Effects of Time-Restricted Eating on Weight Loss and Other Metabolic Parameters in Women and Men With Overweight and Obesity The TREAT Randomized Clinical Trial

IMPORTANCE The efficacy and safety of time-restricted eating have not been explored in large randomized clinical trials. OBJECTIVE To determine the effect of 16:8-hour time-restricted eating on weight loss and metabolic risk markers. INTERVENTIONS Participants were randomized such that the consistent meal timing (CMT) group was instructed to eat 3 structured meals per day, and the time-restricted eating (TRE) group was instructed to eatad libitumfrom 12:00pmuntil 8:00pmand completely abstain from caloric intake from 8:00pmuntil 12:00pmthe following day. DESIGN, SETTING, AND PARTICIPANTS This 12-week randomized clinical trial including men and women aged 18 to 64 years with a body mass index (BMI, calculated as weight in kilograms divided by height in meters squared) of 27 to 43 was conducted on a custom mobile study application. Participants received a Bluetooth scale. Participants lived anywhere in the United States, with a subset of 50 participants living near San Francisco, California, who underwent in-person testing. MAIN OUTCOMES AND MEASURES The primary outcome was weight loss. Secondary outcomes from the in-person cohort included changes in weight, fat mass, lean mass, fasting insulin, fasting glucose, hemoglobin A(1c)levels, estimated energy intake, total energy expenditure, and resting energy expenditure. RESULTS Overall, 116 participants (mean [SD] age, 46.5 [10.5] years; 70 [60.3%] men) were included in the study. There was a significant decrease in weight in the TRE (-0.94 kg; 95% CI, -1.68 to -0.20;P = .01), but no significant change in the CMT group (-0.68 kg; 95% CI, -1.41 to 0.05,P = .07) or between groups (-0.26 kg; 95% CI, -1.30 to 0.78;P = .63). In the in-person cohort (n = 25 TRE, n = 25 CMT), there was a significant within-group decrease in weight in the TRE group (-1.70 kg; 95% CI, -2.56 to -0.83;P < .001). There was also a significant difference in appendicular lean mass index between groups (-0.16 kg/m(2); 95% CI, -0.27 to -0.05;P = .005). There were no significant changes in any of the other secondary outcomes within or between groups. There were no differences in estimated energy intake between groups. CONCLUSIONS AND RELEVANCE Time-restricted eating, in the absence of other interventions, is not more effective in weight loss than eating throughout the day.