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Clinical Trial 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 (n = 150) will be randomized to 1 of 3 groups: (1) 4-h TRF (n = 50), (2) 6-h TRF (n = 50), or a no-intervention control group (n=50). This study will be the first randomized controlled trial of 4-h versus 6-h TRF, and will show that the 4-h TRF diet produces greater improvements in body weight, body composition, metabolic disease risk factors, sleep, and inflammation when compared to the 6-h TRF diet.


Clinical Trial 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), sleep, and inflammatory markers. 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 and body composition 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; AIM 3: To compare the effects of 4-h versus 6-h TRF on sleep quality and duration in adults with obesity; AIM 4: To compare the effects of 4-h versus 6-h TRF on inflammatory markers. 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 (n = 150) will be randomized to 1 of 3 groups: (1) 4-h TRF (n = 50), (2) 6-h TRF (n = 50), or a no-intervention control group (n=50). This study will be the first randomized controlled trial of 4-h versus 6-h TRF, and will show that the 4-h TRF diet produces greater improvements in body weight, body composition, metabolic disease risk factors, sleep, and inflammation when compared to the 6-h TRF diet. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03867773
Study type Interventional
Source University of Illinois at Chicago
Contact
Status Enrolling by invitation
Phase N/A
Start date March 1, 2019
Completion date September 1, 2019

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