Intermittent Fasting Versus Carbohydrate Drinks Before Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

History of diabetes mellitus;

History of feeding or eating disorders;

History of delayed gastric emptying or gastro-oesophageal reflux

Active malignancy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Time-restricted feeding

    Behavioral

    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 loading

    Dietary 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.

Treatment groups

75 Participants
are divided into 3 treatment groups
Group A: Time-restricted feedingExperimental treatment 1 intervention
Group B: Carbohydrate loadingActive comparator 1 intervention
Group C: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

1

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.
2

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
3

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Amsterdam UMC, location AMC

Sponsor institution

European Society of Anaesthesiology and Intensive Care

Collaborator