52 Participants Needed

Time-Restricted Eating for Cognitive Health in Obesity

SA
MG
SA
Overseen ByStephen Anton, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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.

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.12345

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.13467

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.23678

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.

Research Team

SA

Stephen Anton

Principal Investigator

University of Florida

Eligibility Criteria

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
See 4 more

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.
See 21 more

Timeline

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)

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Time Restricted Eating interventionExperimental Treatment1 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 Control1 Intervention
In the LEARN group, participants will be educated on health related topics similar to that of the TRE intervention for 24 weeks.

Find a Clinic Near You

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+

Findings from Research

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.
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.
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.
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]

References

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]
A Smartphone Intervention to Promote Time Restricted Eating Reduces Body Weight and Blood Pressure in Adults with Overweight and Obesity: A Pilot Study. [2021]
Perspective: Time-Restricted Eating Compared with Caloric Restriction: Potential Facilitators and Barriers of Long-Term Weight Loss Maintenance. [2023]
Early time-restricted eating may favorably impact cognitive acuity in university students: a randomized pilot study. [2022]
Time-restricted feeding is associated with mental health in elderly Italian adults. [2021]
Bibliometric and visual analysis of time-restricted eating. [2022]
Complex physiology and clinical implications of time-restricted eating. [2023]
Time-Restricted Eating Alters Food Intake Patterns, as Prospectively Documented by a Smartphone Application. [2022]
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