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Recruiting NCT05760339

Intermittent Fasting Versus Carbohydrate Drinks Before Surgery

No phase Interventional Perioperative Care Intermittent Fasting Carbohydrate Loading Preoperative Fasting

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Time-restricted feeding, Carbohydrate loading.
Who it may be relevant to
Registry conditions: Perioperative Care, Intermittent Fasting, Carbohydrate Loading, Preoperative Fasting. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Preoperative Intermittent Fasting Versus Carbohydrate Loading to Reduce Insulin Resistance: a Randomised Controlled Trial

Overview

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.

Detailed description

Patients in the Time-Restricted Feeding (TRF) group will follow a daily TRF regimen consisting of an 8h ad libitum eating period and a 16h water fasting period during the last two weeks before surgery, followed by routine preoperative fasting before surgery.

Patients in the CarboHydrate Loading (CHL) group will follow their usual diet in the pre-surgical weeks and will receive a maltodextrin beverage on the evening before surgery, as well as two hours before induction of anaesthesia.

Interventions

  • Behavioral Time-restricted feeding
    Subjects in the will be instructed to follow a TRF regimen consisting of a daily 8h ad libitum eating period and 16h water fasting period during the last 2 weeks before surgery. Participants will be encouraged to begin their eating period at 08:00h and end it at 16:00h, since the metabolic benefits of TRF appear to be considerably more pronounced when the eating period starts early in the day.
  • Dietary supplement Carbohydrate loading
    Subjects will continue their usual diet and will receive two quantities of a clear beverage containing 12.5 g/100 mL maltodextrin (50 kCal/100 mL, pH 5.0); 800 mL at 22.00h on the evening before surgery and 400 mL two hours before anaesthesia induction.

Primary outcome measures

  • Insulin resistance on postoperative day 1 [Time frame: Postoperative day 1]
Secondary outcome measures (3)
  • Difference in HOMA2-IR [Time frame: From baseline to day of surgery, from baseline to postoperative day 1 and from day of surgery to postoperative day 1.]
  • Beta-cell function [Time frame: The day of surgery and the first postoperative day]
  • Patient wellbeing [Time frame: During the two weeks preoperatively, until one day postoperatively]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Netherlands · 1 center
  • Amsterdam UMC location AMC — Amsterdam

Publications

  • Stobbe AY, de Klerk ES, van Wilpe R, Kievit AJ, Choi KF, Preckel B, Hollmann MW, Hermanides J, van Stijn MFM, Hulst AH. Study protocol of the PRINCESS trial-PReoperative INtermittent fasting versus CarbohydratE loading to reduce inSulin resiStance versus standard of care in orthopaedic patients: a randomised controlled trial. BMJ Open. 2025 Jan 21;15(1):e087260. doi: 10.1136/bmjopen-2024-087260. PMID 39842917

Identifiers

NCT: NCT05760339 · PRINCESS trial

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗