Intermittent Fasting Versus Carbohydrate Drinks Before Surgery

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Пищевая добавка 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.

Первичные конечные точки

• Insulin resistance on postoperative day 1 [Срок оценки: Postoperative day 1]

Вторичные конечные точки (3)

• Difference in HOMA2-IR [Срок оценки: From baseline to day of surgery, from baseline to postoperative day 1 and from day of surgery to postoperative day 1.]
• Beta-cell function [Срок оценки: The day of surgery and the first postoperative day]
• Patient wellbeing [Срок оценки: During the two weeks preoperatively, until one day postoperatively]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Нидерланды · 1 центр

• Amsterdam UMC location AMC — Amsterdam

Публикации

• 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. PMID 39842917

Идентификаторы

NCT: NCT05760339 · PRINCESS trial

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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