Intermittent Fasting Versus Carbohydrate Drinks Before Surgery

Insulin Resistance Clinical Trial

— PRINCESS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05760339
• Other study ID #: NL81556.018.22
• Status: Recruiting
• Phase: N/A
• Start date: March 20, 2023
• Est. completion date: February 2025

Study information

• Verified date: April 2024
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: R. van Wilpe, MSc
• Phone: +31205669111
• Email: r.vanwilpe[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate whether intermittent fasting before surgery improves insulin resistance around the time of surgery, compared to carbohydrate drinks and standard fasting before surgery.

Description:

Patients in the 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Insulin Resistance
• Intermittent Fasting
• Orthopedic Surgery
• Perioperative Care
• Preoperative Fasting

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC location AMC	Amsterdam	Noord-Holland

Sponsors (2)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	European Society of Anaesthesiology and Intensive Care

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin resistance on postoperative day 1	Insulin resistance according to the homeostasis model assessment of insulin resistance (HOMA-IR)	Postoperative day 1