Optimization of Diet Before Surgery (OptiSurg)

Vaud University Hospital Center

Status

Unknown

Conditions

Surgery

Time Restricted Feeding

Treatments

Behavioral: Standard dietary advices

Behavioral: Time restricted feeding

Study type

Interventional

Funder types

Other

Identifiers

NCT04627688

2019-02483

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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