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

“Intermittent fasting (IF) has gained attention as a simple weight loss method. Intermittent fasting refers to eating windows separated by defined periods of fasting (>12 hours and up to 48 hours, or more). Most of the reported benefits of IF are either untested or undertested in humans. Time-restricted eating (TRE) is a specific IF protocol involving consistent fasting and eating periods within a 24-hour cycle. [..] We conducted a randomized clinical trial (RCT) designed to determine the effect of TRE on weight and comprehensive metabolic outcomes in overweight and obese patients. We hypothesized that 8-hour TRE prescribed to individuals with overweight and obesity would lead to weight loss and improvements in metabolic markers compared with individuals following a standard 3-meals-per-day diet (consistent meal timing [CMT]).

[..] Participants received study surveys through the study app. Participants were given a bluetooth weight scale to use daily, which was connected through the study app. Participants were randomized to 1 of 2 interventions. The study intervention only included recommendations to the timing of food intake (no recommendation for calorie and macronutrient intake or physical activity), and participants received daily reminders about their eating windows through the app. The CMT group was instructed to eat 3 structured meals per day. Snacking between meals was permitted. The TRE group was instructed to eat ad libitum from 12:00 pm until 8:00 pm and completely abstain from caloric intake from 8:00 pm until 12:00 pm the following day (16 hours fast:8 hours eat). Only noncaloric beverages were permitted outside of the eating widow. Participants provided consent through the app, and received a $50 Visa gift card for participating in the study.

[..] Of the 141 participants who were randomized to 1 of the 2 interventions, 105 (74.5%) completed the entire 12-week intervention. [..] Self-reported adherence to the diets was 1002 of 1088 (92.1%) in the CMT group (did not miss any meals) and 1128 of 1351 (83.50%) in the TRE group (ate only within the 8-hour window).

[..] There was a significant decrease in weight in the TRE group (−0.94 kg; 95% CI, −1.68 kg to −0.20 kg) and a nonsignificant decrease in weight in the CMT group (−0.68 kg; 95% CI, −1.41 kg to 0.05 kg). Importantly, there was no significant difference in weight change between groups (−0.26 kg; 95% CI, −1.30 kg to 0.78 kg).

[..] As measured by dual-energy x-ray absorptiometry (DXA), there was no significant change in whole body fat mass (FM) in the TRE (−0.51 kg; 95% CI, −1.17 kg to 0.15 kg) or the CMT groups (−0.03 kg; 95% CI, −0.66 kg to 0.60 kg). [..] There was a significant decrease in lean mass (calculated as fat-free mass minus bone mineral content) in the TRE (−1.10 kg; 95% CI, −1.73 kg to −0.48 kg) but not in the CMT group (−0.35 kg; 95% CI, −0.95 kg to 0.25 kg). There was no significant difference in lean mass between groups (−0.75 kg; 99.7% CI, −1.96 kg to 0.45 kg).

[..] There were no significant within-group or between-group differences in fasting glucose, fasting insulin, HOMA-IR, HbA1C, triglycerides, total cholesterol, LDL, or HDL levels. [..] There was no significant difference in systolic blood pressure in the TRE group (−1.69 mm Hg; 95% CI, −5.54 mm Hg to 2.15 mm Hg), but there was a significant decrease in the CMT group (−3.86 mm Hg; 95% CI, −7.58 mm Hg to 0.14 mm Hg). There was no significant between-group difference in systolic blood pressure (2.17 mm Hg; 95% CI, −3.18 mm Hg to 7.52 mm Hg).

[..] Together, the results of this study (1) do not support the efficacy of TRE for weight loss, (2) highlight the importance of control interventions, and (3) offer caution about the potential effects of TRE on ALM. Future studies should be aimed at understanding the effects of early vs late TRE and protein intake or timing as a means to offset the loss in ALM [appendicular lean mass].”

Full article, Lowe DA, Wu N, Rohdin-Bibby L et al. JAMA Internal Medicine 2020.9.28