The overarching goal of this project is to assess whether a controlled short-term Time restricted feeding (TRF) intervention leads to metabolic benefits, improves recovery after vascular surgery and that TRF is safe. Participants suffering from intermittent claudication (Fontaine stage II peripheral artery disease, PAD) will be randomly assigned to a 2-week TRF or active control dietary advices before open surgical revascularization. Prior to the surgery, the investigators will assess the eating patterns of participants with an innovative smartphone application ('app') which is less intrusive and more reliable than food diaries/questionnaires to assess eating behavior and patterns. In the second part of the study, the investigators will investigate whether a short term TRF intervention improves surgical recovery, in the short-term (1 month, primary endpoint) and long-term (optional, up to 1 year), as part of the routine clinical follow-up. This proposal builds on established expertise in the biology of dietary intervention, surgery, and study of eating patterns in human.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
40
Participants will be advised to eat only during a selected window of 8 hours, and no later than 4pm, with no advice on nutrition quality, quantity or caloric intake. The intervention will include no medication, no medical device, and will last for 2 weeks prior to surgery.
Participants will be given standard dietary advices, as recommended by the international nutrition guidelines, and thus are not different from common clinical practice.
Brigham and Women's Hospital
Boston, Massachusetts, United States
NOT_YET_RECRUITINGCentre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Canton of Vaud, Switzerland
RECRUITINGNumber of participants with: Death, Myocardial infarction, Stroke, Surgical re-intervention.
Safety of TRF before vascular surgery
Time frame: 1 month
Length of Stay [days]
Time frame: 1 month
Change in systolic and diastolic blood pressure [mmHg]
Time frame: 1 month
Change in ankle and toe brachial index [0.2-1.4]
Improvement in limb perfusion measured as an increase in the reported index
Time frame: 1 month
Change in weight [gram]
Time frame: 1 month
Change in BMI [kg/m^2]
Time frame: 1 month
Change in total cholesterol levels [mg/dl]
Time frame: 1 month
Change in LDL cholesterol levels [mg/dl]
Time frame: 1 month
Change in HDL cholesterol levels [mg/dl]
Time frame: 1 month
Change in triglyceride levels [mg/dl]
Time frame: 1 month
Change in glycemia [mmol/L]
Time frame: 1 month
Change in insulin levels [pmol/L]
Time frame: 1 month
Change in HbA1c levels [%]
Time frame: 1 month
Adherence to TRF intervention
Adherence will be determined using the smartphone app, by the number of days in which a participant will be adherent to logging and all caloric food items were contained within a 15-min buffer on each side of the selected eating window.
Time frame: 1 month
Time from randomization to the first occurrence of any of the following major thrombotic vascular events: MI (Myocardial infarction), ischemic stroke, CV (Cardiovascular) death, ALI (Acute limb ischemia), and major amputation or death (any cause).
Time frame: 1 year
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