The EFFect of dietary fat content on the recurrence of pancreaTitis (EFFORT): Protocol of a multicenter randomized controlled trial

Pancreatology. 2022 Jan;22(1):51-57. doi: 10.1016/j.pan.2021.10.002. Epub 2021 Oct 14.

Abstract

Background: Around 20% of patients with acute pancreatitis (AP) will develop acute recurrent pancreatitis (ARP) and 10% will progress to chronic pancreatitis. While interventions to avoid recurrences exist for the two most common causes - abstinence for alcoholic and cholecystectomy for biliary pancreatitis - the are no known preventive measures in idiopathic ARP. Though it is not included in any of the guidelines, a low-fat diet is often recommended. Our aim is to test dietary fat reduction's effect on AP recurrence in a randomized controlled setting, in order to provide high-quality evidence for the validity of such an intervention.

Methods, design: Participants with at least 2 episodes of AP in the preceding 2 years of which the last episode was idiopathic will be randomized to one of two diets with different fat contents: a 'reduced fat diet' (15% fat, 65% carbohydrate, 20% protein) and a 'standard healthy diet' (30% fat, 50% carbohydrate, 20% protein; based on WHO recommendations). Participants will be followed-up for 2 years (visits will be scheduled for months 3, 6, 12, 18 and 24) during which they will receive a repeated session of nutritional guidance, complete food frequency questionnaires and data on relapse, mortality, BMI, cardiovascular parameters and serum lipid values will be collected.

Discussion: This study will determine the effect of modifying the dietary fat content on AP recurrence, mortality, serum lipids and weight loss in idiopathic cases.

Keywords: Diet; Fat-content; Lipids; Pancreatitis; Recurrence.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Acute Disease
  • Carbohydrates
  • Dietary Fats*
  • Humans
  • Multicenter Studies as Topic
  • Pancreatitis, Chronic*
  • Randomized Controlled Trials as Topic
  • Recurrence

Substances

  • Carbohydrates
  • Dietary Fats