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

52 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Grounded in the principles of geroscience, the proposed Fasting ENHANCE study will test whether a time restricted eating (TRE) regimen can improve cognitive function and other aspects of successful aging in a safe and sustainable manner in at risk overweight older adults. Specifically, this study will evaluate whether TRE can improve cognitive and physical function, as well as self-reported sleep, mood, and quality of life, in overweight, older adults (age \> 65 years) who are at high risk of cognitive decline due to self-reported cognitive difficulties. Eligible participants will be assigned to either a TRE intervention, in which they will be instructed to fast for a target of 16 hours per day, or a successful aging (SA) comparison group for a 24-week period.

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 time-restricted eating safe for humans?

Time-restricted eating (TRE), a form of intermittent fasting, has been studied in humans and generally appears safe, with no adverse effects on mood, sleep quality, or cognitive performance in short-term studies. However, more extensive and long-term research is needed to confirm its safety across diverse populations. ^{1 2 3 4 5}

How does time-restricted eating differ from other treatments for obesity?

Time-restricted eating (TRE) is unique because it focuses on limiting the time window for eating each day, rather than restricting calories or specific foods. This approach aligns eating patterns with the body's natural circadian rhythms, potentially improving metabolic health and aiding weight loss without the need for strict dietary changes. ^{1 3 5 6 7}

What data supports the effectiveness of the treatment Time-Restricted Eating for Cognitive Health in Obesity?

Research suggests that time-restricted eating (TRE) can lead to weight loss and improvements in metabolic health, which may indirectly support cognitive health. Additionally, a study found that early time-restricted eating (eTRE) improved cognitive acuity in university students, indicating potential cognitive benefits. ^{2 4 5 6 8}

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)

Reports onset of cognitive difficulties in past five years

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

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

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]

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]

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]

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 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]

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]

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 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]

Citations

1. United States 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. [2021]

2. Switzerland 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. [2021]

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

Perspective: Time-Restricted Eating Compared with Caloric Restriction: Potential Facilitators and Barriers of Long-Term Weight Loss Maintenance. [2023]

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

Early time-restricted eating may favorably impact cognitive acuity in university students: a randomized pilot study. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Time-restricted feeding is associated with mental health in elderly Italian adults. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Bibliometric and visual analysis of time-restricted eating. [2022]

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

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

8. Switzerland pubmed.ncbi.nlm.nih.gov

Time-Restricted Eating Alters Food Intake Patterns, as Prospectively Documented by a Smartphone Application. [2022]