36 Participants NeededMy employer runs this trial

Time Restricted Eating for Intermittent Fasting

(DAWG-TREAT Trial)

TT
Overseen ByTejaswi Tamilmani Saraswathi, MS
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the impact of time-restricted eating (TRE) on daily activities such as physical activity, sedentary behavior, and sleep, which together form the 24-hour Activity Cycle. TRE involves consuming all meals within an 8-hour window each day. The study aims to assess its effects on these daily activities in college-aged women. Participants will be divided into two groups: one will follow TRE, and the other will maintain their usual eating habits. Female students from the University of Georgia who are enrolled full-time and have no major health issues may be suitable for this trial. As an unphased trial, it offers participants the chance to contribute to groundbreaking research on lifestyle and health.

Will I have to stop taking my current medications?

The trial excludes participants who use nicotine, thyroid medications, antidepressants, anti-anxiety medications, or melatonin, so if you are taking any of these, you would not be eligible to participate.

What prior data suggests that Time Restricted Eating is safe?

Research has shown that time-restricted eating (TRE), which involves eating only during specific hours each day, is generally safe for most people. Studies have found that TRE can aid in weight loss and enhance insulin function, a hormone that regulates blood sugar.

In trials, participants followed TRE schedules without major issues. Serious side effects are rare, though some individuals might experience increased hunger or mild headaches initially. These effects typically subside as the body adjusts to the new eating pattern.

Overall, TRE is considered safe and well-tolerated for healthy adults. It offers a promising approach for individuals to improve their health by adopting better eating habits.12345

Why are researchers excited about this trial?

Researchers are excited about the Time Restricted Eating (TRE) trial because it explores a unique approach to intermittent fasting by focusing on an 8-hour window of eating, which is self-selected by participants. Unlike traditional diets that can be restrictive and require calorie counting, TRE emphasizes the timing of food intake rather than what is eaten. This method might offer a more sustainable and less rigid way to manage weight and metabolic health. By aligning eating patterns with the body's natural circadian rhythms, researchers hope to uncover benefits such as improved metabolism and better overall health outcomes.

What evidence suggests that Time Restricted Eating might be an effective treatment for improving the 24-hour Activity Cycle?

Research has shown that time-restricted eating (TRE), where eating occurs only during certain hours, offers several health benefits. Studies have found that TRE can lead to modest weight loss, a smaller waist, and an improved body mass index (BMI). It also helps reduce body fat and enhances blood sugar control. TRE is generally safe and well-received, with participants in various trials experiencing positive changes in body shape and energy levels. This trial will compare an 8-hour self-selected TRE schedule with a control group following normal eating patterns. While the benefits of TRE are clear, limited information exists on its effects on physical activity, sitting habits, and sleep, particularly in young adults.45678

Who Is on the Research Team?

MD

Michael D Schmidt, Ph.D.

Principal Investigator

University of Georgia

Are You a Good Fit for This Trial?

This trial is for female college students at the University of Georgia, ages 18-26, who are generally healthy. Those with chronic diseases, eating disorders, certain medication use, high alcohol intake, pregnancy, sleep disorders, or recent special diets cannot participate.

Inclusion Criteria

I am a female college or graduate student.
Enrolled full-time at University of Georgia
I am between 18 and 26 years old.

Exclusion Criteria

I have a chronic disease like diabetes, cancer, heart, thyroid, liver, or bowel issues.
I have an eating disorder, diagnosed or not.
I use nicotine, thyroid medicine, antidepressants, anti-anxiety meds, or melatonin.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Baseline Measurement

Participants' 24-Hour Activity Cycle behaviors are measured using ActiGraph GT9X monitors

1 week
Continuous monitoring

Intervention

Participants in the TRE group follow an 8-hour eating window; control group receives basic nutrition education

3 weeks
Continuous monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

  • Time Restricted Eating

Trial Overview

The study compares time-restricted eating (eating within an 8-hour window) to no eating schedule change in college-aged women over three weeks. It looks at how this affects physical activity, sedentary behavior, and sleep using wearable monitors.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Time Restricted Eating (TRE)Experimental Treatment1 Intervention
Group II: ControlExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Georgia

Lead Sponsor

Trials
109
Recruited
43,500+

Citations

Time-restricted eating: What we know and where the field is ...

Trials with an eating window of 6 to 10 hours found that TRE was generally safe and well received and that it had a variety of health benefits. Health benefits ...

Time-restricted eating improves health because of energy ...

The results showed that TRE led to modest weight loss, lower waist circumference and energy deficits. TRE also improved body mass index, fat ...

Effect of Time-Restricted Eating on Weight Loss in Adults ...

In a 6-month randomized clinical trial involving 75 adults with T2D, TRE was more effective for weight loss (−3.6%) than CR (−1.8%) compared with controls.

How Does Early, Midday, and Late Time-Restricted Eating ...

There were 18 prespecified outcomes in our present study: 1) BW (kg), 2) BMI (kg/m2), 3) fat%, 4) fat mass (kg), 5) lean body mass (LBM) (kg), 6 ...

Effects of timing and eating duration of time restricted ... - PMC

Compared with usual diets, overall time restricted eating significantly improved body weight, body mass index, fat mass, waist circumference, ...

What are the effects of time‐restricted eating upon metabolic ...

Fasting promotes organ‐specific changes to improve flexibility of fuel utilization, fatty acid and ketone oxidation, insulin sensitivity, and ...

Effect of 8-Hour Time-Restricted Eating (16/8 TRE) on Glucose ...

Based upon our overall findings, most of the population showed consistent results in glucose metabolism, which indicates that 16/8 TRE may be ...

Time-Restricted Eating in Metabolic and Clinical Health

TRE protocols (e.g., 16:8, 14:10) improved body composition, insulin sensitivity, lipid profiles, and inflammation. Evidence also points to ...