Time Restricted Eating for Weight Management
Study Details
Study Description
Brief Summary
Approximately 26% of Americans have obesity and prediabetes. These conditions greatly increase the risk for the development of type 2 diabetes. Innovative lifestyle strategies to treat obesity and prediabetes are critically needed. If the aims of this application are achieved, this study will be the first to show that time restricted feeding 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 time restricted feeding can be used as an effective non-pharmacological therapy to improve insulin sensitivity and decrease metabolic risk in this population group.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed 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, 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 8-hour Time restricted eating Ad libitum food intake from 12-8 pm every day Fasting from 8-12 pm every day (16-h fast) |
Other: 8-hour Time restricted eating
Ad libitum food intake from 12-8 pm every day Fasting from 8-12 pm every day (16-h fast)
|
| Experimental: Calorie restriction 25% energy restriction every day |
Other: Calorie restriction
25% energy restriction every day
|
| No Intervention: Control Usual diet |
Outcome Measures
Primary Outcome Measures
- Change from baseline to month 12 in body weight [Measured at month 0 and month 12]
Measured by an electronic scale
Secondary Outcome Measures
- Change from baseline to month 12 in fat mass and lean mass [Measured at month 0 and month 12]
Measured by DXA
- Change from baseline to month 12 in Insulin resistance [Measured at month 0 and month 12]
Measured as HOMA-IR
- Change from baseline to month 12 in Fasting glucose [Measured at month 0 and month 12]
Measured with a hexokinase reagent kit
- Change from baseline to month 12 in glucose [Measured at month 0 and month 12]
Measured by a continuous glucose monitor
- Change from baseline to month 12 in Fasting insulin [Measured at month 0 and month 12]
Measured as total immunoreactive insulin
- Change from baseline to month 12 in Blood pressure [Measured at month 0 and month 12]
Measured by a blood pressure cuff
- Change from baseline to month 12 in Plasma lipids [Measured at month 0 and month 12]
Measured by outside lab (Medstart, IN)
- Change from baseline to month 12 in heart rate [Measured at month 0 and month 12]
Measured by a blood pressure cuff
- Change from baseline to month 12 in inflammatory markers (TNF-apha, IL-6, IL-10, IL-B, hs-CRP) [Measured at month 0 and month 12]
Measured by ELISA
- Change from baseline to month 12 in oxidative stress [Measured at month 0 and month 12]
Measured by ELISA
- Change from baseline to month 12 in energy and nutrient intake [Measured at month 0 and month 12]
Measured by 7-day food record
- Change from baseline to month 12 in physical activity (steps/d) [Measured at month 0 and month 12]
Measured by pedometer
- Change from baseline to month 12 in the daily eating window [Measured at month 0 and month 12]
Measured by questionnaire (assesses the time the participant started and stopped eating each day)
- Change from baseline to month 12 in sleep quality [Measured at month 0 and month 12]
Measured by Pittsburgh Sleep Quality Index (PSQI), total score of 0-21. A PSQI total score greater than 5 indicates poor sleep quality.
- Change from baseline to month 12 in insomnia severity [Measured at month 0 and month 12]
Measured by Insomnia Severity Index (ISI), total score of 0-28. The total score for the ISI is interpreted as follows: no clinically significant insomnia (0-7), sub-threshold insomnia (8-14), moderate severity insomnia (15-21), and severe insomnia (22-28).
- Change from baseline to month 12 in risk of sleep apnea [Measured at month 0 and month 12]
Measured by Berlin Questionnaire, measures the presence or absence of sleep apnea
- Change from baseline to month 12 in mood [Measured at month 0 and month 12]
Measured by 36-Item Short Form Survey (SF-36), total score 0-100. Higher scores mean worse outcome.
- Change from baseline to month 12 in adverse events [Measured at month 0 and month 12]
Measured by questionnaire
- Change from baseline to month 12 in appetite [Measured at month 0 and month 12]
Measured by Visual analog scale (VAS). Scored from 0-100. Higher score means higher appetite.
- Change from baseline to month 12 in eating disorder symptoms [Measured at month 0 and month 12]
Measured by Multifactorial Assessment of Eating Disorders Symptoms (MAEDS), total score of 0-100, Higher scores mean worse outcome.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age between 18 to 70 years old
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Sedentary or lightly active
Exclusion Criteria:
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Diabetic (fasting glucose: >126 mg/dl)
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History of alcohol dependance (score >20 from Alcohol and Health Questionnaire)
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Are not weight stable for 3 months prior to the beginning of study (weight gain or loss > 4 kg)
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Are not able to keep a food diary or activity log for 7 consecutive days during screening
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Are taking drugs that influence study outcomes (weight loss, glucose-lowering - Are perimenopausal or have an irregular menstrual cycle (menses that does not appear every 27-32 days)
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Are pregnant, or trying to become pregnant
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Do not have a WiFi internet connection at home
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Are night shift workers
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Are smokers
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Illinois Chicago | Chicago | Illinois | United States | 60612 |
Sponsors and Collaborators
- University of Illinois at Chicago
Investigators
- Principal Investigator: Krista Varady, PhD, University of Illinois Chicago
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2020-1512