Pilot Clinical Trial of Time-Restricted Eating in Patients with Metabolic Syndrome

Abstract

Metabolic syndrome (MetS) and erratic eating patterns are associated with circadian rhythm disruption which contributes to an increased cardiometabolic risks. Restricting eating period (time-restricted eating, TRE) can restore robust circadian rhythms and improve cardiometabolic health. We describe a protocol of the Time-Restricted Eating on Metabolic and Neuroendocrine homeostasis, Inflammation, and Oxidative Stress (TREMNIOS) pilot clinical trial in Polish adult patients with MetS and eating period of ≥14 h/day. The study aims to test the feasibility of TRE intervention and methodology for evaluating its efficacy for improving metabolic, neuroendocrine, inflammatory, oxidative stress and cardiac biomarkers, and daily rhythms of behavior for such population. Participants will apply 10-h TRE over a 12-week monitored intervention followed by a 12-week self-directed intervention. Changes in eating window, body weight and composition, biomarkers, and rhythms of behavior will be evaluated. Dietary intake, sleep, activity and wellbeing will be monitored with the myCircadianClock application and questionnaires. Adherence to TRE defined as the proportion of days recorded with app during the monitored intervention in which participants satisfied 10-h TRE is the primary outcome. TREMNIOS will also provide an exploratory framework to depict post-TRE changes in cardiometabolic outcomes and behavior rhythms. This protocol extends previous TRE-related protocols by targeting European population with diagnosed MetS and including long-term intervention, validated tools for monitoring dietary intake and adherence, and comprehensive range of biomarkers. TREMNIOS trial will lay the groundwork for a large-scale randomized controlled trial to determine TRE efficacy for improving cardiometabolic health in MetS population.

Nutrients and the Circadian Clock: A Partnership Controlling Adipose Tissue Function and Health

“…Time-of-day nutrient digestion has also proved to be important for rhythmicity in metabolic gene expression in other tissues. Time restricted feeding (TRF) under both chow and high fat diet conditions can boost the amplitude of rhythms in hepatic gene expression and in serum metabolite abundance [ 55 , 92 , 93 , 94 , 95 , 96 ], while restricting feeding to the rest phase instead of the active phase puts time-keeping between peripheral clocks and the central pacemaker out of sync [ 97 ]. Restricted feeding to the rest phase also destroys the temporal pattern of circulating bile acids in the serum.…”

Effectiveness of Intensive Cardiac Rehabilitation in High-Risk Patients with Cardiovascular Disease in Real-World Practice

“…Large-scale, prospective, randomized controlled trials on various ICR programs with long follow-up, also in selective populations such as women, as well as extensions of study protocols by including a comprehensive range of biomarkers (e.g., inflammatory, neuroendocrine, and oxidative stress), are needed [4,5,41,[57][58][59][60]. In addition, new CR modalities such as various types of exercise training and diets, time-restricted eating, telerehabilitation, and home-based CR require further clinical research [21,22,41,[61][62][63]. Future studies on lifestyle modification plans and updated guidelines and health policies are needed to alleviate long-term cardiometabolic and overall health risks in CVD patients.…”

Adipocyte Phenotype Flexibility and Lipid Dysregulation

“…Disrupting ad libitum access to a high-fat diet prevents mice from developing obesity, hyperinsulinemia, hepatic steatosis, and inflammation, despite eating equivalent calories [ 138 , 139 ]. Preliminary reports on the effectiveness of intermittent fasting as a treatment for patients with metabolic syndrome are promising [ 140 ], and clinical work to corroborate these preliminary data is underway [ 141 ].…”