxybutyrate (BHB), indicating that higher ketone levels may be associated with improved cognitive performance, although further research is needed to confirm these preliminary findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early time-restricted eating may favorably impact cognitive acuity in university students: a randomized pilot study. Mayra, ST., Kravat, N., Chondropoulos, K., et al.[2022]

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]

Intermittent fasting (IF) led to greater weight and body fat loss compared to calorie restriction (CR) in a study of 46 healthy women with overweight or obesity, suggesting that IF may be a more effective short-term weight loss strategy.

Despite the differences in weight loss, both IF and CR did not significantly affect perceived eating behaviors, mood, sleep quality, or cognitive performance, indicating that IF is a safe alternative to CR without negative impacts on psychological or cognitive outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eight weeks of intermittent fasting versus calorie restriction does not alter eating behaviors, mood, sleep quality, quality of life and cognitive performance in women with overweight. Teong, XT., Hutchison, AT., Liu, B., et al.[2021]

Time-restricted eating (TRE) allows individuals to eat within a specific time window of 4-12 hours, which may lead to weight loss and improved metabolic health without explicitly reducing calorie intake, as suggested by preliminary studies.

TRE may offer advantages over traditional caloric restriction by helping individuals maintain their usual dietary preferences and cope with social pressures to overeat, although it may also present challenges for those with poor diet quality or competing demands on their time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspective: Time-Restricted Eating Compared with Caloric Restriction: Potential Facilitators and Barriers of Long-Term Weight Loss Maintenance. O'Connor, SG., Boyd, P., Bailey, CP., et al.[2023]

Time-restricted eating (TRE) has gained attention for its potential benefits on metabolic and cardiovascular diseases related to obesity, with a significant increase in research publications since 2016, totaling 414 studies.

Key research hotspots include the relationship between TRE and circadian rhythms, obesity, and metabolic diseases, indicating that TRE could be a promising approach for managing conditions like Type 2 diabetes and cardiovascular issues, though more high-quality studies are needed to fully understand its mechanisms and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bibliometric and visual analysis of time-restricted eating. Wang, S., Lin, X., Guan, Y., et al.[2022]

In a study of 1,572 southern Italian adults, time-restricted feeding (TRF) was associated with lower signs of mental health distress in individuals over 70 years old, suggesting a potential benefit of this dietary pattern for older adults.

However, the association was influenced by whether participants had breakfast, indicating that meal timing and dietary habits may interact in complex ways affecting mental health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-restricted feeding is associated with mental health in elderly Italian adults. Currenti, W., Godos, J., Castellano, S., et al.[2021]

Citations

1. 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.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1550413123004540

Time-restricted eating: Watching the clock to treat obesity In participants with obesity, time-restricted eating results in 3%–5% weight loss over 2–12 months, versus controls. Reductions in body weight ...

3. 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).

4. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2771095

Effects of Time-Restricted Eating on Weight Loss and Other ... Time-restricted eating, in the absence of other interventions, is not more effective in weight loss than eating throughout the day.

5. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2025.1664412/full

Effects of time-restricted eating on body composition and ... Conclusion: TRE is effective in reducing body weight and lowering fasting insulin in overweight and obese women, without negatively affecting lean body mass.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11221496/

Time-restricted eating: Watching the clock to treat obesity Indeed, evidence shows that when adults with obesity limit their eating window to 4–10 h per day, they naturally reduce energy intake by 200–550 kcal/day.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2211335524001724

Effect of time-restricted eating and intermittent fasting on ... Cross-sectional studies revealed that individuals practicing TRE were less likely to exhibit signs of mental health distress, particularly those aged over 70 ...

8. newsroom.heart.org newsroom.heart.org/news/8-hour-time-restricted-eating-linked-to-a-91-higher-risk-of-cardiovascular-death

8-hour time-restricted eating linked to a 91% higher risk of ... 8-hour time-restricted eating linked to a 91% higher risk of cardiovascular death. American Heart Association Epidemiology and Prevention| ...

9. nutritionj.biomedcentral.com nutritionj.biomedcentral.com/articles/10.1186/s12937-025-01091-y

Time-restricted eating (TRE) for obesity in general practice ... The primary outcome is change in body weight under a 6-month period of TRE. Secondary outcomes are related to the patient (e.g. quality of life) ...

10. nature.com nature.com/articles/s41430-023-01311-w

Time-restricted eating with calorie restriction on weight loss ... The present meta-analysis aimed to evaluate the efficacy of TRE with CR on weight loss and cardiometabolic risk.