Optimization of Diet Before Surgery (OptiSurg) (NCT04627688) | Clinical Trial Compass
UnknownNot Applicable
Optimization of Diet Before Surgery (OptiSurg)
United States, Switzerland40 participantsStarted 2021-01-25
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with: Death, Myocardial infarction, Stroke, Surgical re-intervention.