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

Aug 7, 2022Contemporary clinical trials

Time-restricted eating to improve heart and metabolic health: Overview of the New York clinical trial plan

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Abstract

Sixty-two participants will be enrolled in a randomized clinical trial comparing time-restricted eating (TRE) with habitual prolonged eating.

Time-restricted eating involves an eating window of 10 hours or less per day.
The study targets metabolically unhealthy midlife adults aged 50-75 with overweight or obesity and prediabetes or type 2 diabetes.
The primary hypothesis is that TRE will lead to greater weight loss than the habitual prolonged eating group at 3 months.
Various health metrics, including body weight, fat mass, and glucose levels, will be assessed at 3 months.
The sustainability of TRE's effects will be evaluated at 12 months with ongoing monitoring of lifestyle factors.

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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.

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

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