Amsterdam UMC location AMC
Amsterdam, North Holland, 1105AZ, Netherlands
Location status: Recruiting
NCT Number: NCT05760339
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Amsterdam, North Holland, 1105AZ, Netherlands
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Postoperative day 1
Insulin resistance according to the updated homeostasis model assessment of insulin resistance (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.
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.
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).
Contact information is provided by the study sponsor or research team.
A. Stobbe, MSc
CONTACT
Benedikt Preckel, MSc
CONTACT
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Other
Preoperative Intermittent Fasting Versus Carbohydrate Loading to Reduce Insulin Resistance: a Randomised Controlled Trial
Acronym: PRINCESS
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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