Time Restricted Eating for Obesity

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Insulin, Sulfonylureas, Weight loss drugs

Disqualifiers: Cancer, Breastfeeding, Pregnant, Eating disorders, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

100 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this pilot study is to understand the difference between early and late time-restricted eating on weight and body mass index (BMI), and evaluate the barriers encountered and the effect on quality of life.

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 insulin, sulfonylurea drugs, or weight loss medications.

What data supports the effectiveness of the treatment Early time-restricted eating and Late time-restricted eating for obesity?

Research shows that time-restricted eating (TRE) can help reduce body weight, waist circumference, and blood pressure in adults with overweight and obesity. TRE involves eating within a specific time window each day, which can improve metabolic health and support weight loss. ^{1 2 3 4 5}

Is time-restricted eating safe for humans?

Research shows that time-restricted eating, where food is consumed within a specific time window each day, is generally safe for adults with obesity. Studies found no significant adverse effects on health markers like blood count or eating patterns, suggesting it can be a safe approach for weight management. ^{1 2 3 6 7}

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

Time-restricted eating (TRE) is unique because it focuses on limiting the hours during which you eat each day, rather than changing what you eat. This approach aligns eating patterns with the body's natural circadian rhythms, potentially enhancing metabolic benefits and weight loss without altering calorie intake or diet composition. ^{2 4 7 8 9}

Research Team

Bradley Bohn, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for obese adults with a BMI of 25 or higher who are willing to limit their eating to an 8-hour window. It's not suitable for those with cancer, pregnant or breastfeeding women, individuals who regularly skip meals, those on certain diabetes or weight loss medications, and people with a history of eating disorders.

Inclusion Criteria

- BMI ≥ to 25.

BMI ≥ to 25

Exclusion Criteria

Have a current cancer diagnosis

Currently breastfeeding

Regularly skip meals

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants follow a time-restricted eating schedule for 12 weeks, either early or late window

12 weeks

Baseline and end of study visits

Follow-up

Participants are monitored for changes in weight, cholesterol, glucose, and other health markers

4 weeks

Treatment Details

Interventions

• Early time-restricted eating
• Late time-restricted eating

Trial Overview The study is examining the effects of early versus late time-restricted eating on weight and BMI in obese adults. Participants will be asked to eat only during an 8-hour period each day to see how this impacts their health and quality of life.

Participant Groups

Group I: Late time-restricted eating Experimental Treatment 1 Intervention

Subjects window for eating would be between 12:00 PM (noon) and 8:00 PM

Group II: Early time-restricted eating Experimental Treatment 1 Intervention

Subjects window for eating would be between 08:00 AM - 4:00 PM

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Findings from Research

A survey of 213 families attending pediatric weight management programs found that 66% of parents were interested in trying time-limited eating (TLE) for 12 hours a day, indicating a strong acceptability of this dietary approach among families.

Interest in TLE decreased significantly when the eating window was limited to 10 hours (39%) or 8 hours (26%), suggesting that flexibility in the eating schedule may enhance adherence to dietary interventions for childhood obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability of Time-Limited Eating in Pediatric Weight Management. Tucker, JM., Siegel, R., Murray, PJ., 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 12-week study involving 23 obese adults, time-restricted feeding (TRF) with an 8-hour eating window was found to be safe, as there were no significant changes in self-reported adverse events or disordered eating patterns.

The study suggests that TRF can effectively support weight loss in obese individuals without negatively impacting their health or body image perception.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of 8-h time restricted feeding in adults with obesity. Gabel, K., Hoddy, KK., Varady, KA.[2019]

In a study involving 99 participants over three months, time-restricted eating (TRE) did not show significant differences in obesity-related outcomes based on the timing of food intake, whether early, medium, or late.

Participants who started eating earlier had a longer eating duration but the late eaters had a longer fasting period, suggesting that the timing of food intake may not be as crucial as previously thought, and further research is needed to clarify these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early or Delayed Onset of Food Intake in Time-Restricted Eating: Associations with Markers of Obesity in a Secondary Analysis of Two Pilot Studies. Kesztyüs, D., Cermak, P., Kesztyüs, T., et al.[2023]

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 involving overweight and obese young adults, both early time-restricted eating (eTRE) and late time-restricted eating (lTRE) resulted in similar weight loss after 8 weeks compared to a control group.

eTRE was more effective than lTRE in improving several metabolic health markers, including reducing systolic blood pressure, glucose levels, fasting insulin, insulin resistance, and thyroid axis activity, while lTRE only reduced leptin levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial for time-restricted eating in overweight and obese young adults. Zhang, LM., Liu, Z., Wang, JQ., et al.[2022]

In an 8-week pilot study involving 78 participants with obesity, those following a 14-hour time-restricted eating (TRE) schedule lost an average of 8.5% of their body weight, which was statistically significant compared to a 12-hour TRE group that lost 7.1%.

The 14:10 TRE group also experienced a significant reduction in fasting blood glucose levels by 7.6 mg/dl, indicating potential metabolic benefits, especially for those with elevated blood glucose at baseline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of time restricted eating on body weight and fasting glucose in participants with obesity: results of a randomized, controlled, virtual clinical trial. Peeke, PM., Greenway, FL., Billes, SK., et al.[2021]

This study is the first to evaluate the effects of time-restricted eating (TRE) on weight loss in a controlled manner, comparing it to a usual eating pattern (UEP) while ensuring both groups consumed the same number of calories and identical diets.

Participants aged 21-69 with prediabetes and obesity were monitored closely, allowing for a rigorous assessment of how meal timing impacts weight change without altering caloric intake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and Implementation of a Time-Restricted Eating Intervention in a Randomized, Controlled Eating Study. White, K., Wu, B., Pilla, SJ., et al.[2023]

Time-restricted feeding (TRF) significantly reduced body weight and body mass index (BMI) in female college students with hidden obesity over an 8-week period, but it also led to increased blood lipid levels and decreased lean tissue mass.

Combining TRF with exercise did not provide additional benefits compared to TRF or exercise alone, indicating that TRF may not be the most effective strategy for fat reduction in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of time-restricted feeding and walking exercise on the physical health of female college students with hidden obesity: a randomized trial. Liu, H., Chen, S., Ji, H., et al.[2023]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Acceptability of Time-Limited Eating in Pediatric Weight Management. [2023]

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. Canada pubmed.ncbi.nlm.nih.gov

Safety of 8-h time restricted feeding in adults with obesity. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Early or Delayed Onset of Food Intake in Time-Restricted Eating: Associations with Markers of Obesity in a Secondary Analysis of Two Pilot Studies. [2023]

5. China pubmed.ncbi.nlm.nih.gov

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

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

Randomized controlled trial for time-restricted eating in overweight and obese young adults. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Effect of time restricted eating on body weight and fasting glucose in participants with obesity: results of a randomized, controlled, virtual clinical trial. [2021]

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

Design and Implementation of a Time-Restricted Eating Intervention in a Randomized, Controlled Eating Study. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of time-restricted feeding and walking exercise on the physical health of female college students with hidden obesity: a randomized trial. [2023]