Clinical trial NCT04627688: Optimization of Diet Before Surgery (OptiSurg)
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Surgery
Time Restricted Feeding
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2020-11-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with: Death, Myocardial infarction, Stroke, Surgical re-intervention.
timeFrame: 1 month
Secondary outcomes:
measure: Length of Stay [days]
timeFrame: 1 month
measure: Change in systolic and diastolic blood pressure [mmHg]
timeFrame: 1 month
measure: Change in ankle and toe brachial index [0.2-1.4]
timeFrame: 1 month
measure: Change in weight [gram]
timeFrame: 1 month
measure: Change in BMI [kg/m^2]
timeFrame: 1 month
measure: Change in total cholesterol levels [mg/dl]
timeFrame: 1 month
measure: Change in LDL cholesterol levels [mg/dl]
timeFrame: 1 month
measure: Change in HDL cholesterol levels [mg/dl]
timeFrame: 1 month
measure: Change in triglyceride levels [mg/dl]
timeFrame: 1 month
measure: Change in glycemia [mmol/L]
timeFrame: 1 month
measure: Change in insulin levels [pmol/L]
timeFrame: 1 month
measure: Change in HbA1c levels [%]
timeFrame: 1 month
measure: Adherence to TRF intervention
timeFrame: 1 month
measure: 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).
timeFrame: 1 year
Other outcomes:
measure: Change in interleukin-6,-1, -10 levels [pg/ml]
timeFrame: 1, 2 days ans 1 month
measure: Change in tumor necrosis factor alpha levels [pg/mL]
timeFrame: 1, 2 days ans 1 month
measure: Change in transforming growth factor beta levels [ng/mL]
timeFrame: 1, 2 days ans 1 month
measure: Change in interferon gamma levels [pg/mL]
timeFrame: 1, 2 days ans 1 month
measure: Change in cortisol levels [nmol/L]
timeFrame: 1, 2 days ans 1 month
measure: Change in thyroid stimulating hormone levels [mIU/L]
timeFrame: 1, 2 days ans 1 month
measure: Change in triiodothyronine levels [nmol/L]
timeFrame: 1, 2 days ans 1 month
measure: Change in thyroxine levels [μg/d]
timeFrame: 1, 2 days ans 1 month
measure: Change in circulating hydrogen sulphide levels
timeFrame: 1, 2 days ans 1 month
measure: Change in circadian hormone secretion
timeFrame: 1, 2 days ans 1 month
measure: Change in gut microbiome
timeFrame: 1, 2 days ans 1 month
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois (CHUV)
state: Vaud
Study officials:
References: