Intermittent Fasting Versus Carbohydrate Drinks Before Surgery (NCT05760339) | Clinical Trial Compass
RecruitingNot Applicable
Intermittent Fasting Versus Carbohydrate Drinks Before Surgery
Netherlands75 participantsStarted 2023-03-20
Plain-language summary
The purpose of this study is to investigate whether time-restricted feeding, a form of intermittent fasting, before surgery improves insulin resistance around the time of surgery, compared to carbohydrate drinks and standard fasting before surgery.
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:
* Undergoing elective orthopaedic surgery;
* Intermediate, major or complex surgery according to the Surgical Outcome Risk Tool (SORT; http://www.sortsurgery.com/) severity of surgery classification;
* Scheduled for surgery at least 17 days from the date of screening;
* Motivated to follow a time restricted feeding regimen.
* Willing and able to provide written informed consent.
Exclusion Criteria:
* History of diabetes mellitus;
* History of feeding or eating disorders;
* History of delayed gastric emptying or gastro-oesophageal reflux
* Active malignancy
* Patients classified as ASA IV by the attending anaesthetist;
* BMI \< 18.5 or ≥ 35;
* Outpatient or day case surgery;
* Palliative surgery;
* Participation in another clinical trial that is interfering with the procedures or outcomes of the PRINCESS trial;
* Patients unable to fully comply to study needs (e.g. legally incapable patients or patients unable to communicate in Dutch).
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
Insulin resistance on postoperative day 1
Timeframe: Postoperative day 1
Trial details
NCT IDNCT05760339
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)