Intermittent Fasting Versus Carbohydrate Drinks Before Surgery

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)75 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Perioperative Care Intermittent Fasting Carbohydrate Loading Preoperative Fasting

Interventions

Time-restricted feedingBEHAVIORAL

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 loadingDIETARY_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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

Insulin resistance on postoperative day 1

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

Time frame: Postoperative day 1

Secondary Outcomes

Difference in HOMA2-IR

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: From baseline to day of surgery, from baseline to postoperative day 1 and from day of surgery to postoperative day 1.

Beta-cell function

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: The day of surgery and the first postoperative day

Patient wellbeing

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).

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