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

Primary Purpose

Obesity, Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Time restricted feeding
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Illinois Chicago

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Experimental

Arm Label

4-hour Time restricted feeding

Control

6-hour Time restricted feeding

Arm Description

4-h TRF subjects will consume food ad libitum between 3pm and 7pm (4-h feeding window), and refrain from eating and drinking caloric beverages from 7pm to 3pm (20-h fasting window) each day. These subjects will not be instructed to limit/monitor energy intake during the feeding window. Subjects will be encouraged to drink plenty of water during the fasting period.

Controls will be instructed to maintain their weight throughout the trial, and not to change eating or physical activity habits. Controls will visit the research center at the same frequency as the TRF groups (for outcome measurements).

6-h TRF subjects will consume food ad libitum between 1pm and 7pm (6-h feeding window), and refrain from eating and drinking caloric beverages from 7pm to 1pm (18-h fasting window) each day. These subjects will not be instructed to limit/monitor energy intake during the feeding window. Subjects will be encouraged to drink plenty of water during the fasting period.

Outcomes

Primary Outcome Measures

Change from baseline to week 8 in body weight
Measured by an electronic scale

Secondary Outcome Measures

Change from baseline to week 8 in body composition
Measured by DXA
Change from baseline to week 8 in Insulin resistance
Measured as HOMA-IR
Change from baseline to week 8 in Fasting glucose
Measured with a hexokinase reagent kit
Change from baseline to week 8 in Fasting insulin
Measured as total immunoreactive insulin
Change from baseline to week 8 in Blood pressure
Measured by a blood pressure cuff
Change from baseline to week 8 in adverse events
Measured by questionnaire
Change from baseline to week 8 in plasma lipids
Measured by outside lab (Medstart, IN)
Change from baseline to week 8 in heart rate
Measured by a blood pressure cuff
Change from baseline to week 8 in inflammatory markers (TNF-a, IL-6)
Measured by ELISA
Change from baseline to week 8 in oxidative stress (8-isoprostane)
Measured by ELISA
Change from baseline to week 8 in calorie and macronutrient intake
Measured by food record
Change from baseline to week 8 in physical activity (steps/d)
Measured by activity monitor
Change from baseline to week 8 in diet adherence
Measured by a questionnaire
Change from baseline to week 8 in sleep quality
Measured by a questionnaire
Change from baseline to week 8 in insomnia severity
Measured by a questionnaire
Change from baseline to week 8 in risk of sleep apnea
Measured by a questionnaire
Change from baseline to week 8 in sex steroid levels (estrogen, androgens, sex hormone binding globulin)
Measured by a ELISA

Full Information

First Posted
March 4, 2019
Last Updated
June 19, 2022
Sponsor
University of Illinois at Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT03867773
Brief Title
Time Restricted Feeding (4-hour Versus 6-hour) for Weight Loss in Obese Adults
Official Title
Time Restricted Feeding (4-hour Versus 6-hour) for Weight Loss in Obese Adults
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
October 30, 2019 (Actual)
Study Completion Date
October 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Diabetes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
4-hour Time restricted feeding
Arm Type
Experimental
Arm Description
4-h TRF subjects will consume food ad libitum between 3pm and 7pm (4-h feeding window), and refrain from eating and drinking caloric beverages from 7pm to 3pm (20-h fasting window) each day. These subjects will not be instructed to limit/monitor energy intake during the feeding window. Subjects will be encouraged to drink plenty of water during the fasting period.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Controls will be instructed to maintain their weight throughout the trial, and not to change eating or physical activity habits. Controls will visit the research center at the same frequency as the TRF groups (for outcome measurements).
Arm Title
6-hour Time restricted feeding
Arm Type
Experimental
Arm Description
6-h TRF subjects will consume food ad libitum between 1pm and 7pm (6-h feeding window), and refrain from eating and drinking caloric beverages from 7pm to 1pm (18-h fasting window) each day. These subjects will not be instructed to limit/monitor energy intake during the feeding window. Subjects will be encouraged to drink plenty of water during the fasting period.
Intervention Type
Behavioral
Intervention Name(s)
Time restricted feeding
Intervention Description
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 Outcome Measure Information:
Title
Change from baseline to week 8 in body weight
Description
Measured by an electronic scale
Time Frame
Measured at week 1 and 8
Secondary Outcome Measure Information:
Title
Change from baseline to week 8 in body composition
Description
Measured by DXA
Time Frame
Measured at week 1 and 8
Title
Change from baseline to week 8 in Insulin resistance
Description
Measured as HOMA-IR
Time Frame
Measured at week 1 and 8
Title
Change from baseline to week 8 in Fasting glucose
Description
Measured with a hexokinase reagent kit
Time Frame
Measured at week 1 and 8
Title
Change from baseline to week 8 in Fasting insulin
Description
Measured as total immunoreactive insulin
Time Frame
Measured at week 1 and 8
Title
Change from baseline to week 8 in Blood pressure
Description
Measured by a blood pressure cuff
Time Frame
Measured at week 1 and 8
Title
Change from baseline to week 8 in adverse events
Description
Measured by questionnaire
Time Frame
Measured weekly from baseline to week 8
Title
Change from baseline to week 8 in plasma lipids
Description
Measured by outside lab (Medstart, IN)
Time Frame
Measured at week 1 and 8
Title
Change from baseline to week 8 in heart rate
Description
Measured by a blood pressure cuff
Time Frame
Measured at week 1 and 8
Title
Change from baseline to week 8 in inflammatory markers (TNF-a, IL-6)
Description
Measured by ELISA
Time Frame
Measured at week 1 and 8
Title
Change from baseline to week 8 in oxidative stress (8-isoprostane)
Description
Measured by ELISA
Time Frame
Measured at week 1 and 8
Title
Change from baseline to week 8 in calorie and macronutrient intake
Description
Measured by food record
Time Frame
Measured at week 1 and 8
Title
Change from baseline to week 8 in physical activity (steps/d)
Description
Measured by activity monitor
Time Frame
Measured at week 1 and 8
Title
Change from baseline to week 8 in diet adherence
Description
Measured by a questionnaire
Time Frame
Measured weekly from baseline to week 8
Title
Change from baseline to week 8 in sleep quality
Description
Measured by a questionnaire
Time Frame
Measured at week 1 and 8
Title
Change from baseline to week 8 in insomnia severity
Description
Measured by a questionnaire
Time Frame
Measured at week 1 and 8
Title
Change from baseline to week 8 in risk of sleep apnea
Description
Measured by a questionnaire
Time Frame
Measured at week 1 and 8
Title
Change from baseline to week 8 in sex steroid levels (estrogen, androgens, sex hormone binding globulin)
Description
Measured by a ELISA
Time Frame
Measured at week 1 and 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
University of Illinois Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34478825
Citation
Cienfuegos S, Gabel K, Kalam F, Ezpeleta M, Lin S, Varady KA. Changes in body weight and metabolic risk during time restricted feeding in premenopausal versus postmenopausal women. Exp Gerontol. 2021 Oct 15;154:111545. doi: 10.1016/j.exger.2021.111545. Epub 2021 Aug 31.
Results Reference
derived
PubMed Identifier
32673591
Citation
Cienfuegos S, Gabel K, Kalam F, Ezpeleta M, Wiseman E, Pavlou V, Lin S, Oliveira ML, Varady KA. Effects of 4- and 6-h Time-Restricted Feeding on Weight and Cardiometabolic Health: A Randomized Controlled Trial in Adults with Obesity. Cell Metab. 2020 Sep 1;32(3):366-378.e3. doi: 10.1016/j.cmet.2020.06.018. Epub 2020 Jul 15.
Results Reference
derived

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

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