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?

Time-restricted Eating (TRE) is a dietary approach that limits food intake to 4 - 12-hour windows without intentionally altering diet quality. TRE has several benefits including modest reductions in body weight and fat mass, improved glucose control, and reduced inflammatory markers. While research supports the metabolic and weight related benefits of TRE, there is limited evidence of its effects on physical activity (PA), sedentary behavior (SB) and sleep - the core components of 24-hour Activity Cycle (24-HAC), which is a holistic framework that integrates the three health-related activities. TRE research has largely focused on clinical populations, leaving its feasibility and adherence in healthy younger adults understudied. Within this group, college students' misaligned circadian rhythms and unpredictable schedules may make adherence to TRE challenging, highlighting the need for research on its practicality in this group. These outcomes are also particularly important to investigate in women, considering that SB is more prevalent among college-aged women (69%) compared to men (46%). To address these issues, we will conduct a three-week intervention to study the effects of TRE on the 24-HAC outcomes. College aged women will be screened and enrolled, then assigned to either a control or TRE group. Participants in the TRE group will self-select the timing of their 8-hour eating window which they will maintain throughout the study (with compliance on at least six days per week needed to be considered adherent). The control group will receive a basic nutrition education at the start of the study and will have no restriction on eating times. 24 HAC behaviors will be measured continuously for one-week of baseline measurement and throughout the intervention by wrist-worn ActiGraph GT9X monitors. Participants will also record the timing of their first and last meal each day and receive periodic reminders to report their hunger and satiety ratings using visual analog scales.

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?

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

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+