Perioperative CarePRINCESSNCT05760339
Intermittent Fasting Versus Carbohydrate Drinks Before Surgery
A study testing Time-restricted feeding and Carbohydrate loading in people with Perioperative Care and Intermittent Fasting, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perioperative Care, Intermittent Fasting, Carbohydrate Loading
- What is being tested?
- Time-restricted feeding and Carbohydrate loading
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteNetherlands
- Study dates
- 20 Mar 2023to Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 10Show fewer
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC location AMC
Amsterdam, North Holland, 1105AZ
R. van Wilpe, MSc, +31205669111, r.vanwilpe@amsterdamumc.nl
About this study
Official title: Preoperative Intermittent Fasting Versus Carbohydrate Loading to Reduce Insulin Resistance: a Randomised Controlled 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.
Read the detailed description
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
- Perioperative Care, Intermittent Fasting, Carbohydrate Loading, Preoperative Fasting, Orthopedic Surgery, Insulin Resistance
- Being tested
- Time-restricted feeding, Carbohydrate loading
- Keywords
- Perioperative Care, Carbohydrate Loading, Orthopedic Surgery, Insulin Resistance, HOMA-IR, Time Restricted Feeding
- Medical subject headings
- Intermittent Fasting, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time-restricted feedingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Time-restricted feeding | Experimental | 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. Receives: Behavioral: Time-restricted feeding |
| Carbohydrate loading | Active comparator | 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 Receives: Dietary Supplement: Carbohydrate loading |
| Control group | No intervention | 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin resistance on postoperative day 1
Insulin resistance according to the updated homeostasis model assessment of insulin resistance (HOMA2-IR)
Measured: Postoperative day 1
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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).
Measured: During the two weeks preoperatively, until one day postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start20 Mar 2023
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perioperative CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Sponsor type
- University, hospital or other
- Collaborators
- European Society of Anaesthesiology and Intensive Care
- Responsible party
- Principal investigator, B Preckel, Amsterdam UMC, location AMC
- Investigators
- Jeroen Hermanides, MSc, Principal investigator, Amsterdam UMC, location AMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05760339
- Sponsor's protocol ID
- PRINCESS trial
- Acronym
- PRINCESS
- Status last verified
- Oct 2024
- First submitted
- 27 Feb 2023
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available upon reasonable request following the completion of the trial and publication of the final manuscript. The shared data may include de-identified data that contains individual-level data collected during the trial. Researchers seeking data access must submit a research proposal and analysis plan outlining objectives, methodology, and relevance. If applicable, approval by a medical ethics research committee is required. Proposals will be reviewed to ensure that the request aligns with scientific and ethical standards, and data access will be granted under a data use/sharing agreement that stipulates the terms and conditions for data usage.
Publications
Stobbe AY, de Klerk ES, van Wilpe R, Kievit AJ, Choi KF, Preckel B, Hollmann MW, Hermanides J, van Stijn MFM, Hulst AH. Study protocol of the PRINCESS trial-PReoperative INtermittent fasting versus CarbohydratE loading to reduce inSulin resiStance versus standard of care in orthopaedic patients: a randomised controlled trial. BMJ Open. 2025 Jan 21;15(1):e087260. doi: 10.1136/bmjopen-2024-087260.
PubMed 39842917
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Intermittent Fasting Versus Carbohydrate Loading to Reduce Insulin Resistance: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05760339
- Acronym / sponsor ID
- PRINCESS / PRINCESS trial
- Conditions
- Perioperative Care, Intermittent Fasting, Carbohydrate Loading, Preoperative Fasting, Orthopedic Surgery, Insulin Resistance
- Keywords
- Perioperative Care, Carbohydrate Loading, Orthopedic Surgery, Insulin Resistance, HOMA-IR, Time Restricted Feeding
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- European Society of Anaesthesiology and Intensive Care
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 8 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Time-restricted feeding | Experimental | Behavioral: Time-restricted feedingSubjects 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. |
| Carbohydrate loading | Active comparator | Dietary Supplement: Carbohydrate loadingSubjects 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 |
| Control group | No intervention | –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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time-restricted feedingSubjects 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. | Behavioural | Time-restricted feeding |
| Carbohydrate loadingSubjects 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. | Dietary supplement | Carbohydrate loading |
Primary outcome
Insulin resistance on postoperative day 1
Time frame: Postoperative day 1
Insulin resistance according to the updated homeostasis model assessment of insulin resistance (HOMA2-IR)
3 secondary outcomes
Difference in HOMA2-IR
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
Time frame: The day of surgery and the first postoperative day
Patient wellbeing
Time frame: During the two weeks preoperatively, until one day postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
- Derived from this study: PubMed 39842917Stobbe AY, de Klerk ES, van Wilpe R, Kievit AJ, Choi KF, Preckel B, Hollmann MW, Hermanides J, van Stijn MFM, Hulst AH. Study protocol of the PRINCESS trial-PReoperative INtermittent fasting versus CarbohydratE loading to reduce inSulin resiStance versus standard of care in orthopaedic patients: a randomised controlled trial. BMJ Open. 2025 Jan 21;15(1):e087260. doi: 10.1136/bmjopen-2024-087260.
- Individual participant dataSharing planned: Yes. Data will be made available upon reasonable request following the completion of the trial and publication of the final manuscript. The shared data may include de-identified data that contains individual-level data collected during the trial. Researchers seeking data access must submit a research proposal and analysis plan outlining objectives, methodology, and relevance. If applicable, approval by a medical ethics research committee is required. Proposals will be reviewed to ensure that the request aligns with scientific and ethical standards, and data access will be granted under a data use/sharing agreement that stipulates the terms and conditions for data usage.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jeroen Hermanides, MSc principal investigator
Amsterdam UMC, location AMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time-restricted feeding and Carbohydrate loading in people with Perioperative Care and Intermittent Fasting, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact A. Stobbe, MSc (+31205669111, a.y.stobbe@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin resistance on postoperative day 1 (time frame: Postoperative day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05760339, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2024.