Design of the OptiSurg trial: Multicenter open-label randomized controlled trial of time restricted feeding (TRF) vs regular dietary advices in patient undergoing femoral endarterectomy

Abstract

Abstract Objective Vascular patients suffer some of the highest complications rates. Surprisingly, there is no uniformly accepted medical therapy to reduce complications in these patients. Time restricted feeding (TRF) is an approach that emphasizes energy intake limited to certain windows of time within the 24-hour cycle, without restrictions on any calories or macronutrients. In healthy young human, TRF improves cardio-metabolic fitness. However, there is a lack of research on TRF in patient undergoing surgery, and suffering from cardiovascular diseases. This study aims to investigate the feasibility and efficacy of a pre-operative 2-week, 10-hour TRF in patient undergoing vascular surgery. Methods The OptiSurg Study is a randomized open-label clinical trial, that plan to enroll 40 patients, undergoing elective femoral endarterectomy. Only Fontaine stage II peripheral artery disease, and a BMI ≥ 20 kg/m2 are included. Patients are randomized with a 1:1 ratio to either the control or intervention group. The control group receives diet nutritional counselling (standard of care, SOC). The intervention group receives the same SOC and a self-selected 10-hour TRE window. After the surgery, patients will be on SOC only, and followed every 3 months up to 1 year. Primary endpoint is a composite of death, myocardial infarction, stroke, and surgical re-intervention at 1 month post-operative. Blood glucose, body weight, body composition, biomarkers (neuroendocrine, inflammatory and metabolic), sleep and quality of life will also be examined. Temporal calorie intake is monitored with the smartphone application myCircadianClock preoperatively. VascuQoL-6 is used to monitor quality of life. Results 9 participants were enrolled since the start of the recruitment in February 2021, 4 were randomized in the 8 hours TRF intervention, and 5 to SOC. They all completed the study: 7 men and 2 women, age 73, 53–87 (median, min-max) years. Using the myCircadianClock app, adherence to the TRF was >90% (Figure 1). Conclusion Our preliminary experience seems to demonstrate that a 2-week TRF regimen before vascular surgery is feasible. The complete results will be disseminated through future peer-reviewed manuscripts, reports and presentations.