Intermittent Fasting Versus Carbohydrate Drinks Before Surgery

Not Applicable

Recruiting

• Conditions: Perioperative Care; Carbohydrate Loading; Orthopedic Surgery; Insulin Resistance; Intermittent Fasting; Preoperative Fasting
• Interventions: Behavioral: Time-restricted feeding; Dietary Supplement: Carbohydrate loading

• Registration Number: NCT05760339
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief 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.

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.

Study Timeline

• Study First Submitted: 2023-02-27
• Study First Submitted QC: 2023-02-27
• Study First Posted: 2023-03-08
• Study Start: 2023-03-20
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-18
• Last Update Posted: 2024-10-22
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Time-restricted feeding	Time-restricted feeding	Subjects will follow a daily time-restricted feeding 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.
Carbohydrate loading	Carbohydrate loading	Subjects 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

Primary Outcome Measures

Name	Time	Method
Insulin resistance on postoperative day 1	Postoperative day 1	Insulin resistance according to the updated homeostasis model assessment of insulin resistance (HOMA2-IR)

Secondary Outcome Measures

Name	Time	Method
Difference in HOMA2-IR	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.
Beta-cell function	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.
Patient wellbeing	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).

Trial Locations

Locations (1)

Amsterdam UMC location AMC; 🇳🇱 Amsterdam, Noord-Holland, Netherlands