Comparing intermittent fasting and carbohydrate drinks before surgery
Preoperative Intermittent Fasting Versus Carbohydrate Loading to Reduce Insulin Resistance: a Randomised Controlled Trial
NA · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · NCT05760339
This study is testing whether intermittent fasting or drinking carbohydrate drinks before surgery helps people with orthopedic issues have better metabolic health.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (other) |
| Locations | 1 site (Amsterdam, North Holland) |
| Trial ID | NCT05760339 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of time-restricted feeding (intermittent fasting) versus carbohydrate loading on insulin resistance in patients undergoing orthopedic surgery. Participants in the time-restricted feeding group will follow an 8-hour eating window and a 16-hour fasting period for two weeks prior to surgery, while the carbohydrate loading group will consume a maltodextrin beverage before surgery. The goal is to determine which approach better improves metabolic outcomes around the time of surgery.
Who should consider this trial
Good fit: Ideal candidates are adults scheduled for elective orthopedic surgery who are motivated to adhere to a time-restricted feeding regimen.
Not a fit: Patients with a history of diabetes, eating disorders, or certain other medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved metabolic health and recovery outcomes for patients undergoing orthopedic surgery.
How similar studies have performed: Other studies have shown promising results with intermittent fasting approaches, suggesting potential benefits in metabolic health, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Amsterdam, North Holland
- Amsterdam UMC location AMC — Amsterdam, North Holland, Netherlands (RECRUITING)
Study contacts
- Principal investigator: Jeroen Hermanides, MSc — Amsterdam UMC, location AMC
- Study coordinator: A. Stobbe, MSc
- Email: a.y.stobbe@amsterdamumc.nl
- Phone: +31205669111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Perioperative Care, Intermittent Fasting, Carbohydrate Loading, Preoperative Fasting, Orthopedic Surgery, Insulin Resistance, HOMA-IR, Time Restricted Feeding