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Compares treatment options for Perioperative Care
Official title Intermittent Fasting Versus Carbohydrate Drinks Before Surgery
ClinicalTrials.gov ID: NCT05760339
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Undergoing elective orthopaedic surgery;
- Intermediate, major or complex surgery according to the Surgical Outcome Risk Tool (SORT; http://www.sortsurgery.com/) severity of surgery...
- 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.
You likely can't join if
- 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;
See the full eligibility 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.
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Amsterdam, North Holland, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amsterdam, North Holland, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.