PRINCESS: Intermittent Fasting Versus Carbohydrate Drinks Before Surgery

Sponsor

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

Overall Status

Not yet recruiting

CT.gov ID

NCT05760339

Collaborator

European Society of Anaesthesiology and Intensive Care (Other)

Enrollment

Location

Arms

11.1

Anticipated Duration (Months)

6.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Perioperative Care Intermittent Fasting Carbohydrate Loading Preoperative Fasting Orthopedic Surgery Insulin Resistance	Behavioral: Time-restricted feeding Dietary Supplement: Carbohydrate loading	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

75 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.
Active Comparator: 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	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.
No Intervention: 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).

Arm

Intervention/Treatment

Experimental: 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.

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.

Active Comparator: 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

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.

No Intervention: 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).

Outcome Measures

Primary Outcome Measures

Insulin resistance on postoperative day 1 [Postoperative day 1]
Insulin resistance according to the homeostasis model assessment of insulin resistance (HOMA-IR)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).