Effects of Timed Restricted Eating on Body Composition, Metabolism, and Cardiovascular Health

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of South Alabama

About this trial

This study is looking at whether eating all meals within a 6-hour window each day (called Time-Restricted Eating, or TRE) can improve body composition, metabolism, heart health, and blood markers over 12 weeks. The study also wants to find out whether allowing participants to eat normally on weekends makes the diet easier to follow long-term.

Adults aged 18-65 with a BMI of 26 or higher who do not have heart disease or diabetes may be eligible. Participants will be randomly placed into one of two groups: (1) TRE every day for 12 weeks, or (2) TRE on weekdays with normal eating on weekends. All participants will visit the lab twice - once at the start and once at the end - for measurements of body fat, resting calorie burn, heart function, and blood tests. Between visits, participants will log their meals and steps at home and check in with the research team every two weeks.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Between 18 and 65 years of age

Body mass index (BMI) of 26 kg/m² or higher (overweight or obese range)

Physically inactive, defined as 150 minutes or less of moderate-intensity physical activity per week for the 3 months prior to enrollment

No previous history of cardiovascular disease or Type 1 or Type 2 Diabetes Mellitus

Disqualifiers

Younger than 18 or older than 65 years of age

BMI below 26 kg/m²

More than 150 minutes per week of moderate-intensity physical activity in the past 3 months

History of cardiovascular disease or Type 1 or Type 2 Diabetes Mellitus

Trial design

Design model

Parallel

Treatments tested in this trial

  • Time-Restricted Eating (TRE)

    Behavioral

    Participants consume all calorie-containing food and beverages within a 6-hour afternoon eating window (e.g., 2-8 pm) every day for 12 weeks. Outside of this window, only non-caloric beverages (water, black coffee, plain tea) are permitted. No changes to food quality or caloric targets are prescribed.

  • Time-Restricted Eating with Intermittent Energy Restriction (TRE+IER)

    Behavioral

    Participants follow the same 6-hour afternoon eating window Monday through Friday. On Saturday and Sunday, participants return to their habitual, unrestricted eating pattern (ad libitum intake). This modified approach introduces periodic weekend diet breaks to assess whether reduced dietary rigidity improves long-term adherence while maintaining a clinically meaningful weekly calorie deficit.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: TRE OnlyExperimental treatment 1 intervention
Group B: TRE + Weekend Ad Libitum (TRE+IER)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Body Fat Percentage

Change in body fat percentage assessed via the 4-compartment (4C) model, combining DXA-derived bone mineral content, air displacement plethysmography (BodPod) body volume, bioimpedance spectroscopy (BIS) total body water, and calibrated body mass, using the Wang equation.

Time frame
Baseline and 12 weeks

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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