Intermittent Fasting Versus Carbohydrate Drinks Before Surgery
Preoperative Intermittent Fasting Versus Carbohydrate Loading to Reduce Insulin Resistance: a Randomised Controlled Trial
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
75 participants
Mar 20, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria10
- 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).
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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05760339