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Completed

NCT Number: NCT03867773

Time Restricted Feeding (4-hour Versus 6-hour) for Weight Loss in Obese Adults

The aims of this proposal are to compare the effects of 4-h versus 6-h time restricted feeding (TRF) on body weight and metabolic disease risk factors in adults with obesity. To test the study objectives, a 10-week randomized, controlled, parallel-arm trial, divided into 2 consecutive periods: (1) 2-week baseline period; and (2) 8-week TRF weight loss period, will be implemented. Obese subjects will be randomized to 1 of 3 groups: (1) 4-h TRF, (2) 6-h TRF, or a no-intervention control group. This study will be the first randomized controlled trial to compare 4-h versus 6-h TRF.

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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

Modest weight loss of 5-10% is sufficient to reduce metabolic disease risk in obese individuals. The first line of therapy prescribed for weight loss is daily calorie restriction (CR; 25% restriction every day). However, adherence to CR greatly diminishes after 4-6 weeks, due to subject frustration with constantly having to count calories and never being able to eat freely. In light of these issues with CR, another approach that limits timing of food intake, instead of number of calories consumed, has been developed. This strategy is termed time restricted feeding (TRF), and involves confining the period of food intake to 8 h/d (10 am to 6 pm) without calorie counting. Preliminary findings of 8-h TRF demonstrate modest weight loss and blood pressure reductions after 12 weeks. What remains unknown however, is whether shorter feeding windows during TRF (such as 4-h or 6-h feeding windows) can produce even greater weight loss in obese adults. Also of interest, is the impact of these shorter feeding windows on metabolic disease risk indicators (such as plasma lipids, blood pressure, and insulin resistance, inflammation and oxidative stress). Accordingly, the aims of this proposal are: AIM 1: To compare the effects of 4-h versus 6-h time restricted feeding (TRF) on body weight in adults with obesity; AIM 2: To compare the effects of 4-h versus 6-h TRF on metabolic disease risk factors in adults with obesity. To test the study objectives, a 10-week randomized, controlled, parallel-arm trial, divided into 2 consecutive periods: (1) 2-week baseline period; and (2) 8-week TRF weight loss period, will be implemented. Obese subjects will be randomized to 1 of 3 groups: (1) 4-h TRF, (2) 6-h TRF, or a no-intervention control group. This study will be the first randomized controlled trial to compare 4-h versus 6-h TRF on body weight and metabolic disease risk markers.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male or female;
  • body mass index (BMI) between 30.0 and 49.9 kg/m2;
  • age between 18 and 65 years; sedentary (light exercise less than 1 h per week) or moderately active (moderate exercise 1 to 2 h per week);
  • weight stable for >3 months prior to the beginning of the study (gain or loss <4 kg);
  • able to give written informed consent

Exclusion criteria

  • Smoker; diabetic;
  • taking weight loss medications;
  • taking medication that requires eating food before (or with) the medication; history of eating disorders;
  • night-shift workers;
  • perimenopausal;
  • pregnant women

Treatment and study plan

Time restricted feeding

Behavioral

TRF subjects will consume food ad libitum during the feeding window (4-h or 6-h window), and refrain from eating during the fasting window (20-h or 18-h window)

Primary outcomes

  1. Change from baseline to week 8 in body weight

    Time frame: Measured at week 1 and 8

    Measured by an electronic scale

Secondary outcomes

  1. Change from baseline to week 8 in body composition

    Time frame: Measured at week 1 and 8

    Measured by DXA

  2. Change from baseline to week 8 in Insulin resistance

    Time frame: Measured at week 1 and 8

    Measured as HOMA-IR

  3. Change from baseline to week 8 in Fasting glucose

    Time frame: Measured at week 1 and 8

    Measured with a hexokinase reagent kit

  4. Change from baseline to week 8 in Fasting insulin

    Time frame: Measured at week 1 and 8

    Measured as total immunoreactive insulin

  5. Change from baseline to week 8 in Blood pressure

    Time frame: Measured at week 1 and 8

    Measured by a blood pressure cuff

  6. Change from baseline to week 8 in adverse events

    Time frame: Measured weekly from baseline to week 8

    Measured by questionnaire

  7. Change from baseline to week 8 in plasma lipids

    Time frame: Measured at week 1 and 8

    Measured by outside lab (Medstart, IN)

  8. Change from baseline to week 8 in heart rate

    Time frame: Measured at week 1 and 8

    Measured by a blood pressure cuff

  9. Change from baseline to week 8 in inflammatory markers (TNF-a, IL-6)

    Time frame: Measured at week 1 and 8

    Measured by ELISA

  10. Change from baseline to week 8 in oxidative stress (8-isoprostane)

    Time frame: Measured at week 1 and 8

    Measured by ELISA

  11. Change from baseline to week 8 in calorie and macronutrient intake

    Time frame: Measured at week 1 and 8

    Measured by food record

  12. Change from baseline to week 8 in physical activity (steps/d)

    Time frame: Measured at week 1 and 8

    Measured by activity monitor

  13. Change from baseline to week 8 in diet adherence

    Time frame: Measured weekly from baseline to week 8

    Measured by a questionnaire

  14. Change from baseline to week 8 in sleep quality

    Time frame: Measured at week 1 and 8

    Measured by a questionnaire

  15. Change from baseline to week 8 in insomnia severity

    Time frame: Measured at week 1 and 8

    Measured by a questionnaire

  16. Change from baseline to week 8 in risk of sleep apnea

    Time frame: Measured at week 1 and 8

    Measured by a questionnaire

  17. Change from baseline to week 8 in sex steroid levels (estrogen, androgens, sex hormone binding globulin)

    Time frame: Measured at week 1 and 8

    Measured by a ELISA

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 8, 2019
Registry last updated
Jun 24, 2022

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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