Optimization of Diet Before Surgery (OptiSurg): Effects of Time Restricted Feeding (TRF) Before Vascular Surgery - An Open-label Randomized Controlled Trial of TRF vs Regular Dietary Advices
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 40
- Locations
- 4
- Primary Endpoint
- Number of participants with: Death, Myocardial infarction, Stroke, Surgical re-intervention.
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 18 years
- •Fontaine stage II peripheral artery disease planned for open femoral endarterectomy
- •Body mass index ≥ 20 kg/m2
- •Smartphone compatible with the app (iOS or Android systems)
- •Hypertensive (or on 1 or more blood pressure lowering medication)
- •Hypercholesterolemia (or on 1 or more lipid lowering medication)
Exclusion Criteria
- •Diabetes on insulin therapy or sulfonylureas
- •Fontaine stage III and IV peripheral artery disease
- •Prior revascularization on the index leg within 14 days of the qualifying revascularization.
- •Major surgery in the past 3 months
- •Myocardial infarction or revascularization (PTA, stent, CABG) in the past 3 months
- •Major illness / fever over the previous month, active cancer
- •On a diet / weight management or prior bariatric surgery
- •Major mental illness, unable to give consent, inability to follow study procedures (language barrier, dementia)
- •Current shift work or travel abroad planned in the next month
- •Major sleep disorder
- •Enrolled in another interventional clinical trial
- •Ongoing pregnancy
Outcomes
Primary Outcomes
Number of participants with: Death, Myocardial infarction, Stroke, Surgical re-intervention.
Time Frame: 1 month
Safety of TRF before vascular surgery
Secondary Outcomes
- Length of Stay [days](1 month)
- Change in BMI [kg/m^2](1 month)
- Change in total cholesterol levels [mg/dl](1 month)
- Change in HDL cholesterol levels [mg/dl](1 month)
- Change in triglyceride levels [mg/dl](1 month)
- Change in insulin levels [pmol/L](1 month)
- Change in glycemia [mmol/L](1 month)
- Change in HbA1c levels [%](1 month)
- Change in weight [gram](1 month)
- Change in LDL cholesterol levels [mg/dl](1 month)
- Change in systolic and diastolic blood pressure [mmHg](1 month)
- Change in ankle and toe brachial index [0.2-1.4](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).(1 year)
- Adherence to TRF intervention(1 month)
Investigators
Alban Longchamp
Principal Investigator
Centre Hospitalier Universitaire Vaudois