Time Restricted Eating for Weight Management

Study Overview
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Brief Summary
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A 12-month randomized, controlled, parallel-arm trial, divided into 2 consecutive periods: (1) 6-month weight loss period; and (2) 6-month weight maintenance, will be implemented. Adults with obesity will be randomized to 1 of 3 groups: (1) 8h-TRE, ad libitum food intake from 12pm to 8 pm, fasting from 8 pm to 12 pm daily, (2) CR, 25% energy restriction every day; or 3) control, ad libitum food intake daily, eating within more than 10 hours per day.

Detailed Description
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Time restricted eating (TRE) has become a popular weight loss regimen. The sudden rise in popularity of TRE is mostly likely due to is its sheer simplicity, and the fact that it does not require individuals to count calories in order to lose weight. Participants are simply asked to consume all food within a specified time frame and fast with energy free beverages for the remaining hours of the day. Evidence shows that when people with obesity limit their eating window to 6 to 8 hours per day, they naturally reduce energy intake by 350-500 calories. From a clinical standpoint, these findings are paramount. One of the main reasons for subject attrition with traditional dieting, i.e. daily calorie restriction (CR), is frustration with having to count calories every day. TRE regimens are able to side-step this requirement by allowing participants to simply watch the clock instead of monitoring calories, while still producing significant weight loss and metabolic health improvements. This feature of TRE has the potential to improve long-term adherence to the diet, and in turn produce lasting weight control in adults with obesity. Accordingly, we conducted a one-year, randomized, controlled trial to compare the effects of late TRE (eating all food between 12:00 pm to 8:00 pm, without calorie counting), versus CR (25% energy restriction daily), and a control group eating over a period of 10 or more hours, on body weight and metabolic risk factors in a diverse group of American adults with obesity. We hypothesized that the TRE group would achieve greater weight loss, and experience more pronounced improvements in insulin sensitivity during the 6-month weight loss phase, compared to CR and control participants. We also hypothesized that the TRE group would better maintain their weight loss and sustain their improvements in insulin sensitivity during the 6-month weight maintenance phase, when compared to the CR and control participants.

Official Title
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Time Restricted Eating for Weight Management

Conditions
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Obesity

Intervention / Treatment
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* Other: 8-hour Time restricted eating
* Other: Calorie restriction


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Age between 18 to 65 years old BMI between 30 and 50 kg/m2 Sedentary or lightly active (<60 minutes/week of light activity for the 3 months prior to the study) Exclusion criteria: • Type 1 DM or Type 2 DM History of eating disorders (anorexia, bulimia, or binge eating disorder) Are not weight stable for 3 months prior to the beginning of study (weight gain or loss > 4 kg) Are not able to keep a food diary or activity log for 7 consecutive days during screening Are taking drugs that influence study outcomes (weight loss, glucose-lowering medications) Are perimenopausal or have an irregular menstrual cycle (menses that does not appear every 27-32 days) Are eating within less than a 10-hour window at baseline Are pregnant, or trying to become pregnant Are night shift workers Are smokers

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 8-hour Time restricted eating<br>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<br>* Ad libitum food intake from 12-8 pm every day Fasting from 8-12 pm every day (16-h fast)<br>|
| Experimental: Calorie restriction<br>25% energy restriction every day | Other: Calorie restriction<br>* 25% energy restriction every day<br>|
| No Intervention: Control<br>Usual diet, Ad libitum intake, eating within >10 hours per day | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight | Measured by an electronic scale | Measured at month 0, 6 and 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fat mass, lean mass, visceral fat mass | Measured by DXA | Measured at month 0, 6 and 12 | 
| Change in bone mineral density | Measured by DXA | Measured at month 0, 6 and 12 | 
| Change in waist circumference | Measured by a measuring tape | Measured at month 0, 6 and 12 | 
| Change in Insulin resistance | Measured by HOMA-IR | Measured at month 0, 6 and 12 | 
| Change in Insulin sensitivity | Measured by QUICKI | Measured at month 0, 6 and 12 | 
| Change in Fasting glucose | Measured by a commercial lab (Medstar, IL) | Measured at month 0, 6 and 12 | 
| Change in HbA1c | Measured by a commercial lab (Medstar, IL) | Measured at month 0, 6 and 12 | 
| Change in Fasting insulin | Measured by a commercial lab (Medstar, IL) | Measured at month 0, 6 and 12 | 
| Change in Blood pressure | Measured by a blood pressure cuff | Measured at month 0, 6 and 12 | 
| Change in Heart rate | Measured by a blood pressure cuff | Measured at month 0, 6 and 12 | 
| Change in Plasma lipids (LDL cholesterol, HDL cholesterol, triglycerides) | Measured by a commercial lab (Medstar, IL) | Measured at month 0, 6 and 12 | 
| Change in inflammatory markers (TNF-apha, IL-6, IL-10, IL-B, hs-CRP) | Measured by ELISA | Measured at month 0, 6 and 12 | 
| Change in oxidative stress | Measured by ELISA | Measured at month 0, 6 and 12 | 
| Change in energy and nutrient intake | Measured by 7-day food record | Measured at month 0, 6 and 12 | 
| Change in physical activity (steps/d) | Measured by pedometer | Measured at month 0, 6 and 12 | 
| Change in the daily eating window | Measured by questionnaire (assesses the time the participant started and stopped eating each day) | Measured at month 0, 6 and 12 | 
| Change in sleep quality | Measured by Pittsburgh Sleep Quality Index (PSQI), total score of 0-21. A PSQI total score greater than 5 indicates poor sleep quality. | Measured at month 0, 6 and 12 | 
| Change in insomnia severity | 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). | Measured at month 0, 6 and 12 | 
| Change in risk of sleep apnea | Measured by Berlin Questionnaire, measures the presence or absence of sleep apnea | Measured at month 0, 6 and 12 | 
| Change in mood | Measured by Beck Depression Inventory II (BDI-II) 25: total score 0-100. Higher scores mean worse outcome. Also measured by the Profile of Mood States (POMS)total score 0-100. Higher scores mean worse outcome. | Measured at month 0, 6 and 12 | 
| Change in quality of life | Measured by the Short Form Survey (SF-36): total score 0-100. Higher scores mean worse outcome. | Measured at month 0, 6 and 12 | 
| Adverse events | Measured by questionnaire | Measured at month 0, 6 and 12 | 
| Change in appetite | Measured by Visual analog scale (VAS). Scored from 0-100. Higher score means higher appetite. | Measured at month 0, 6 and 12 | 
| Change in eating disorder symptoms | Measured by Multifactorial Assessment of Eating Disorders Symptoms (MAEDS), total score of 0-100, Higher scores mean worse outcome. | Measured at month 0, 6 and 12 |