Design and Implementation of a Time-Restricted Eating Intervention in a Randomized, Controlled Eating Study.

The efficacy of time-restricted eating for weight loss has not been established, as prior studies were limited by a lack of controlled isocaloric designs. This study describes the design and implementation of interventions in a controlled eating study evaluating time-restricted eating. We designed a randomized, controlled, parallel-arm eating study comparing time-restricted eating (TRE) to a usual eating pattern (UEP) for the primary outcome of weight change. Participants were aged 21-69 years with prediabetes and obesity. TRE consumed 80% of calories by 1300 h (military time), and UEP consumed ≥ 50% of calories after 1700 h (military time). Both arms consumed identical macro- and micro-nutrients based on a healthy, palatable diet. We calculated individual calorie requirements, which were maintained throughout the intervention. The desired distribution of calories across eating windows in both arms was achieved, as were the weekly averages for macronutrients and micronutrients. We actively monitored participants and adapted diets to facilitate adherence. We provide the first report, to our knowledge, on the design and implementation of eating study interventions that isolated the effect of meal timing on weight while maintaining constant caloric intake and identical diets during the study period.