Intermittent Fasting Versus Carbohydrate Drinks Before Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-20

Study Completion Date

2025-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Perioperative Care Intermittent Fasting Carbohydrate Loading Preoperative Fasting Orthopedic Surgery Insulin Resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Time-restricted feeding

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

Carbohydrate loading

Intervention Type 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.

Control group

Subjects will continue their usual diet and proceed with standard preoperative fasting (i.e., eat up until 6 hours and take clear liquids up until 2 hours before induction of anaesthesia).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No