Optimization of Diet Before Surgery (OptiSurg)
Status unconfirmed · Not applicable
Conditions studied: Surgery, Time Restricted Feeding
In brief
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.
Key facts
- Study ID
- NCT04627688
- Run by
- Centre Hospitalier Universitaire Vaudois
- People needed
- 40
- Starts
- 2021-01-25
- Expected to finish
- 2023-07-01
- Last updated by the study team
- 2021-08-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Centre Hospitalier Universitaire Vaudois (CHUV) — Lausanne, Canton of Vaud, Switzerland (enrolling)
- Brigham and Women's Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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