Time-restricted eating to improve cardiometabolic health: The New York Time-Restricted EATing randomized clinical trial - Protocol overview

Abstract

Re-aligning eating patterns with biological rhythm can reduce the burden of metabolic syndrome in older adults with overweight or obesity. Time-restricted eating (TRE) has been shown to result in weight loss and improved cardiometabolic health while being less challenging than counting calories. The New York Time-Restricted EATing study (NY-TREAT) is a two-arm, randomized clinical trial (RCT) that aims to examine the efficacy and sustainability of TRE (eating window ≤10 h/day) vs. a habitual prolonged eating window (HABIT, ≥14 h/day) in metabolically unhealthy midlife adults (50-75 years) with overweight or obesity and prediabetes or type 2 diabetes (T2D). Our primary hypothesis is that the TRE will result in greater weight loss compared to HABIT at 3 months. The efficacy of the TRE intervention on body weight, fat mass, energy expenditure, and glucose is tested at 3 months, and the sustainability of its effect is measured at 12 months, with ambulatory assessments of sleep and physical activity (ActiGraph), eating pattern (smartphone application), and interstitial glucose (continuous glucose monitoring). The RCT also includes state-of-the-art measurements of body fat (quantitative magnetic resonance), total energy expenditure (doubly-labelled water), insulin secretion, insulin resistance, and glucose tolerance. Adherence to self-monitoring and reduced eating window are monitored remotely in real-time. This RCT will provide further insight into the effects of TRE on cardiometabolic health in individuals with high metabolic risk. Sixty-two participants will be enrolled, and with estimated 30% attrition, 42 participants will return at 12 months. This protocol describes the design, interventions, methods, and expected outcomes. Clinical trial registration:NCT04465721 IRB: AAAS7791.

Keywords: Continuous glucose monitoring system; Diabetes; Doubly labelled water; Glucose; Meal timing; Prediabetes; Time-restricted eating.

Fig. 1.

Working model. The effect of TRE on fat mass and glucose will be mediated by decreased energy intake - assessed by doubly labelled water.

Fig. 2.

Study timeline. After screening, participants are enrolled for a total duration of 12 months. They complete a baseline period of two weeks before randomization. Upon randomization, subjects enter the 12-month intervention, with a repeat 2-week assessment at the end of 3 months, and at 12 months. DLW = Doubly Labelled Water. OGTT = Oral Glucose Tolerance Test. QMR = Quantitative Magnetic Resonance.

Fig. 3.

Timetable of study procedures during the 2-week baseline assessment. * = All assessments are repeated during the last 2 weeks of 3 months, except randomization. † = Assessments completed at 12 months. QMR = Quantitative Magnetic Resonance, DLW = Doubly Labelled Water, CGM = Continuous Glucose Monitoring, mCC = myCircadianClock, ASA24 = Automated Self-Administered 24-h, OGTT = Oral Glucose Tolerance Test, TRE = Time-Restricted Eating.