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Intermittent Fasting Versus Carbohydrate Drinks Before Surgery (PRINCESS)

Primary Purpose

Perioperative Care, Intermittent Fasting, Carbohydrate Loading

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Time-restricted feeding
Carbohydrate loading
Sponsored by
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Perioperative Care focused on measuring Perioperative Care, Intermittent Fasting, Carbohydrate Loading, Preoperative Fasting, Orthopedic Surgery, Insulin Resistance

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • Amsterdam UMC location AMCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Time-restricted feeding

Carbohydrate loading

Control group

Arm Description

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.

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

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 27, 2023
Last Updated
July 19, 2023
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators
European Society of Anaesthesiology and Intensive Care
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1. Study Identification

Unique Protocol Identification Number
NCT05760339
Brief Title
Intermittent Fasting Versus Carbohydrate Drinks Before Surgery
Acronym
PRINCESS
Official Title
Preoperative Intermittent Fasting Versus Carbohydrate Loading to Reduce Insulin Resistance: a Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 20, 2023 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators
European Society of Anaesthesiology and Intensive Care

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perioperative Care, Intermittent Fasting, Carbohydrate Loading, Preoperative Fasting, Orthopedic Surgery, Insulin Resistance
Keywords
Perioperative Care, Intermittent Fasting, Carbohydrate Loading, Preoperative Fasting, Orthopedic Surgery, Insulin Resistance

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Time-restricted feeding
Arm Type
Experimental
Arm Description
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.
Arm Title
Carbohydrate loading
Arm Type
Active Comparator
Arm Description
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
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Time-restricted feeding
Intervention Description
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
Dietary Supplement
Intervention Name(s)
Carbohydrate loading
Intervention Description
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.
Primary Outcome Measure Information:
Title
Insulin resistance on postoperative day 1
Description
Insulin resistance according to the homeostasis model assessment of insulin resistance (HOMA-IR)
Time Frame
Postoperative day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
R. van Wilpe, MSc
Phone
+31205669111
Email
r.vanwilpe@amsterdamumc.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Benedikt Preckel, MSc
Phone
+31205669111
Email
b.preckel@amsterdamumc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeroen Hermanides, MSc
Organizational Affiliation
Amsterdam UMC, location AMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Amsterdam UMC location AMC
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1105AZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
R. van Wilpe, MSc
Phone
+31205669111
Email
r.vanwilpe@amsterdamumc.nl

12. IPD Sharing Statement

Plan to Share IPD
No

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Intermittent Fasting Versus Carbohydrate Drinks Before Surgery

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