Comparing intermittent fasting and carbohydrate drinks before surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of time-restricted feeding (intermittent fasting) versus carbohydrate loading on insulin resistance in patients undergoing orthopedic surgery. Participants in the time-restricted feeding group will follow an 8-hour eating window and a 16-hour fasting period for two weeks prior to surgery, while the carbohydrate loading group will consume a maltodextrin beverage before surgery. The goal is to determine which approach better improves metabolic outcomes around the time of surgery.

Why it matters

Who can join: the full rules

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).

Where it's running

• Amsterdam UMC location AMC
  Amsterdam, North Holland, Netherlands Recruiting

Study contacts

• Principal investigator: Jeroen Hermanides, MSc — Amsterdam UMC, location AMC
• Study coordinator: A. Stobbe, MSc
• Email: a.y.stobbe@amsterdamumc.nl
• Phone: +31205669111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.