Impact of Time-Restricted Feeding (TRF) on Glucose Homeostasis and Mitochondrial Function in Patients with Metabolic Syndrome

University Of California, San Diego, La Jolla CA

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Abstract

Project Abstract Metabolic Syndrome (MetS) is more prevalent than Type 2 Diabetes, is increasing worldwide, and is associated with an increased risk of cardiovascular disease. In the US, MetS affects 93 million people and studies have shown healthcare costs to be as much as 20% higher in MetS patients. Given the higher prevalence of MetS, the need for concomitant management of multiple conditions, and the alarmingly low adherence rates to current medications and interventions for MetS, it is urgent that a more effective long-term solution is found that can be delivered easily in everyday clinical practice. Time-restricted eating (TRE) is a low cost, low management solution that has proven effective in numerous clinical trials. TRE involves an extended fasting period overnight of about 14 hours with a 10-hour eating window. Previous studies have shown that TRE, even without other dietary changes, can lead to weight loss, improve glucose regulation, and decrease LDL cholesterol and blood pressure. However, there are few long-term studies of TRE, particularly in MetS patients who are receiving concurrent standard of care medication and lifestyle management. We hypothesize that TRE can provide additional benefits to MetS patients especially over the long term because adherence rates are higher (80%) to the simpler TRE prescription (14 hour fast/10-hour eating). We will conduct a 2-arm randomized controlled trial in patients (18-70 years) diagnosed with MetS and receiving standard of care (n=140). Participants will be randomized to continue lifestyle and medication management or to receive the additional TRE 10-hour prescription over a 12-month period supported by a well-tested mHealth app (developed by the research team with over 110K users) and remote support from study staff. We will evaluate the impact of TRE on key cardiometabolic risk factors (HbA1c and LDL) over time. We will characterize the underlying mechanisms of changes in glycemic control through assessments of glycemic variability on continuous glucose monitoring and insulin sensitivity via oral glucose tolerance tests. We will assess the safety of TRE on body composition and track the relationship between TRE adherence and outcomes. We will also explore the impact of TRE on plasma metabolites associated with increased risk of diabetes and cardiovascular disease. TRE has the potential to greatly improve MetS treatment by providing a low-cost intervention expected to have high-adherence and significantly improve multiple clinical outcomes. Our central hypothesis is that TRE is a sustainable long-term lifestyle strategy that will improve cardiometabolic health.