Time Restricted Eating for Weight Management
Last updated on July 2021Recruitment
- Recruitment Status
- Enrolling by invitation
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Obesity
- Prediabetes
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 70 years
- Gender
- Both males and females
Description
Background: Intermittent fasting has greatly increased in popularity over the past decade owing to its ability to produce clinically significant weight loss. The most popular form of intermittent fasting is time restricted feeding (TRF). TRF typically involves confining the eating window to 8-10 h, ...
Background: Intermittent fasting has greatly increased in popularity over the past decade owing to its ability to produce clinically significant weight loss. The most popular form of intermittent fasting is time restricted feeding (TRF). TRF typically involves confining the eating window to 8-10 h, and fasting for the remaining hours of the day. During the eating window, individuals are not required to count calories or monitor food intake in any way. Despite its growing popularity, only three human trials have examined the effect of TRF on body weight. While these preliminary studies show promise for TRF as a weight loss intervention, all of these previous trials are limited by short duration (2-4 months), the lack of a control group, and no comparison to traditional dieting approaches (daily calorie restriction (CR)). The present study will be the first long-term trial (48-weeks) to compare the effect of TRF to daily CR for weight management and improved glycemic control in individuals with obesity. Hypotheses: The present proposal will test the following hypotheses: (Hyp1) The TRF group will be more adherent with the intervention versus CR, which will result in greater energy restriction, weight loss and weight loss maintenance; (Hyp2) The TRF group will experience greater improvements in insulin sensitivity, insulin resistance, HbA1c and other metabolic disease variables (fasting insulin, triglycerides, LDL cholesterol, and blood pressure) versus CR; (Hyp3) The TRF group will experience greater improvements in markers of inflammation (TNF-alpha, IL-6, IL-B, IL-10, hs-CRP) and oxidative stress (8-isoprostane, 4-hydroxynonenal adducts, protein carbonyls, and nitrotyrosine) versus CR. Methods: A 48-week randomized, controlled, parallel-arm trial, divided into 2 consecutive periods: (1) 24-week weight loss period; and (2) 24-week weight maintenance, will be implemented. Adults with obesity (n = 300) will be randomized to 1 of 3 groups: (1) 8h-TRF (n = 100) ad libitum food intake from 12pm to 8 pm, fasting from 8 pm to 12 pm daily, (2) CR (n = 100), 25% energy restriction every day; or 3) control (n = 100), ad libitum food intake daily with no meal timing restrictions. Significance: If the aims of this application are achieved, this study will be the first to show that TRF can be implemented as an alternative to traditional dieting (i.e. daily calorie restriction) for long-term weight management. This study will also show that TRF can be used as an effective non-pharmacological therapy to improve insulin sensitivity and decrease metabolic risk factors in individuals with obesity.
Tracking Information
- NCT #
- NCT04692532
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Krista Varady, PhD University of Illinois Chicago