Time Restricted Eating for Weight Management

Obesity Clinical Trial

Official title:

Time Restricted Eating for Weight Management

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04692532
• Other study ID #: 2020-1512
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: July 1, 2026

Study information

• Verified date: January 2024
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 90
• Est. completion date: July 1, 2026
• Est. primary completion date: July 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

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)
• Calorie restriction
25% energy restriction every day

Locations

Country	Name	City	State
United States	University of Illinois Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body weight	Measured by an electronic scale	Measured at month 0, 6 and 12
Secondary	Change in fat mass, lean mass, visceral fat mass	Measured by DXA	Measured at month 0, 6 and 12
Secondary	Change in bone mineral density	Measured by DXA	Measured at month 0, 6 and 12
Secondary	Change in waist circumference	Measured by a measuring tape	Measured at month 0, 6 and 12
Secondary	Change in Insulin resistance	Measured by HOMA-IR	Measured at month 0, 6 and 12
Secondary	Change in Insulin sensitivity	Measured by QUICKI	Measured at month 0, 6 and 12
Secondary	Change in Fasting glucose	Measured by a commercial lab (Medstar, IL)	Measured at month 0, 6 and 12
Secondary	Change in HbA1c	Measured by a commercial lab (Medstar, IL)	Measured at month 0, 6 and 12
Secondary	Change in Fasting insulin	Measured by a commercial lab (Medstar, IL)	Measured at month 0, 6 and 12
Secondary	Change in Blood pressure	Measured by a blood pressure cuff	Measured at month 0, 6 and 12
Secondary	Change in Heart rate	Measured by a blood pressure cuff	Measured at month 0, 6 and 12
Secondary	Change in Plasma lipids (LDL cholesterol, HDL cholesterol, triglycerides)	Measured by a commercial lab (Medstar, IL)	Measured at month 0, 6 and 12
Secondary	Change in inflammatory markers (TNF-apha, IL-6, IL-10, IL-B, hs-CRP)	Measured by ELISA	Measured at month 0, 6 and 12
Secondary	Change in oxidative stress	Measured by ELISA	Measured at month 0, 6 and 12
Secondary	Change in estradiol levels (ng/ml)	Measured by ELISA	Measured at month 0, 6 and 12
Secondary	Change in testosterone levels (ng/ml)	Measured by ELISA	Measured at month 0, 6 and 12
Secondary	Change in dehydroepiandrosterone (DHEA) levels (ng/ml)	Measured by ELISA	Measured at month 0, 6 and 12
Secondary	Change in sex hormone binding globulin (SHBG) levels (ng/ml)	Measured by ELISA	Measured at month 0, 6 and 12
Secondary	Change in progesterone levels (ng/ml)	Measured by ELISA	Measured at month 0, 6 and 12
Secondary	Change in energy and nutrient intake	Measured by 7-day food record	Measured at month 0, 6 and 12
Secondary	Change in physical activity (steps/d)	Measured by pedometer	Measured at month 0, 6 and 12
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Adverse events	Measured by questionnaire	Measured at month 0, 6 and 12
Secondary	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
Secondary	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