Time Restricted Feeding (4-hour Versus 6-hour) for Weight Loss in Obese Adults
1 other identifier
interventional
82
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable obesity
Started Feb 2019
Shorter than P25 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2019
CompletedFirst Submitted
Initial submission to the registry
March 4, 2019
CompletedFirst Posted
Study publicly available on registry
March 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2019
CompletedJune 24, 2022
June 1, 2022
9 months
March 4, 2019
June 19, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline to week 8 in body weight
Measured by an electronic scale
Measured at week 1 and 8
Secondary Outcomes (17)
Change from baseline to week 8 in body composition
Measured at week 1 and 8
Change from baseline to week 8 in Insulin resistance
Measured at week 1 and 8
Change from baseline to week 8 in Fasting glucose
Measured at week 1 and 8
Change from baseline to week 8 in Fasting insulin
Measured at week 1 and 8
Change from baseline to week 8 in Blood pressure
Measured at week 1 and 8
- +12 more secondary outcomes
Study Arms (3)
4-hour Time restricted feeding
EXPERIMENTAL4-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.
Control
NO INTERVENTIONControls 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-hour Time restricted feeding
EXPERIMENTAL6-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.
Interventions
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)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Illinois Chicago
Chicago, Illinois, 60612, United States
Related Publications (2)
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.
PMID: 34478825DERIVEDCienfuegos 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.
PMID: 32673591DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Nutrition
Study Record Dates
First Submitted
March 4, 2019
First Posted
March 8, 2019
Study Start
February 1, 2019
Primary Completion
October 30, 2019
Study Completion
October 30, 2019
Last Updated
June 24, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share