Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| European Society of Anaesthesiology and Intensive Care | OTHER |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
|
| 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin resistance on postoperative day 1 | Insulin resistance according to the updated homeostasis model assessment of insulin resistance (HOMA2-IR) | Postoperative day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline to day of surgery, from baseline to postoperative day 1 and from day of surgery to postoperative day 1. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| A. Stobbe, MSc | Contact | +31205669111 | a.y.stobbe@amsterdamumc.nl | |
| Benedikt Preckel, MSc | Contact | +31205669111 | b.preckel@amsterdamumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Jeroen Hermanides, MSc | Amsterdam UMC, location AMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam UMC location AMC | Recruiting | Amsterdam | North Holland | 1105AZ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39842917 | Derived | 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. |
Not provided
Not provided
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.
After completion of the trial and publication of the final manuscript.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
| 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. | 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). | During the two weeks preoperatively, until one day postoperatively |
| ID | Term |
|---|---|
| D000093763 | Intermittent Fasting |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000070601 | Diet, Carbohydrate Loading |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
Not provided
Not provided