Time-Restricted Eating for Obesity

Overseen By Stephanie T Chung, M.D.

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Must not be taking: Antihyperglycemics, Steroids, Adrenergics, others

Disqualifiers: Diabetes, Thyroid disease, Pregnancy, others

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

Compensation: Varies

Number of Visits: 2

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Background: Time restricted eating (TRE) is a form of fasting in which a person eats only during a set window of time, which is usually between 4 and 10 hours each day. Researchers want to know more about how TRE may affect health. Objective: To learn how TRE affects women with different body sizes. Eligibility: Healthy women aged 18 to 50 years. Design: Participants will have 2 visits: 1 screening visit and one 5-day stay in the clinic. Participants will fast before both visits. They will have a physical exam with blood tests. They will talk to a nutritionist about the foods they eat. They will lay under a clear hood for up to 45 minutes during a test that measures how many calories they burn while resting. Participants will keep a food diary for up to 7 days before their clinic stay. They will apply a continuous glucose monitor the day before they go to the clinic. This is a device that attaches to the skin of the stomach. They will wear this device throughout their clinic stay. All meals will be provided during the clinic stay. Participants will follow TRE on 3 days. They will answer survey questions and have tests during their stay, including: * DXA (dual energy X-ray absorptiometry) scan. Participants will lie on a padded table. Their body will be scanned to measure how much muscle, bone, fat, and other tissues they have. * Stable isotope tracer study. Small amounts of sugar and other substances will be given through a tube attached to a needle inserted into a vein in the arm. Blood samples will be collected.

Will I have to stop taking my current medications?

The trial requires that participants do not use certain medications, including those for blood sugar control, steroids, and medications affecting sleep or metabolism. If you are taking any of these, you may need to stop before joining the study.

Is time-restricted eating safe for humans?

Research suggests that time-restricted eating, where food is consumed within a specific time window each day, is generally safe for humans. A study on adults with obesity found no significant changes in adverse events or health markers over 12 weeks, indicating it can be a safe method for weight management. ^{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 hours during which you eat, rather than reducing the amount of food you consume. This approach aligns eating patterns with natural circadian rhythms, potentially improving metabolic health and aiding weight loss without the need for strict calorie counting. ^{3 4 6 7 8}

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

Research suggests that time-restricted eating (TRE), which involves eating within a specific time window each day, can safely help with weight loss in people with obesity. It may also improve body composition and metabolic health, making it a promising strategy for managing obesity and related health issues. ^{1 4 8 9 10}

Who Is on the Research Team?

Stephanie T Chung, M.D.

Principal Investigator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Are You a Good Fit for This Trial?

Healthy premenopausal women aged 18-50 with a BMI of either 18-24.9 or over 30, who are willing to follow the study's lifestyle guidelines and procedures for its duration. Exclusions include those with certain metabolic conditions, on specific medications affecting metabolism, heavy caffeine users, irregular sleep/eating patterns, recent weight fluctuations, competitive athletes, alcohol consumers exceeding three drinks daily, and tobacco/nicotine users.

Inclusion Criteria

BMI of 18-24.9 or >=30 kg/m^2

I am in good health overall.

Agreement to adhere to Lifestyle Considerations throughout study duration

Exclusion Criteria

I do not have immune, inflammatory, or metabolic conditions that could affect the study.

Inability to provide informed consent

Food allergies/intolerances or dietary patterns that would prohibit consumption of metabolic diet

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Clinic Stay

Participants stay in the clinic for 5 days, following a time restricted eating regimen and undergoing various tests and assessments.

5 days

1 visit (in-person, 5-day stay)

Follow-up

Participants are monitored for safety and effectiveness after the clinic stay, including assessment of ketone metabolism and immunoregulation.

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Conventional dietary regimen (12-hr, 9:30a-9:30p)
• Early Time-Restricted Eating

Trial Overview The trial is examining how early time-restricted eating (TRE), where participants eat only during a limited part of the day compared to a conventional diet spread over 12 hours affects ketone metabolism and immune function in women. It includes tests like DXA scans and stable isotope tracer studies during a five-day clinic stay.

How Is the Trial Designed?

Group I: Premenopausal women (lean and obese) Experimental Treatment 2 Interventions

Ages 18-50 yearsBMI 18.0-24.5 mg/k\^2 or BMI \> 30 mg/k\^2

Who Is Running the Clinical Trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Lead Sponsor

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

In a 12-week study involving 20 participants (17 women and 3 men), time-restricted eating (TRE) significantly reduced the eating window and led to weight loss, decreased fat mass, and reduced visceral fat compared to an unrestricted eating control group.

Participants in the TRE group experienced a 3.7% reduction in weight and an 11.1% reduction in visceral fat, demonstrating that TRE can be an effective strategy for weight management without changing physical activity or metabolic measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-Restricted Eating Effects on Body Composition and Metabolic Measures in Humans who are Overweight: A Feasibility Study. Chow, LS., Manoogian, ENC., Alvear, A., et al.[2020]

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]

Intermittent energy restriction (IER) was found to be a feasible and effective weight management strategy for adolescents aged 12-17 with obesity, leading to a significant reduction in BMI %95th percentile after 12 weeks (-5.6%) and maintained reductions at 26 weeks.

Participants reported IER as easy and pleasant to follow, indicating high acceptability, and the intervention also resulted in improvements in cardiovascular health markers, such as reduced carotid intima-media thickness and improved flow-mediated dilation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent Energy Restriction Is a Feasible, Effective, and Acceptable Intervention to Treat Adolescents with Obesity. Jebeile, H., Gow, ML., Lister, NB., et al.[2023]

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]

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]

Time-restricted eating (TRE), which limits food intake to 6 to 10 hours during the active part of the day, has been shown to improve metabolic health and glucose tolerance in various models, including humans.

Most research on TRE has focused on starting the eating window in the morning, but this paper highlights potential challenges and metabolic effects of delaying the eating window, suggesting that timing may be crucial for maximizing benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Will Delaying Breakfast Mitigate the Metabolic Health Benefits of Time-Restricted Eating? Heilbronn, LK., Regmi, P.[2021]

Time-restricted eating (TRE) is emerging as a promising strategy for treating obesity and related health issues, addressing the challenges of long-term adherence to traditional hypocaloric diets.

While TRE may help with weight loss and metabolic health through mechanisms like reduced caloric intake and improved eating behaviors, there are significant limitations in current research, including inconsistencies in clinical trials and a lack of long-term safety data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Time-restricted eating as a novel strategy for treatment of obesity and it's comorbid conditions]. Berkovskaya, MA., Gurova, OY., Khaykina, IA., et al.[2023]

In a pilot study of 50 participants with obesity over 12 weeks, time-restricted eating (TRE) led to a modest average weight loss of 2.6 kg, with greater weight loss observed in those who adhered to the regimen at least five days a week.

While TRE showed similar weight loss results compared to more complex weight management methods, it did not significantly impact blood pressure or lipid profiles, suggesting its primary benefit may be in weight management rather than metabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time restricted eating as a weight loss intervention in adults with obesity. Przulj, D., Ladmore, D., Smith, KM., 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]

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]

Citations

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

Time-Restricted Eating Effects on Body Composition and Metabolic Measures in Humans who are Overweight: A Feasibility Study. [2020]

2. China pubmed.ncbi.nlm.nih.gov

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

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

Intermittent Energy Restriction Is a Feasible, Effective, and Acceptable Intervention to Treat Adolescents with Obesity. [2023]

4. Canada pubmed.ncbi.nlm.nih.gov

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

5. United States 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. [2023]

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

Will Delaying Breakfast Mitigate the Metabolic Health Benefits of Time-Restricted Eating? [2021]

7. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Time-restricted eating as a novel strategy for treatment of obesity and it's comorbid conditions]. [2023]

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

Time restricted eating as a weight loss intervention in adults with obesity. [2021]

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

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

10. 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]