NCT05760339 Intermittent Fasting Versus Carbohydrate Drinks Before Surgery
| NCT ID | NCT05760339 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
| Condition | Perioperative Care |
| Study Type | INTERVENTIONAL |
| Enrollment | 75 participants |
| Start Date | 2023-03-20 |
| Primary Completion | 2025-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 75 participants in total. It began in 2023-03-20 with a primary completion date of 2025-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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).
Contact & Investigator
Jeroen Hermanides, MSc
PRINCIPAL INVESTIGATOR
Amsterdam UMC, location AMC
Frequently Asked Questions
Who can join the NCT05760339 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Perioperative Care. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05760339 currently recruiting?
Yes, NCT05760339 is actively recruiting participants. Contact the research team at a.y.stobbe@amsterdamumc.nl for enrollment information.
Where is the NCT05760339 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands.
Who is sponsoring the NCT05760339 clinical trial?
NCT05760339 is sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). The principal investigator is Jeroen Hermanides, MSc at Amsterdam UMC, location AMC. The trial plans to enroll 75 participants.