NCT04627688

Optimization of Diet Before Surgery (OptiSurg)

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Centre Hospitalier Universitaire Vaudois · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Surgery
• Time Restricted Feeding

Interventions

Type	Name	Description
BEHAVIORAL	Time restricted feeding	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.
BEHAVIORAL	Standard dietary advices	Participants will be given standard dietary advices, as recommended by the international nutrition guidelines, and thus are not different from common clinical practice.

Timeline

• Start date: 2021-01-25
• Primary completion: 2022-11-01
• Completion: 2023-07-01
• First posted: 2020-11-13
• Last updated: 2021-08-03

Locations

2 sites across 2 countries: United States, Switzerland