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NCT Number: NCT05760339

Intermittent Fasting Versus Carbohydrate Drinks Before Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amsterdam UMC location AMC

Amsterdam, North Holland, 1105AZ, Netherlands

Location status: Recruiting

Location contact

R. van Wilpe, MSc

CONTACT

[email protected]

+31205669111

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Time-restricted feeding

Behavioral

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.

Carbohydrate loading

Dietary Supplement

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 outcomes

  1. Insulin resistance on postoperative day 1

    Time frame: Postoperative day 1

    Insulin resistance according to the updated homeostasis model assessment of insulin resistance (HOMA2-IR)

Secondary outcomes

  1. 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.

    This is a calculated value between two timepoints, in contrary to the primary outcome that solely measures postoperative insulin resistance. The preoperative HOMA2-IR and the postoperative HOMA2-IR are used to determine whether there has been a change (increase or decrease) of the insulin resistance.

  2. Beta-cell function

    Time frame: The day of surgery and the first postoperative day

    The beta-cell function is based on the updated HOMA2 model. In addition to glucose and insulin, C-peptide measurements will be done to calculate HOMA2-B.

  3. Patient wellbeing

    Time frame: During the two weeks preoperatively, until one day postoperatively

    Patient wellbeing during and after the intervention and on the first postoperative day is measured by combining the five-level EuroQol five-dimensional questionnaire (EQ-5D-5L) utility score (change in scores 1-5 over 5 domains, 1 is best and 5 is worst), and the Quality of Recovery-15 (QoR-15) score (0-150, 0 is the worst and 150 is the best recovery).

Study contacts

Contact information is provided by the study sponsor or research team.

A. Stobbe, MSc

CONTACT

[email protected]

+31205669111

Benedikt Preckel, MSc

CONTACT

[email protected]

+31205669111

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Collaborators

  • European Society of Anaesthesiology and Intensive Care

Registry information

Official study title

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

Acronym: PRINCESS

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 8, 2023
Registry last updated
Oct 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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