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Completed

NCT Number: NCT04692532

Time Restricted Eating for Weight Management

A 12-month randomized, controlled, parallel-arm trial, divided into 2 consecutive periods: (1) 6-month weight loss period; and (2) 6-month weight maintenance, will be implemented. Adults with obesity will be randomized to 1 of 3 groups: (1) 8h-TRE, ad libitum food intake from 12pm to 8 pm, fasting from 8 pm to 12 pm daily, (2) CR, 25% energy restriction every day; or 3) control, ad libitum food intake daily, eating within more than 10 hours per day.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Illinois Chicago

Chicago, Illinois, 60612, United States

About this study

Time restricted eating (TRE) has become a popular weight loss regimen. The sudden rise in popularity of TRE is mostly likely due to is its sheer simplicity, and the fact that it does not require individuals to count calories in order to lose weight. Participants are simply asked to consume all food within a specified time frame and fast with energy free beverages for the remaining hours of the day. Evidence shows that when people with obesity limit their eating window to 6 to 8 hours per day, they naturally reduce energy intake by 350-500 calories. From a clinical standpoint, these findings are paramount. One of the main reasons for subject attrition with traditional dieting, i.e. daily calorie restriction (CR), is frustration with having to count calories every day. TRE regimens are able to side-step this requirement by allowing participants to simply "watch the clock" instead of monitoring calories, while still producing significant weight loss and metabolic health improvements. This feature of TRE has the potential to improve long-term adherence to the diet, and in turn produce lasting weight control in adults with obesity.

Accordingly, we conducted a one-year, randomized, controlled trial to compare the effects of late TRE (eating all food between 12:00 pm to 8:00 pm, without calorie counting), versus CR (25% energy restriction daily), and a control group eating over a period of 10 or more hours, on body weight and metabolic risk factors in a diverse group of American adults with obesity. We hypothesized that the TRE group would achieve greater weight loss, and experience more pronounced improvements in insulin sensitivity during the 6-month weight loss phase, compared to CR and control participants. We also hypothesized that the TRE group would better maintain their weight loss and sustain their improvements in insulin sensitivity during the 6-month weight maintenance phase, when compared to the CR and control participants.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18 to 65 years old
  • BMI between 30 and 50 kg/m2
  • Sedentary or lightly active (<60 minutes/week of light activity for the 3 months prior to the study)

Exclusion criteria

  • • Type 1 DM or Type 2 DM
  • History of eating disorders (anorexia, bulimia, or binge eating disorder)
  • Are not weight stable for 3 months prior to the beginning of study (weight gain or loss > 4 kg)
  • Are not able to keep a food diary or activity log for 7 consecutive days during screening
  • Are taking drugs that influence study outcomes (weight loss, glucose-lowering medications)
  • Are perimenopausal or have an irregular menstrual cycle (menses that does not appear every 27-32 days)
  • Are eating within less than a 10-hour window at baseline
  • Are pregnant, or trying to become pregnant
  • Are night shift workers
  • Are smokers

Treatment and study plan

8-hour Time restricted eating

Other

Ad libitum food intake from 12-8 pm every day Fasting from 8-12 pm every day (16-h fast)

Calorie Restriction

Other

25% energy restriction every day

Primary outcomes

  1. Change in Body Weight

    Time frame: Measured at month 0 and 12

    Measured by an electronic scale

Secondary outcomes

  1. Change in Fat Mass

    Time frame: Measured at month 0 and 12

    Measured by DXA

  2. Change in Insulin Resistance

    Time frame: Measured at month 0 12

    Measured by Homeostatic Model Assessment of Insulin Resistance (HOMA-IR). Values above 2.5 generally considered an indicator of insulin resistance. Higher values indicate greater insulin resistance while lower values indicate lower insulin resistance. HOMA-IR = [glucose (mmol/L) × insulin (μU/L)]/22.5.

  3. Change in Insulin Sensitivity

    Time frame: Measured at month 0 and 12

    Measured by Quantitative Insulin Sensitivity Check Index (QUICKI). QUICKI calculated as = 1/[log (fasting insulin, U/ml) + log (fasting glucose, mg/dl)]. Higher scores (typically > 0.45) indicate high insulin sensitivity. Lower scores (generally ≤ 0.33 or 0.34) indicate decreased insulin sensitivity and an increased risk for insulin resistance or type 2 diabetes.

  4. Change in Fasting Glucose

    Time frame: Measured at month 0 and 12

    Measured by a commercial lab (Medstar, IL)

  5. Change in HbA1c

    Time frame: Measured at month 0 and 12

    Measured by a commercial lab (Medstar, IL)

  6. Change in Fasting Insulin

    Time frame: Measured at month 0 and 12

    Measured by a commercial lab (Medstar, IL)

  7. Change in Systolic Blood Pressure

    Time frame: Measured at month 0 and 12

    Measured by a blood pressure cuff

  8. Change in Diastolic Blood Pressure

    Time frame: Measured at month 0 and 12

    Measured by a blood pressure cuff

  9. Change in LDL Cholesterol

    Time frame: Measured at month 0 and 12

    Measured by a commercial lab (Medstar, IL)

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Collaborators

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

Registry information

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jan 5, 2021
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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